By: Alberto Gutierrez, Ph.D.

In the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification (510(k)) submissions sooner than expected. This will be due to a six-month pilot program called Triage, launched recently by FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, a part of the Center for Devices and Radiological Health (CDRH).

The goal of Triage is to improve efficiencies in the review process. Reviewers will focus more of their time and attention on higher-risk and novel devices, like companion diagnostics, and less time on devices that are lower-risk and have well-known and well-understood safety and effectiveness profiles. 

As the name “Triage” suggests, when certain 510(k) submissions are submitted, reviewers will make an assessment of the level of resources needed to complete a review, based on a quick assessment of the submission’s content and completeness. High-quality submissions that meet certain criteria and contain all of the information needed for a substantial equivalence evaluation will be slated for a 30-day Quick Review. Those 510(k) submissions not meeting these criteria would receive the standard review (generally 90 days) consistent with user fee performance goals.

To qualify for a 30-day Quick Review, the 510(k) submission must:

• be well-written, organized and contain all expected data and information to support substantial equivalence claims;
• be for a device that is well-known to FDA;
• be for a device that does not have existing or unresolved postmarket issues;
• not require an extensive review by a subject matter expert other than the reviewer assigned to the submission; and
• contain a 510(k) Summary, which is a summary of the information used to support the substantial equivalence determination.

And even with time saved, the Triage pilot program will preserve the quality and transparency of the normal 510(k) review process. Reviewers will still assess the same elements as they would in a standard review, but instead will accomplish it within 30 days. If the device is found to be substantially equivalent to a legally marketed predicate device, the 510(k) Summary will be posted online, allowing the public to see FDA’s basis for the substantial equivalence determination.

At the end of six months, FDA plans to evaluate and refine the program. The evaluation will provide us with some simple metrics on 510(k) review times and use of resources, but the impact, we hope, will go beyond the numbers.

For manufacturers, healthcare practitioners and patients, faster reviews will mean some products will be available sooner. For FDA staff, the time saved by using Quick Review can be devoted to reviewing submissions for higher-risk devices and novel technologies and to expanding their knowledge and expertise in new and emerging science. Depending on the pilot’s outcome, CDRH may consider expanding the Triage program to other device types besides in vitro diagnostics and radiology products.

Facilitating access to safe and effective devices is a goal shared by FDA, manufacturers, the healthcare community, and the public. We’re optimistic that our innovative Triage pilot program can help us meet that goal and that industry will see the possibility of a 30-day review as additional incentive to submit high quality 510(k) submissions.

Alberto Gutierrez, Ph.D., is Director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, a part of the Center for Devices and Radiological Health