<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=213807269037206&amp;ev=PageView&amp;noscript=1">
Compliance In Focus
Posted by John Lehmann on Mon, Apr 23, 2012

FDA & 510(k): Could a 30-Day Review be a Reality?

A new pilot program that started this month may bring about noticeable changes in 510(k)FDA Faster Reviews (4) reviews. Starting in April 2012 and running until October 2012 the FDA is testing The Triage Pilot Program. According to the website, the objective is to reduce the review time of Traditional 510(k) applications that are of good quality as incentive to sponsors to submit such applications.

What exactly is the incentive? Well, how about a review that will clear within 30 days! As MassDevice points out, these shorter reviews will have to qualify for the “Quick Review Tier” with the submission:

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

 Just how does the Triage program plan to turn around reviews so quickly? The FDA has a really great flowchart on their website to show the “triage” of submissions. Alberto Gutierrez, Ph.D., Director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, a part of the CDRH describes the process well by explaining, “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.”

What are your thoughts on this triage program for 510(k)? Do you think a 30-day review could be a reality? Share your thoughts with us!

Photo Credit: Zanthia

Topics: FDA, 510(k)


Posts by Topic: