FDA Further Outlines Plans to Strengthen and Modernize 510(k) Pathway
On January 22, 2019, the U.S. Food and Drug Administration (FDA or the Agency) detailed in a Final Guidance document the steps it is taking to strengthen and modernize its premarket notification (i.e., 510(k)) pathway for medical devices.
FDA's announcement is a continuation of its policy changes affecting regulated medical devices. In April 2018, the Agency issued its Medical Device Safety Action Plan, in which FDA committed to strengthening and modernizing its 510(k) program. And in November 2018, as discussed previously, FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), issued a joint statement in which Drs. Gottlieb and Shuren outlined a multi-faceted proposal that would, among other things, involve:
- Public disclosure of the use of predicate devices more than 10 years old;
- Potential sun setting older predicates and promoting the use of modern predicate devices; and
- Establishment of an alternative "safety and performance based" 510(k) pathway (perhaps the abbreviated 510(k) pathway by a different name).
Safety and Performance Based Pathway; Issuance of Final Guidance
Going further than its previous April and November 2018 announcements, the Agency last week posted on its website final guidance establishing the framework for the Safety and Performance Based Pathway (Final Guidance). The Final Guidance name changed from the draft guidance, which was entitled "Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria." Per the Agency, it changed the title to "reflect FDA's focus on advancing improved safety and performance of new products."
As with any guidance document it issued, the Final Guidance is merely the Agency’s current thinking with respect to this issue. It is not binding nor does it represent the only approach a party may use to achieve its desired outcome. An alternative approach is permitted so long as the approach satisfies the requirements of applicable laws and regulations.
In its announcement and in the Final Guidance, the Agency outlined the differences between the abbreviated 510(k) program and the safety and performance based 510(k) pathway. The former is based on conformity to FDA-recognized consensus standards. Under the latter, a manufacturer would have the option to demonstrate aspects of substantial equivalence by showing that a new device meets Agency-identified performance criteria that reflect current technological principles and the safety and performance of modern predicate devices.
Importantly, FDA plans to identify the types of devices and the applicable performance criteria for the safety and performance based pathway through future guidance. Once the Agency publishes its first device-specific guidance document, FDA will communicate with stakeholders and hold a webinar to further explain how the pathway will be implemented. The Agency is encouraging stakeholders to provide their suggestions and comments on this proposal using docket number FDA-2018-D-1387.
Establishment of Modern Predicate Device Docket
Beyond issuing the Final Guidance discussed above, FDA has issued a notice and opened a docket requesting comments regarding approaches to encourage device sponsors to offer patients devices with the latest improvements and advances. The Agency is considering posting on its website a list of FDA-cleared devices that demonstrated substantial equivalence to older predicate devices. With respect to this issue, the Agency is requesting feedback on the following questions:
- Should FDA make public a list of devices or manufacturers who make technologies that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?
- Should the Agency consider using other criteria to inform its point of reference?
- Are there other actions FDA should take to promote the use of more modern predicates?
- Should the Agency consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?
FDA is requesting that comments be submitted to docket number FDA-2018-N-4751 by April 22, 2019.
The medical device industry had already stated its opposition to potential sun setting of older predicate devices. We expect similar concerns to be raised in response to the Agency’s Final Guidance, as FDA’s potential phasing out of older predicates could have a significant impact on industry, physician entrepreneurs, hospitals, and academic medical centers. If, for example, parties are no longer able to rely on certain predicates, they would no longer be able to market their devices unless they found a more recent predicate, or unless they obtained another clearance or approval. This could produce gaps in the marketplace that affect patient outcomes and could disrupt provider preferences with respect to specific medical devices.
If you have questions regarding an issue raised in this alert or the Final Guidance, or if you are interested in submitting comments to either or both of the above-referenced dockets, please contact the authors or the attorney at the Firm with whom you are regularly in contact.