In late 2019, the FDA introduced a new Safety and Performance Based Pathway which can potentially speed up the preparation and review process for certain submitters of pre-market notification medical device submissions. This optional pathway was created by the FDA to assist with well understood device types, in which a submitter references device specific guidance’s detailing the appropriate testing standards, as well as defined performance criteria to demonstrate the device is as safe and effective as a legally marketed device.
Under the approach expanded in the Safety and Performance Based Pathway guidance, a submitter could satisfy the requirement to compare its device with a legally marketed device by, among other things, demonstrating that the device’s performance meets established performance criteria. These performance criteria are derived from FDA-recognized consensus standards, FDA guidance’s, scientific literature, special controls and historical 510(k) submission data. In all 510(k) submissions performance data is critical to proving a state of substantial equivalence to a predicate device and is often the most time consuming and complicated part of crafting a premarket regulatory submission.
The concept of this new pathway is to create clearly defined guidance’s for well-known products that outline the requirements and acceptance standards so that the FDA receives the most accurate data to simplify the review and hopefully lead to an expedited determination. It is critical to understand that these are only for appropriate devices with the same product code and indications for use, for instance. Additionally, the guidance’s list devices that might be in the same family of products, but are excluded from the pathway for other determinations by the FDA.
As of August 2020, FDA published two final guidance’s and four draft guidance’s for well-known products that meets the criteria for the new medical device pathway. FDA intends to publish more guidance’s over time so that additional devices can be categorized into this format.
Currently, the two final guidance’s that identify performance criteria and testing methodologies for these device types:
The FDA issued four draft guidance’s identifying performance criteria and testing methodologies for the following device types.
- Spinal Plating Systems
- Orthopedic Non-Spinal Metallic Bone Screws and Washers
- Magnetic Resonance Coils
- Soft (Hydrophilic) Daily Wear Contact Lenses
Once these guidance’s are finalized, submitters will have the option to use the safety and performance-based pathway for these device types.
It is important to note that the majority of the other aspects of the pathway are very similar to the current pre-market submissions; including the structure and headings of the submission, user fees remain the same as a 510(k) submission, standard review time is still 90 days and eCopies are still required.
The addition of the Safety and Performance Based Pathway is another step in the process of improving the premarket medical device submission for both industry and regulators. If you or your firm has any regulatory needs or questions regarding regulatory submission, please send us an email at firstname.lastname@example.org for a rapid response and quote for the required services.
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway. Safety and Performance Based Pathway. U.S. Food and Drug Administration. Published September 20, 2020.