Mike on Medtech: The 'New' Alternative 510k

Mike on Medtech: The 'New' Alternative 510k

Mike Drues and Sean Fenske discuss a recently announced 510(k) pathway that actually resembles an already existing option.

By Sean Fenske, Editor01.29.18
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recently announced alternative 510(k) pathway that attempts to trim the time to clearance for medical device manufacturers. Is it, however, an option that already exists packaged in a new wrapper or is it a truly new option put forth by Gottlieb's FDA? Listen to this episode and then see what you think. Specifically, the following questions and topics are addressed in this discussion:

  • What is the “new” alternative 510(k)?
  • What are the types of 510ks and how do they differ?
  • What does “least burdensome” mean?
  • Does abbreviated 510k mean less time or less work for the company?
  • How does this compare to what’s available in the EU?
  • Which is a better system between the new MDR and this 510k?
  • What are the lessons to be learned/advice moving forward?

For Further Reference
Check out the following links for more information about this topic.
New Steps to Facilitate Beneficial Medical Device Innovation
The Least Burdensome Provisions [PDF]
What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More

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 this "new" option for a 510(k) clearance, 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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