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Compliance In Focus
Posted by John Lehmann on Wed, Nov 14, 2012

FDA’s 510(k) - A BIG Thumbs Down?

A recent survey of almost 200 med-tech executives measured the perceptions of the 510(k)FDA's 510(k) - a Big Thumbs Down pathway, FDA’s performance, and FDA’s consistency. While FDA continues to try and clarify the pathway for approval, there continues to be much controversy and confusion of the direction of the program. This is in stark contrast to FDA’s goal of 510(k) which is to provide predictability for companies seeking lower-risk device approval. So, what did the recent survey show?

The Medtech Resource Alliance’s evaluation shows that the med-tech’s current satisfaction with 510(k) and FDA’s management of the review process is lower then expected at 30%. Difficulties can be defined under three main areas of concern:

  • Quality of decisions
    • Failures in understanding the scientific, legal or regulatory issues
  • Transparency of decision making process
    • FDA conclusions did no give enough detail and companies are challenged to understand the basis for reviewers’ decisions
  • Time taken to reach a decision or resolution
    • Lack of clarity in requests for additional information introduced unnecessary delay and prolonged the time to resolution

Since the initial draft guidance was released, critics have argued that these proposed changes could negatively impact industry, raising the R&D costs to bring a non-significant risk device to market and potentially pushing jobs out of the US as companies strategically look for less cumbersome routes of approval.

While more clarity is forthcoming regarding 510(k) submissions, it is important to understand FDA’s current thinking on the process and status of the pathway. Checkout IMARC’s whitepaper for a timeline of important dates as it relates to the medical device approval framework.

Do agree with the results of the study? Do you feel these are the three key areas FDA needs to improve? We are curious as to the general consensus out there, post your thoughts below.

Photo Credit: otherthings


Topics: The Medtech Resource Alliance, FDA, 510(k)


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