FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform

April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for new devices and diagnostic tests. But last week, the agency extended the comment deadline 30 days to May 22. Here’s a quick review of the proposal.

The Proposed New Pathway
Under current FDA rules, device and diagnostic test manufacturers can use the 510(k) pathway to secure expedited approval for new products that they can show are substantially equivalent to products that were grandfathered in when Congress created the pathway back in 1976. So, it goes without saying that the pathway is antiquated and in desperate need of an overhaul. Last February, the FDA floated a proposal to create a new “Safety and Performance Based Pathway” that would base new product approvals on consensus standards rather than direct predicate comparisons with previously approved devices.

The FDA’s 5 Questions
In its notice requesting comments on the new proposal, the FDA posed a series of six questions:

1. Should the FDA publicize a list of devices or manufacturers currently on the market that rely on predicate technology for more than a specific number of years in an attempt to use embarrassment as motivation for modernization?
2. If so, what number of years should that be?
3. Should the FDA consider using other criteria to inform our point of reference?
4. Are there other actions FDA should take to promote the use of more modern predicates?
5. Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?

(For more on the FDA proposal and its impact on labs, see NIR March 11, 2019.)