How to Document Risk in your 510(k)

You can document Risk in a 510(k) by comparing subject device with one or more similar legally marketed devices to support substantial equivalency claims. To legally market your medical device, you need to demonstrate it is as safe and effective as any other legally marketed product that is not subject to PMA (21 CFR 807.92(a)(3)).

The blog describes key factors for documenting risk management in 510(k) submissions. Here is a list of questions we should understand:

  • What is a predicate device and how to claim substantial equivalence to a proposed device?
  • Types of devices needing risk management for 510(k) submissions?
  • Risk management requirements for a Traditional 510(k)?
  • Where can one find 510(k) risk management requirements?
  • How can manufacturers demonstrate device safety?
  • Key factors for documenting risks before submitting 510(k)?
  • Contents of software related documentation?
  • What are the contents of risk related documentation?


Using Substantial equivalence to demonstrate risk management in the 510(k) submission. 

A predicate device is a legally marketed device subjected to premarket approval. We can demonstrate Substantial Equivalence by comparing the applicant’s device to a cleared predicate device, if:

  • it was cleared through the 510(k) process
  • it was legally marketed prior to May 28, 1976 (pre-amendments device)
  • it was originally on the U.S. market as a Class III device (Premarket approval) and later down-classified to Class II or I
  • it is a 510(k)-exempt device

We can demonstrate substantial equivalence if predicate device has:

  • The same intended use as the predicate; and
    • the same technological characteristics as the predicate
  • The same intended use as the predicate; and
    • different technological characteristics and the information submitted to FDA and
    • does not raise new questions of safety and effectiveness; and
    • demonstrates that the device is at least as safe and effective as the legally marketed device.
  • Same technical characteristics can be:
    • The design
    • Energy used or delivered
    • Materials of construction
    • Performance
    • Safety
    • Effectiveness
    • Labeling
    • Biocompatibility
    • Environmental conditions
    • Storage/ transport
    • operating

If the new device has some different technological characteristics the differences must not raise questions of safety or effectiveness when you’re testing the device as safe and effective as the predicate device. However, if testing is done in accordance with FDA recognized standard then certificate of compliance to that standard is sufficient for the submission, and global test information or test data is not required.

A simple way to show substantial equivalence is to create a comparison table including: 

  • Technological specifications mentioned below:
    • Intended use, Indications for use
    • Target population, Anatomical sites, where used (hospital, home, etc.)
    • Energy used and/or delivered
    • Human factors, Design, Performance, Standards met, Materials, Biocompatibility, Compatibility with environment and other devices
    • Sterility, Electrical safety, Mechanical safety, Chemical safety, Thermal safety, Radiation safety
  • A Narrative discussing similarities and differences between new and predicate device


Devices requiring risk management for 510(k) submission.

  • Risk management requirements are only for devices that contain software.
  • Abbreviated 510(k)s generally require declarations of conformity and risk management documents


Risk management requirements for a Traditional 510(k). 

Only embedded software, driven by or standalone software and devices with software component must include Hazard Identification and Risk Assessment in 510(k)s.

When there is insufficient information to create general controls, special controls provide reasonable assurance of safety and effectiveness. It assures FDA that hazards related to device development process were subject to controls and mitigations.

You should include Risk Control Verification and Validation requirements under

  • Packaging Validation
    • Sterilization Validation
    • Biocompatibility
    • Software Verification Validation
    • Electrical Safety and EMC
    • Bench/Pre-Clinical Performance Testing
    • Animal Performance Testing
    • Clinical Performance Testing

Risks to Users and Patients are addressed in the Instructions for Use (IFU) as warnings, contraindications, and precautions (typically because of usability studies and hazard analysis).

Risk-Benefit Analysis is required in Special 510(k)s, De Novo applications, Humanitarian Device Exemptions, and PMAs. It is not required for traditional 510(k).

Where can one find 510(k) risk management requirements?

Design validation-software validation and risk analysis (21 CFR 820.30) FDA and EU CE Marking compliance- recognize ISO 14971 standard:

  • FDA recognizes ISO 14971:2019
  • EU recognizes EN ISO 14971:2019 (differences include omission of Annexes, decoupling of standards to MDR regs),

Best practices to address risks in 510(k) submissions

  • Look for appropriate Special Controls Guidance Docs in the FDA Guidance Document
  • Use Guidance Documents for Controls and Risk Management Requirements
  • Examine the guidance and determine which standards, testing, and hazard/risk analyses are appropriate.
  • Ensure extensive testing

How to demonstrate device safety?

The GHTF/SG1-N11:2008 in 10.0 Risk Analysis and Control Summary states that “The STED [Summary Technical Documentation] should contain a summary of the risks identified during the risk analysis process and how these risks have been controlled to an acceptable level. Preferably, this risk analysis should be based on recognized standards and be part of the manufacturer’s risk management plan.”

Factors to consider regarding risks before submitting 510(k)?

Human factors:

“Medical device manufacturers are required to follow FDA’s Human Factors guidance and regulations to help ensure safe use of these devices.” – CDRH website

Recognized standards include ISO 14971 risk management standard, IEC 62366 (joint ISO/IEC standard applying to all devices), IEC 60601-1-6 and AAMI HE75. To comply with standards,

  • Manufacturers will have to develop usability specifications for devices
  • Manufacturers should explore usability issues as part of the risk management process in compliance with standards
  • Include Usability evaluations as part of design validations

The FDA requires a summary of these actions as part of a human factors dossier while submitting pre-market information, which is explained in detail below:

  • Description of device user interface
  • Description of user interaction with UI (use scenarios)
    • Device, Training, Labeling, IFU
  • intended users, uses, use environments and training
  • Summary of known use problems from:
    • Predecessor devices
    • Similar devices
  • Analysis of hazards and risks associated with the use of the device
  • Summary of preliminary analyses and evaluations
  • Description and categorization of critical tasks
  • Details of human factors validation testing
    • Description of test participants (minimum of 15 in each user population)
    • Description of test scenarios
    • Moderator guideline
    • Training offered
    • Test results
    • Test results summary
  • Conclusion


Content of Software-related risk documentation.

In the 510(k) submission, medical device manufacturers must:

  • show they identified hazards appropriately and managed risks effectively and
  • provide traceability to link design, implementation, testing, and risk management.

The following information is picked from the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005

Device Hazard Analysis: Tabular description of identified hardware and software hazards, including severity assessment and mitigations.

Traceability Analysis: Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing.

When performing a hazard analysis, it is recommended that you address all foreseeable hazards, including those resulting from intentional or inadvertent misuse of the device.

The risk documentation for software can be in the form of an extract of the software-related items from a comprehensive risk management document, such as the Risk Management Summary described in ISO 14971. In this format, each line item should include:

  • identification of the hazardous event
  • the severity of the hazard i.e., level of concern
  • cause(s) of the hazard i.e., device Hazard analysis
  • method of control (e.g., alarm, hardware design)
  • corrective measures taken, including an explanation of the aspects of the device design/requirements, that eliminate, reduce, or warn of a hazardous event; and
  • verification that the method of control was implemented correctly.
  • Software Description
  • Software Requirements Specification (SRS)
  • Architecture Design Chart
  • Software Design Specification (SDS)
  • Traceability Analysis
  • Software Development Environment Description
  • Configuration management & maintenance plan
  • Verification/ validation Documentation
  • Revision Level History
  • Unresolved anomalies
  • Impact on safety or effectiveness discussion
  • Rationale for accepting

It is recommended to base your estimation of risk for your Software Device on the severity of the hazard resulting from failure, assuming that the failure will occur. You need to use risk identification and control techniques described in consensus standards such as ISO 14971.

Documenting risk in 510(k)

After analyzing the previous material, it is evident that ISO 14971 has identified a method for providing the information necessary by the FDA, namely the traceability summary required in Clause 3.5 of the risk management file.

The information can be provided in a document that is displayed in the GHTF guidance, GHTF/SG3/N15R8 Implementation of risk management principles and activities within a Quality Management System Annex C. 

Example of Risk Management Summary Table
Example of Risk Management Summary Table










Risk Traceability Summary

You can add a column with reference to the source document listing each hazard and additional information to improve the use of Risk Traceability Summary, for example:

  • A Human Factors or Usability study that identifies hazards
  • A standard that identifies a hazard and possibly a risk control method
  • MAUDE database identified hazard from predicate device
  • Complaint file from previous similar product

Risk Information in 510(k)

Provide a copy of the Risk Chart, which specifies the Risk Acceptability levels for the product in the submission, and include copies of the definitions of Severity Levels and the Probability of Occurrence Levels.

Take care of probability levels to ensure there is evidence to support the quantified levels and the ranges do not overlap.

Risk Chart Communicating Risk Management

Risk chart communicating risk management activities


Managing 510(k) is a tedious process, requiring data from various teams and several elements of test strategy. However, you can still navigate the process of organizing all the data in a simple yet comprehensive manner. It is important to remember that FDA reviewers can only review so much detail, and therefore randomly put together irrelevant data can cause delays in receiving approval. Therefore too much information can negatively impact 510(k) review timelines. It is a manufacturer’s responsibility to submit data accurately and present it in an easily comprehensible format. FDA can have many questions after the application is submitted, and they need to be responded promptly by going back to the source of data and responding to FDA to compress your approval cycle.

Leveraging Regulatory Management Technology (RIM) to build your medical device technical files and 510(k) submissions will help you avoid inconsistency, maintain clarity for managing submission requirements helping you streamline only those processes and parts of of section of your document that need additional detail.

About Essenvia

Essenvia is a regulatory lifecycle management solution to help you optimize the entire regulatory operations process. Our Regulatory Management Software solutions include an innovative approach to building your pre-market submissions like 510(k) and MDR/ IVDR as well as post-market submissions like Regulatory Change Assessment and Post Market Surveillance. Our solution reduces errors, streamlines regulatory process, and guarantees faster regulatory clearance for your medical device.

Schedule a demo now to find out how Essenvia can help you with your regulatory submissions.

510k vs PMA for Medical Devices

510k vs PMA Submissions for Medical Devices in the United States

510k vs PMA Submissions for Medical Devices in United States

When manufacturers plan to launch a medical device into the United States market, one of the most crucial steps is obtaining FDA clearance. To get that clearance, applicants must demonstrate to the Food and Drug Administration (FDA) that their device is safe and effective. Medical devices usually require either FDA clearance, aka premarket notification (PMN) or FDA Approval aka premarket approval (PMA).

Which devices call for a 510k submission vs which need PMA? The answer depends on FDA’s guidelines for medical device classification.

How the FDA Classifies Medical Devices

Under FDA guidelines, all medical devices fall under three categories, generally corresponding to the device’s risk profile.

  • Class I includes simple, minimal-risk devices. These medical devices comply with general regulatory controls and usually do not require premarket submissions. Examples of Class I devices include examination gloves, electric toothbrushes, and elastic bandages.
  • Class II devices may involve small to moderate risks to the user. These type of devices requires a 510k submission before entering the market. Devices of this class include items like powered wheelchairs, intravenous kits, and some pregnancy testing kits.
  • Class III includes mainly implanted or life-sustaining high-risk devices that could cause significant harm to patients in case of a malfunction. Class III devices include implantable pacemakers, cochlear implants, and renal stents. All devices of this class require premarket approval before marketing.

510k vs PMA Applications: The Main Differences

510k submissions for Class II medical devices and PMA for Class III devices use different regulatory processes. In a nutshell, since Class III devices are crucial for patients’ health and life, the FDA applies far stricter regulations to this type of medical device.

510k Submissions

Class II devices are seldom completely innovative. The main goal of a 510k submission is proving to the FDA that the device is essentially equivalent to a similar predicate device that the FDA has already cleared for marketing.

For example, if a company plans to market a new blood pressure cuff, this device may offer several advantages over existing products, but its core functions are still similar to other blood pressure cuffs. The legal term for this similarity is “Substantial Equivalence” (SE). A 510k submission should demonstrate substantial equivalence by comparing the applicant’s device to an approved predicate device.

510k submissions typically require laboratory testing, but not human testing. The submission form normally includes information like device characteristics, intended use, and indications for use.

The processing time for 510k submissions is usually within 30 to 90 days. If FDA accepts the application, they will post the submission to the FDA 510k database.

It’s vital to note that a successful 510k submission means that a device is FDA-cleared rather than FDA-approved. Using the correct legal terminology is important to prevent medical litigation.

PMA Submissions

PMA submissions must comply with far more rigorous standards compared to 510k to prove device safety and effectiveness. Typically, Class III devices require both laboratory testing and clinical trials that include human participants. The FDA usually processes PMA applications within 180 days.

De Novo Applications

A minority of low-risk devices introduce completely original processes or functions that disqualify them from approval based on substantial equivalence to a predicate device. These devices, while not presenting a significant risk to the user, may not get FDA clearance through a 510k submission.

Manufacturers of novel low-risk devices can submit their products for FDA approval using the de novo process, which assigns a proper classification to the device. Devices cleared for marketing through this pathway may function as predicates for future similar products.

How to Avoid Potential Problems with FDA Clearance Submissions

To get a medical device to the U.S. market as fast as possible, applicants need to ensure a snag-free 510k clearance process. Many companies face delays in getting 510k clearance because of several common and preventable errors.

Here are a few examples of mistakes that could cause delays or lead to FDA refusing to accept a 510k submission.

  • Inconsistent documentation, such as an imprecise restating of the intended use statement or mix-ups between indicated use and intended use
  • Failure to comply with FDA guidance documents such as the RTA (Refuse to Accept) checklist
  • Insufficient testing, such as not providing the results of biocompatibility tests or not including sufficiently detailed results, reports, or protocols
  • Poor risk management documentation, such as failure to demonstrate a product’s safety
  • Failure to demonstrate substantial equivalence and show that a medical device is sufficiently similar to existing FDA-cleared devices
  • Incorrect formatting of the submission, including file name and size

Medical device manufacturers can maximize their chances of obtaining 510k clearance on the first attempt by:

  • making sure to complete all the sections required by FDA including the Refuse to Accept checklist
  • completing all testing before submission, including all necessary data and protocols
  • providing an accurate comparative analysis of a predicate device

Even the most complete and thorough submission forms may bring forth follow-up questions from the FDA. If this happens, applicants should review the questions thoroughly and make sure to provide concise strategic responses.

How Essenvia Can Help With 510k Submissions to get FDA Clearance

Technical hiccups at the 510k clearance stage can cost manufacturers a lot of time, frustration, and money. An unexpected rejection of a 510k application could delay a marketing campaign or stall negotiations with vendors. In some cases, a competitor could cut in and launch a similar product earlier simply because they got their 510k submission processed more quickly.

Essenvia is here to help manufacturers get their medical devices to market as quickly and efficiently as possible. Essenvia’s platform streamlines regulatory application processes for 510k clearance and MDR submissions, ensuring speed and accuracy with collaboration built-in.

Essenvia can save over 40 work hours, which companies can invest in more important tasks like product development, testing, and marketing. The secure, easy-to-use platform includes up-to-date templates, collaborative authoring, and one-click publishing.

Essenvia: Simplifying FDA Applications

Regulatory agencies like FDA reject more than one-third of medical device applications due to technical errors like omissions and inaccuracies. Essenvia’s 510k Application Builder streamlines FDA applications by offering the latest templates, seamless collaboration, and more across the entire life cycle of the medical device.

Complete your 510(k) or MDR application and launch your device faster with Essenvia. Schedule a demo now to find out how Essenvia can help you with your regulatory submissions.

What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy


Medical device manufacturers who intend to introduce a device into commercial distribution in the United States must submit a premarket notification – 510(k) or PMN to the FDA.This rule is applicable whether you are introducing a device for the first time, or planning a reintroduction with significant modifications. To ensure this rule is followed, you must leverage the information found in the FDA 510 (k) database.

This regulatory submission allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. These categories include: Class I or Class II- with or without exemptions or Class III Premarket Approval (PMA).

If your device is classified as Class I or II, and if it is not exempt, a 510(k) will be required for marketing.

510(k) Submission Pathway:

A 510(k) is a premarket submission that needs to be sent to the FDA to demonstrate that the device to be marketed is safe and effective. It will also prove the device is substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

Once the device is determined to be substantially equivalent and cleared by FDA it can then be marketed in the U.S. The substantially equivalent determination is usually made within 90 days. This determination is based on the information submitted by medical device company seeking the clearance.

However, before you decide whether your device is eligible for the 510(k) pathway it is critical that you understand the regulatory strategy for your device.

The important elements of a regulatory strategy include:

  • FDA Product Code
  • Regulation Number
  • Proposed Indications For Use
  • Testing requirements
  • Product and device-specific guidance documents

In the paragraphs to follow we explain how the FDA 510(k) database is the ideal resource for medical device manufacturers to assess and determine their regulatory strategy to market.

How to use the FDA 510(k) Database to assess your regulatory strategy:

FDA maintains a database of previously cleared 510(k)s on its website. Typically, they will add new devices around the 5th of each month for devices cleared in the prior month. Users can search for previously cleared 510(k) submissions from this database using search criteria such as but not limited to:

  • 510(k) Number
  • Applicant Name
  • Product Code
  • Device name

Steps to performing an efficient 510(k) database search:

The following steps outline how to use the FDA 510(k) database to create your regulatory strategy and manage ongoing updates:

  1. Prepare your 510(k) search criteria:

    1. For creating an effective regulatory strategy it is extremely important to take a methodical approach. The first step, therefore, is to document the technological characteristics, the intended use, and the desired indications of use for your device. Also, identify intended users of your product. This may include patients, caregivers, or healthcare professionals.
    2. Build your initial keywords list based on the important attributes describe the technology (for example a needle, a catheter, etc.). This key word list also includes the indications and mode of action for the device. These keywords are attributes that when combined represent your device.
    3. Identify and list your competitors and the devices they have marketed or received approval for. We will talk about how to use this information later in this article.
  2. Perform a search of the 510(k) database

    1. There are two ways to run an efficient search on the FDA 510(k) database: (1) Quick search and (2) Advanced search. We will discuss how to leverage each of these search methods to optimize this FDA resource.A quick search on the 510(k) database with your keywords is helpful to identify a list of devices that match your device category.Below is an example of how this search works using an apnea monitor as the device
    2. Click search to view the list of devices that have a name apnea on them. This lists the devices with the keyword Apnea in them with decision dates and applicant information, all of which is valuable information that you can use for your own application.
    3. Click on the device name to see the regulatory attributes such as medical speciality, common name, and regulation number, and text. Scan the list and note down the products and regulatory attributes that look relevant. Also, click on the 510(k) Number and note down additional details for further use in the advanced search.
    4. The advanced search screen (shown below) is helpful when you already have key data on your competitors such as their 510(k) number or three letter product code. It is also helpful if are already confident the device in questions is similar to yours.
  3. Assimilate results, compare relevant attributes, and rank order search results

    Now that you have collected product code, regulations, and summary documents of possible similar devices, it is time to compare them with your technology, indications, mode of action and components. As well as, identifying the one that is closest to your device.This will then help you identify the applicable tests and guidance documents relevant to your device. This will inform your broader regulatory strategy and therefore your budget and timelines to go to market.

  4. Managing Regulatory strategy and ongoing regulatory Intelligence

    Regulatory assessment is a task that medical device companies must complete regularly in order to stay current with the latest regulatory changes. It is paramount that regulatory teams maintain a proactive approach to understand and assess the impact of changes to regulations, standards, and new guidance documents published by FDA, as well as device recalls of similar devices or changes in the product category.

    Methods used today include manually searching in guidance documents, standards databases, recalls and MAUDE reports databases that FDA has made available for public search. A slightly more sophisticated approach is subscribing to a plethora of industry journals, attending conferences, subscribing to FDA newsletters and notifications to stay up-to-date.

    The problem with this approach is regulatory affairs specialists and leaders end up consuming a lot of data from disparate data sources and struggle to make sense out of it all. This requires an audit of these sources to narrow down the information relevant to your device. Then, you need to assess what you just learned and recommend a course of action. With the number of rapid changes occurring every day, these approaches quickly become unmanageable.

Limitations of the current process to search in FDA 510(k) Database:

Whether you are using keywords-based search or competitor data for regulatory strategy, these searches can take hours. You also risk the possibility of omission due to the time the number of records that need to be reviewed.

Evaluating competitor technology could be helpful. However, elements such as technological characteristics, materials, and mode of action do not always equal a device that you can use to show substantial equivalence.

Therefore, finding the right substantially equivalent device seldom involves a straightforward strategy. Instead, it is the result of hours of careful preparation of a combination of keywords. This list that can identify a list of devices already in the market and then doing a couple of passes to compile a list of devices and technology.

The siloed process of passively managing regulatory attributes, strategy, and search criteria while spending hours scouring the internet is time-consuming and prone to error. Reviewing the regulatory attributes alongside the technology profile will help you identify the ideal devices to use to establish substantial equivalence.

A better way to manage regulatory search and intelligence

What if there is a way to combine all the steps mentioned above and streamline the entire process? A tool that can allow you to preview and analyze critical regulatory attributes for specific devices that are ranked by relevance based on your list of keywords.

What if you were are able to pull the documents from previous searches? What if your team could leverage a system that understands important attributes and can also notify you when changes occur.

As busy regulatory specialists, leads, and executives in medical device companies, your strength lies in your ability to make great decisions substantiated by data points. Therefore access to relevant regulatory information curated without noise can save hours and sometimes days and it can be a long-term competitive driver of medical device innovation.

5 Reasons You Shouldn’t Work on Your 510(k) Submission Alone

First, you conceptualize your idea for a new medical device. Your team has determined what medical issue it is going to resolve and how it will be used. Then, you research the current state of the market to understand the level of need and how to best position it. Your cross-functional teams spend time designing your device and ensuring it is easy to use. Finally, you are ready build your 510(k) submission to submit your device for FDA clearance.

 Obtaining FDA clearance for your device involves submitting a 510(k) application. This application is normally over 1,100 pages and requires a plethora of information. The sheer size of this application will leave you open to all types of mistakes. Theses mistakes can lead to your application being rejected.

The FDA will provide general guidance regarding what needs to be included in a 510(k) application. However, they provide little else in terms of document organization or project management. This often leaves submitters alone with a checklist and blank Microsoft word document. Then forced to wrangle hundreds of pages of information such as packaging labels, clinical trial reports and more.

In this post, we cover the top 5 reasons why you should not go it alone when submitting your 510(k) application.

#1 – You Need To Have The Most Up To Date FDA Documents

Your 510(k) application, you will include several places that require FDA documents. The FDA will supply these documents as they are necessary for submitting a complete application. However, documents and forms such as your Cover Sheet, Indication of Use, and Declaration of Conformity to a Recognized standard change often. It can be difficult to know if you are using the most up-to-date version. The last thing you want is to learn you are not compliant by having your application rejected.

These types of requirements can lead to errors among those who are doing this on their own. However, using a 510(k) application builder tool like ours ensures you always have to right templates. We automatically populate your application with the most up-to-date FDA templates. All you need to do is fill in the necessary information.

For example, the FDA requires a specific form for your device’s Indication of Use statement. This document explains what you plan to use your device for after receiving clearance. This is also a document that the FDA tends to update regularly. As anyone who has used the FDA website will tell you, these documents are not easily accessible. Our 510(k) builder always provides the most up-to-date form and automatically inserts it into your application.

#2 – Discrepancies and Errors Will Lead To Rejection Of Your 510(k) Submission

A key reason automation has become so popular in today’s society is it cuts down on both time and errors. Brands no longer require their sales reps to manually type out their outreach emails because it is highly likely there will be a typo or incorrect statement. The pitfalls of manual data entry are just as evident when it comes to 510(k) applications.

The application will require you to repeat the same key information such as indications for us and device descriptions in several places. For example, your indication of use statement is a key point that the FDA will review. Even if you are clear on what that statement is, it’s possible it can be phrased in several different ways.

If the reviewer feels this statement is inconsistent, they will reject your application. In our application builder, we ensure this type of content is consistent throughout your entire application. All you need to do is type it once and our Changelock™ function ensures your information cascades to all relevant sections throughout your application.

#3 – You Have A Lot Of People You Need To Communicate With

As the saying goes: If you want something done right, do it yourself. Regardless if you agree, one undeniably true fact is that you cannot compile the data and information you need for a 510(k) by yourself. As the project lead, you are required to communicate with several people both inside and outside your organization. This requires countless emails, dropbox folders, JIRA tickets, and anything else that delivers the content you require.

Ongoing communication amongst this many parties is ripe for confusion and errors. This is due in large part to your teammates not being well versed in regulatory terminology. They are also not nearly as knowledgeable as you are about the various requirements set by the FDA. Therefore, it is your responsibility to translate their work into content that follows the proper terminology and requirements.

A system must be put in place on day one. A process that allows you to get a handle on the various documents that are floating in your direction. You will benefit greatly from a program that helps collect this information and store it in an organized manner. This will relieve your stress and allow you to confidently move forward knowing you have the most up-to-date and accurate versions of everything you need.

#4 – The Fear and Anxiousness Of Getting You 510(k) Submission Wrong

Gaining FDA approval is a daunting and pressure-packed task. This is the major hurdle stopping your device from hitting the market and turning a profit for your organization. Key stakeholders including executives, shareholders, investors, and team members are looking for you to deliver. Messing up could mean a loss in revenue, decreased profits, and possibly even losing key investments. That scenario is enough to paralyze anyone with fear and anxiety.

While you cannot minimize the importance of a 510(k) application or decrease its size, you can determine the best way to approach it. This includes setting up a process that safeguards against errors, discrepancies, and the use of outdated documents. When you leverage the power of our app builder, you no longer fear making a crucial mistake such as using the wrong template or forgetting to update a section of your application. Your anxiety will significantly lessen knowing you took the necessary steps to produce an error-free and rejection-proof application.

#5 – Your Time Is Better Spent On Other Sections Of Your 510(k) Submission

The truth of the matter is your time is precious and better served working on other things. While putting together this submission may be your top priority, that does mean you have time to waste hunting down the latest FDA documents and ensuring the information people are sending you is up to date. Furthermore, it should not be your responsibility to then take these thousands of pages and attempt to use Microsoft Word to comply with the FDA’s mandated e-copy format.

On the topic of time-consuming tasks, it is worth talking about the RTA checklist that is required at the end of each submission. This is a time-consuming document that appears after you just spent countless hours compiling and formatting your entire application. Our software will automatically tell you which parts of this checklist apply to your device. Then, it provides a convenient function that allows you to answer the questions as you complete the section instead of at the end of the process.

We can’t perform most of the leg work for you but we will make it easier to compile and organize what you do collect. We also make sure you are not wasting your time worrying whether or not what you are submitting will be rejected by the FDA. The time we save you can be better spent tending to your other tasks and responsibilities.


Submitting a 510(k) application is a complex process that requires the help of an experienced expert. The sheer size of this project leaves most people open to errors and mistakes that result in being rejected. Our program has identified these common areas of mistake and provides solutions to ensure that they do not happen to you. Together, we can submit a 510(k) application that you can feel confident will be approved by the FDA.

About Essenvia

Essenvia is an online software to streamline pre and post-market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration, and automating steps to manage initial and subsequent device modifications.

Our tool is designed to help drastically reduce submission errors, streamline data and information gathering, save time, and help you submit a close to rejection proof as possible 510(k) submission.

510(k) submission

The Top 5 Reasons The FDA Rejects A 510(k) Submission

If you have ever put together a 510(k) submission, you know exactly how massive of an undertaking this project becomes. You spend hours and hours collecting data and documents from various departments. You then spend more time finding the right templates and trying to understand the FDA’s guidelines. Plus, you have to search for the most up-to-date templates to use. After all of this hard work, the last thing you want is to discover the FDA has rejected your application.

Unfortunately, this is what happens to over 64% of 510(k) applications submitted for FDA clearance. Over 30% of these applications are not even accepted for initial review. Having a worthy device and the content to back it up is not enough to achieve FDA clearance. In this post, we cover the 5 most common reasons a 510(k) gets flagged and to avoid it.

#1 – Using Incorrect Or Out of Date FDA Templates

There are several sections throughout your 510(k) submission that require you to use some type of FDA-issued form. These sections include your Medical Device User Fee Cover Sheet (From FDA 3601), CDRH Premarket Coversheet (Form 3514), Cover Letter, and Indications for Use (Form 3381). Each section requires you to use the latest FDA-approved template when submitting your application.

The FDA is regularly updating these templates which makes it increasingly difficult to keep yup. While using the wrong template may not result in an outright rejection, it does put your application at risk of leaving out key information. Essenvia’s 510k application builder will always supply you with the most up-to-date templates. This helps avoid wasting hours scouring the internet and hoping you found the right templates. Furthermore, you can submit your application in confidence and no longer worry about submitting an out-of-date template and missing key information.

#2 – Discrepancies In Information That Appears More Than Once

As we mentioned above, the quality of your device and the content you provide are only part of this complex process. The FDA is quite strict when it comes to consistency in the information you provide. For example, your Indication for Use Statement appears over 20 times in your application and the FDA requires it remains the same throughout. Even if the intent remains unchanged, your application will be flagged, paused, and possibly even rejected if the wording does not match up.

It may seem simple enough to pay extra special attention when repeating information throughout your application. However, what happens when something changes towards the end of your process? You are now forced to scan your entire document and manually make this change each time. With Essenvia, this tedious type of work is done for you. With our Changelock™ feature, once you make this change on one page, it cascades throughout your entire document. You no longer have to worry if you missed a section during your review.

#3 – Not Following The 510(k) Submission Refusal To Accept Checklist

As we mentioned earlier, over 30% of submissions are rejected before they are even reviewed by a real person. This is due to their failure to comply with the Refusal To Accept checklist. In simple terms, the RTA checklist is what the FDA uses to determine if your device meets the minimum threshold for review. This document proves that you are worthy of the FDA’s time and have a realistic shot of gaining clearance.

This checklist consists of 56 questions all about the content and information in each section of your application. If you want until the end to fill it out, you risk providing answers that are not consistent with what you provided earlier. It’s important to note that not every question applies to your device. Our application builder not only shows you which questions are applicable but allows you to answer them as you are putting your sections together.

#4 – Choosing The Incorrect Predicate Device For Your 510(k) Submission

As you may already be aware, the FDA requires all submissions to list a predicate device on their application. Essentially, it is your responsibility to select a device already on the market that is substantially equivalent to the device you are seeking approval for. This is one key way the FDA can determine if your device is safe and effective. You can review current devices and their information by searching the FDA’s medical device databases.

Your Indication of Use Statement must align with the predicate device you have chosen. Whatever you decide your device is going to do it must match up with what your predicate device already does. It is equally important that your device’s technological characteristics are similar to those of the predicate device you have chosen. To increase your chances of clearance, you can include a side-by-side comparison for the reviewer to examine.

#5 – Skipping Not Applicable Sections In Your 510(k) Submission

While a traditional 510(k) includes 20 sections, not every single one of them will apply to your device. This includes sections such as Class 3 Summary and Certification, Financial Certification or Disclosure Statement, Performance Testing (Bench and Clinical) Proposed Labeling, Biocompatibility, Sterilization, and Shelf Life, and Electromagnetic Compatibility and Electrical Safety. A common mistake made by first-time submitters is leaving these sections blank instead of using a standard not applicable statement.

Even if the section does not apply to you, you are still required to state that in writing. Our application builder software will auto-populate these sections with pre-approved statements. This allows you to move past these parts of the application and focus on those that are applicable and important.


As you can see, compiling the content and data is only half the battle. The FDA expects and requires you to follow various guidelines and procedures. These requirements are why investing in a support program like Essenvia will return a high ROI. Together, we can make sure you submit a rejection proof 510(k) application and that all of your hard work will be worth it.

About Essenvia

Essenvia is an online software to streamline pre and post-market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration, and automating steps to manage initial and subsequent device modifications.

Our tool is designed to help drastically reduce submission errors, streamline data and information gathering, save time, and help you submit a close to rejection proof as possible 510k submission.