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.


How Essenvia’s Latest Updates Help Create An Accurate Regulatory Submission

Being in charge of a regulatory submission for a medical device means managing a complex project with various moving parts and several contributors. If mismanaged, not only does the project face delays but your regulatory submission could get rejected. This will undoubtedly cost your company both time and money.

Essenvia is committed to ensuring this does not happen to your medical device. We provide a tool aimed at supporting your medical device throughout its entire regulatory lifecycle.

However, that support includes more than providing up-to-date templates and features that help compile an error-proof regulatory submission. We also keep the cross-functional teams in mind when making updates to our regulatory submission builder product. Our latest update focuses on providing a faster, cleaner, more user-friendly experience for anyone using Essenvia for their regulatory submissions.

Authoring Sections within Regulatory Submission

We worked with regulatory specialists to understand what improvements would optimize their overall workflow. Therefore, one of the pillars of our latest product update is the authoring environment for sections in the project. We have revamped the way you access the authoring environment as well as what is displayed in the authoring environment to give it a huge performance boost. The new “Project Section” screen from where you access the authoring environment will also list key information such as the status of the section, percentage completion, and who on the team has access to it.

The user experience enhancement to the authoring environment allows the user to focus strictly on the section at hand, while only the sub-sections for that particular section are viewable in the left-hand navigation menu.

Quickly Locate Key Project Management Information

As a project owner or manager, you have a lot of data and information to manage and report on. Therefore, we have completely overhauled project management within Essenvia to organize key data better. This includes providing a new status overview dashboard that provides real-time updates that can be shared with team members and key stakeholders.

With our new project overview screen, you now have key information at your fingertips, such as:

Project Status

  • Days until due

  • Percentage completion

  • Draft or Published

  • List of user activity

Section Status

  • Number of sections in the draft state

  • Number of sections currently under review

Making Cross-Functional Team Collaboration Easier Than Ever

We’ve made inviting a team member to collaborate on the project easier as well. You can share project access with a co-worker by inviting a team member directly from the “Team” screen within the project. You no longer need to add the team member at the account level before adding them to the project. This change will significantly reduce the number of steps and the amount of time it takes to provide project access to a team member.

Of course, you can still limit their access to what sections they can see and what types of permissions they have with your content. We’ve also made sure that account admins are notified any time a new member is added to the project.

As we mentioned earlier, part of the challenge of managing a regulatory submission is overseeing the contributions made by your cross-functional teams. These cross-functional department members consistently share documents, reports, images, and tables to upload into your submission. Our latest product update streamlines and simplifies the entire file management process.

Now, files can be found on their own screen within the project management dashboard. Within that screen, you can view every file that has been uploaded including document type and upload date. It also shows if a newer version has replaced a previously uploaded file. We’ve also added new filters for users to find the desired file much quicker.

Let’s Review

This product update is the latest in our unwavering commitment to helping regulatory specialists create an error-free regulatory submission in less time and with fewer headaches. We have revamped the user interface that makes authoring sections easier and more efficient. We also transformed our project management dashboard to include multiple tabs that make finding key information easier. Lastly, this update makes it easier to track file uploads, invite new team members, and respond to Additional Information requests from regulatory authorities by duplicating a project.

About Essenvia

Essenvia is a regulatory lifecycle management tool designed to help you optimize the entire regulatory operations process. Our solutions include an innovative approach to building your pre-market submissions like 510(k) and MDR as well as post-market submissions like Regulatory Change Assessment and Post Market Surveillance. Essenvia is designed to reduce errors, streamline processes, and guarantee faster regulatory clearance for your medical device.

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