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Mike on Medtech: Pre-Sub with the FDA

Mike on Medtech: Pre-Sub with the FDA

Mike Drues and Sean Fenske discuss the benefits of the FDA's pre-submission review process for medical device manufacturers.

By Sean Fenske, Editor11.06.17
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of an FDA pre-sub (or pre-submission) prior to making a formal submission of a 510(k) or PMA to the agency. While a number of companies are taking advantage of this, as of right now, still free opportunity, many others are not. When submissions are being rejected at such high percentages (Mike offers the numbers in this podcast), it only makes sense for more companies to utilize this opportunity. Specifically, the following questions are addressed in this discussion:

  • What is a “pre-sub” and why should engineers need to care about it?
  • How early in the product development lifecycle should companies involve FDA?
  • What is a pre-sub lite?
  • What part in a pre-sub do engineers play, say with regard to testing matrix?
  • In September, we received guidance revisions with regard to the pre-sub. What was of significance in these revisions?

You can review the pre-sub guidance discussed during the podcast at the following URL:

Requests for Feedback on Medical Device Submissions: The Pre-Submission Program (CDRH, Sept. 2017)

Listen to the podcast streaming via the player below or you can download the MP3 file, load it onto your player of choice, and listen at your convenience.



Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about human factors in medical device development, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

Click here to review other episodes of Mike on Medtech.
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