FDA 510(k) Process

FDA to Leverage Standards with New 510(k) Premarket Clearance Process One of the many important tasks handled by the Food and Drug Administration is the approval of new medical devices and products. Approval of a new device is granted only after a thorough review of the device by the FDA to ensure the safety and efficacy of the device. A significant part of the review process requires proof that organic debris and biofilm can be removed from the device on every reprocessing cycle. To start the review process, a 510(k) must be submitted to the FDA by the person or firm that wants to market the new device. Submission of a 510(k) for a new medical device or product to the FDA is a lengthy, time-consuming and expensive process. “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).”¹ The FDA’s current 510(k) program for new product approval is now well over 40 years old. When initially implemented in 1976 by an act of Congress, all products and devices that were already in use were ‘grandfathered in’ and assumed to be safe. When the program was first implemented, there few new devices being brought to market and the 510(k) program which called for the manufacturer to prove ‘substantial equivalency’ was deemed sufficient to provide patient safety. Regretfully, the ability to thoroughly remove organic debris and biofilm from a device during reprocessing wasn’t even considered in those days. For the past several years the FDA has been working on a program to update the old 510(k) approval process. The FDA recently issued final guidance for a program intended to modernize the 510(k) premarket clearance process by shifting away from the longstanding practice of comparing new devices to previous iterations, called predicate devices. Under the new, optional Safety and Performance Based Pathway, medical device manufacturers and individuals will compare the performance of some moderate-risk medical devices to FDA-identified criteria, including FDA-recognized consensus standards. ² “We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices. In short, we believe that it’s time to fundamentally modernize an approach first adopted in 1976, when Congress considered the vast diversity of devices that would become subject to the FDA’s regulatory oversight and established many of the predicate devices that served as the basis for 510(k) clearances during the last 40 years.” ³ According to FDA Commissioner Scott Gottlieb and Jeff Shuren, the newly proposed Safety and Performance Based Pathway will encourage “greater market competition to develop safer devices” and “ensure that the performance characteristics of new devices are evaluated against a set of objective, transparent, and well-validated safety and performance metrics.” ⁴ “The benefit of this approach is that the pathway will benchmark modern technology against modern standards while, at the same time, offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market, and thereby ensure patients have timely access to beneficial products.” ⁵ The new Safety and Performance Based Pathway can be used by individuals and companies seeking new device approval when the FDA has determined that: The new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate, and the predicate is within the scope of the list of eligible device types. Additionally, the performance criteria must align with the performance of one or more legally marketed devices of the same type as the new device. Finally, the new device meets all FDA-identified performance criteria, including the validation of the cleaning instructions for use (IFUs). The amount and type of information needed to demonstrate substantial equivalence under the Safety and Performance Based Pathway will depend on the source of the performance criteria and testing methods, according to the FDA. Supporting documentation may include a Declaration of Conformity to an FDA-recognized standard, testing protocols, a summary of the data, and/or underlying data. ⁶ So what does this new program mean for you, your staff and your healthcare facility? It means that more new technology will be introduced faster to help improve patient care and outcomes. Additionally, it will help ensure that new reusable medical devices can be safely reprocessed because the IFUs will have been validated as part of the FDA’s approval process.

1. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
2. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM604195.pdf
3. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626572.htm
4. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629686.htm
5. Cite.
6. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM604195.pdf