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 is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?

Manage GSPR (General Safety And Performance Requirements) in Essenvia

What is GSPR?

The GSPR stands for General Safety and Performance Requirements as listed in Annex I of EU MDR 2017/745 and EU IVDR 2017/746. These requirements are similar to the Essential Requirements under MDD 93/42/EEC.

The GSPR has 23 requirements under EU MDR and 20 requirements under EU IVDR. The manufacturers who wish to get CE mark for their device have to establish conformity with these requirements and should provide sufficient evidence to demonstrate compliance with GSPR. GSPR is a core element to navigate CE marking for a device.

GSPR Chapters and Requirements Guide:

EU MDR 2017/745EU IVDR 2017/746
Chapter 1 – General requirements (1 to 9)Chapter 1 – General requirements (from 1 to 8)
Chapter 2 -Design and Manuf. (from 10 to 22)Chapter 2 – Performance, Design and Manuf. (from 9 to 19)
Chapter 3 –Labels and IFU (23)Chapter 3 – Labels and IFU (20)

Essential Requirements for EU MDD and EU IVDD

The Medical Device Directive (MDD) defines the “Essential Requirements”, as the requirements that every medical product has to fulfill, according to the scope they belong to. These essential requirements are described by Directive in Annex I, 93/42/EEC for EU MDD and 98/79/EEC for EU IVDD, and there are in total 13 requirements.

Essential Requirements Chapters and Requirements Guide:

Chapter 1 – General requirements (1 to 6)Chapter 1 –General requirements (from 1 to 5)
Chapter 2 -Design and Manuf. (from 7 to 13)Chapter 2 -Performance, Design and Manuf. (from 1 to 8)

Layout and Structure of the GSPR

The General Safety and Performance Requirements (GSPR) are divided into the following 3 chapters:

1. General requirements

  1. Intended purpose, safety of patients, users and other persons
  2. Reduction of risks
  3. Risk management system
  4. Risk control measures
  5. Risks related to use error
  6. Device performance shall not be adversely affected
  7. Device design, manufacture, packaging
  8. Risk reduction, acceptable risk-benefit ratio
  9. General safety requirements for devices without an intended medical purpose as described in in annex XVI

2. Requirements regarding design and manufacture

  1. Chemical, physical and biological properties
  2. Infection and microbial contamination
  3. Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances/substance combinations that are absorbed by or locally dispersed in the human body
  4. Devices incorporating materials of biological origin
  5. Construction of devices and interaction with their environment
  6. Devices with a diagnostic and measuring function
  7. Protection against radiation
  8. Electronic programmable systems – devices that incorporate electronic programmable systems and software that are devices in themselves
  9. Active devices and devices connected to them
  10. Particular requirements for active implantable devices
  11. Protection against mechanical and thermal risks
  12. Protection against the risks posed to the patient or user by devices supplying energy or substances
  13. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons

3. Requirements regarding the information supplied with the device

  1. Label and instructions for use

Essential Requirements vs GSPR

EU MDR and EU IVDR replace the EU MDD and EU IVDD for CE Mark in Europe. As shown in the table above, the Essential Requirements of the MDD are divided into 2 chapters with 13 items while MDR has 3 chapters with 23 items. This means that the changes from MDD have not only shifted quite a bit, but the scope of the details in requirements has also increased considerably with MDR.

To understand the extent of changes, items covering “Information provided by the manufacturer” from Chapter 2 in Essential Requirements have now been reorganized and incorporated into a new chapter 3 in GSPR.

Additional requirements and some administrative simplification for MDR come from the fact that the MDD has been combined with AIMDD (Active Implantable Medical Device Directive ER) and is now covered within GSPR Item 19. Further, in MDR’s GSPR a number of topics have been given greater emphasis or have been dealt with in more detail.

Besides expanding on some key aspects, several topics are newly incorporated in the requirements list of the GSPR. These include but are not limited to:

  • Requirements for devices that administer (GSPR 10.3/4) or contain drugs (GSPR Item 12)
  • Specific requirements for devices that contain tissues of human or animal origin (GSPR 13)
  • Requirements for disposal (GSPR 14.7/23.4)
  • Requirements for IT safety (GSPR 17.4)
  • Requirements for devices for use by lay persons (GSPR 22)
  • General requirements for labelling (GSPR 23)

Chapter 1 of GSPR

Chapter 1 in GSPR has many similarities with the MDD. However, there is a higher emphasis on usability and dependability along the product life cycle and the state of the art. Paragraphs 2 – 5 of Chapter 1 stress on risk management and the importance of medical devices. While paragraph 9 of Chapter 1 addresses devices without an intended medical purpose, the other paragraphs are very similar to the MDD and depict the “standard” requirements for every medical device.

Chapter 2 of GSPR

Key highlights as it pertains to changes from chapter 2 of GSPR are outlined below:

  • Paragraph 10 provides more details for the chemical, physical and biological properties, especially as it relates to handling of toxicity and specific substances
  • Paragraph 11 addresses requirements on infection and microbial contamination
  • The scope in paragraph 12 is extended to include substances absorbed or locally dispersed by the human body
  • Paragraph 13 now includes non-viable human tissue in the biological tissue category
  • New regulations have also been added for the interaction of medical devices with the environment (paragraph 14) and the compatibility with other devices
  • Network and cybersecurity has grown in importance within the global medical device diaspora and as such they are given high importance in the GSPR
  • Regulations for mechanical and thermal risks as well as risk reduction have also become more detailed

Chapter 3 of GSPR

In chapter 3 of GSPR, paragraph 23 “label and instructions for use” is covered in detail. In general, this chapter handles significantly more requirements, such as the format of the instructions for use, readability, comprehensibility, availability, and how this relates with laypersons in addition to professionals. This chapter also covers additional requirements that must be fulfilled for UDI labeling as well as devices containing human or animal tissue. The same applies to the labeling of sterile packaging or the indication of Carcinogenic Mutagenic and toxic to Reproduction (CMR) substances.

Transitioning from MDD to MDR and from IVDD to IVDR

From 26th May 2020 to 25th May 2024, CE mark certificates issued under the MDD, before the MDR fully applies, will be valid for up to 4 years. From 25th May 2022 to 25th May 2024, CE mark certificates issued under the IVDD before the IVDR fully applies may remain valid for up to 2 additional years. From 26th May 2024, all devices placed on the market must be in conformity with the MDR or IVDR.

Below is an infographic showing the transition timeline for medical device manufacturers in Europe:

MDR and IVDR Transition Timeline - GSPR (Essenvia)
MDR and IVDR Transition Timeline

Challenges of Maintaining GSPR

From a regulatory point of view, there has been no fundamental shift with the introduction of GSPR. It is still crucial that the safety and performance of medical devices are proven. This must be acceptable within the given clinical context and the manufacturer needs to ensure that the two components do not change significantly during the entire life cycle of the medical device. That is why a systematic risk management process is required, which must be updated constantly, even after the device is in the market.

Yet another challenge with the GSPR lies with the fact that many state-of-the-art requirements from harmonized standards have been incorporated directly into the MDR. However, no annex from the harmonized standards refers to the GSPR in the MDR currently. Meaning, manufacturers will still need to perform a careful gap analysis in order to establish the relation until no uniformity exists between the two.

The objective evidence that the GSPR is fulfilled is part of the Technical File. Also, during the selected conformity assessment procedure, it must be proven that the requirements in GSPR are fulfilled.

Best Practices to Streamline GSPR For your Medical Devices

GSPR as such is not just another document to be updated, but rather a critical artifact that guides the development process and decisions from the outset for a manufacturer. Therefore, medical device manufacturers should promptly prepare a new checklist for the General Safety and Performance Requirements (GSPR) according to Annex I of MDR and IVDR to ensure the new GSPR is implemented and complied timely.

Using the GSPR checklist is practical and ensures traceability and completeness, but the number of items and the ongoing process of adding references to evidence and methods of conformity in the form of searching and linking 100s of standards, evidence documents, or procedures especially as they change and evolve requires the constant upkeep and maintenance of GSPR for products.

Essenvia’s Regulatory Management tool allows you to easily maintain GSPR for your products and variants. It serves as a single source of truth that links to standards databases and evidence documents and reports within the platform, helping you easily cross-reference methods of conformity whether these are harmonized standards, procedures from your quality system, or testing reports. Easily create, publish and link new versions of the GSPR with the Technical File to maintain compliance with Annex I requirements for the MDR.Schedule a demo now to find out how Essenvia can help you with your regulatory submissions.

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