FDA Publishes First Performance Metrics for Third Party 510(k) Reviews

The US Food and Drug Administration (FDA) on Friday published the first of its quarterly performance reports for accredited third party reviewers for certain medical device submissions.

Background

FDA's third party accredited persons program was created by the 1997 FDA Modernization Act (FDAMA) as a means of making the review process for certain low-risk devices submitted under a 510(k) more timely and efficient.

Under the program, device makers can submit 510(k)s for eligible devices to accredited third parties that conduct the primary review of the submission before forwarding their recommendation to FDA, which makes a final determination on the recommendation within 30 days.

There are currently seven accredited third party reviewed under the program based in the US, China and Norway.

Performance Metrics

While FDA's third party accredited persons program has been operational for roughly two decades, the agency had not released performance data for individual third party reviewers until this year, after committing to do so in the recently reauthorized Medical Device User Fee Amendments (MDUFA IV).

However, under MDUFA IV, FDA only agreed to publish performance data for third party reviewers that have completed a minimum of five reviews during the reporting period, which at the time of the agency's first report includes just one third party reviewer: Regulatory Technology Services (RTS).

The report itself features a box plot detailing the performance of the individual third party reviewers for six different metrics:

1. Initial third party review time
2. Third party hold time
3. Total third party review time
4. Total FDA review time
5. Total time to decision from FDA
6. Total time to decision from third party receipt

The report also provides data on the combined performance of all seven third party reviewers.

In total, FDA says there have been 18 third party 510(k) submissions in FY2018, eight of which have been completed and found substantially equivalent to a predicate device, and ten of which are still pending a final decision by FDA.

Of the ten pending decisions, nine are still within the 30-day window for FDA to issue a determination, while one has been pending for more than 30 days.

For the third party reviews themselves, FDA says the average total time to decision from the time a third party reviewer receives a submission to when FDA issues its final determination is 80 days, with an interquartile range of 52 to 94 days and the longest review taking 172 days.