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Compliance In Focus
Posted by John Lehmann on Tue, Oct 23, 2012

New FDA Program: What Does This Mean for 510(k) Submissions?

New FDA ProgramIn an effort to promote innovation while protecting the population at large, FDA has been on a path to revise the existing regulatory pathway surrounding the 510(k) process for medical devices for several years. This continues to be an area of many questions and considerations. In fact, we’ve devoted a whitepaper to these issues to help researchers understand the 510(k). Recently FDA released a Draft Guidance on the eCopy Program for Medical Device Submissions. While this system is currently voluntary, the draft guidance gives industry an idea of what might be in store for device submissions.

The draft guidance describes eCopy as “an exact duplicate of the paper submission, created and submitted on a compact disc (CD), digital video disc (DVD), or in another electronic media format that FDA has agreed to accept, accompanied by a copy of the signed cover letter and the complete original paper submission.”

As noted in a recent news-release on Regulatory Focus, the guidance lists explicit details about:

  • How to submit an eCopy
  • Steps to assure that a submission is up to FDA standards
  • How to submit to different FDA centers
  • Common mistakes made in submissions and
  • How to avoid the common mistakes made in submissions

How will this effect the device submission process and 510(k)? According to another recent guidance released by FDA, “Most 510(k) submissions will be subject to a user fee as described in the guidance and all 510(k)s will be subject to the requirement for an eCopy. Submitters should note that 510(k) submissions will not be processed and distributed to the appropriate Division for review without confirmation of user fee payment and a validated eCopy.”

It plainly states in the “Actions on Premarket Notification 510(k) Submissions: Effect on FDA Review Clock and Goals” Guidance, 510(k)s need a valid eCopy in order to initiate review.

Do you think this is just an administrative hurdle to add to the 510(k) submission process? Or, do you think this will help streamline reviews? Voice your opinion below.

Photo Credit: highersights

Register for IMARC & ImageIQ's Complimentary Webinar:  "Imaging in Clinical Trials – Unique Compliance Challenges" Wednesday, November 7, 2012 - 11am EST

Topics: Medical Device Submissions, FDA, 510(k)


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