ANNOUNCING Final Guidance and FDA Webinar on Pre-Submission and Meetings

Recently, the Food and Drug Administration (FDA) issued a final guidance document, Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff (click this link to open the document). The Pre-Submission Program replaces and improves on the pre-IDE Program by expanding the program to include all types of feedback requests prior to any medical device submission.

The final guidance establishes a structured process for sponsors who submit pre-submission requests and for FDA staff and managers involved in their review. . It also explains, in detail, the Q-Submission structure the FDA is using to track feedback mechanisms and outlines each interaction type, including what is and is not tracked as a Q-Submission.

On February 26, 2014, the FDA will hold a webinar to help explain the guidance and to provide a forum for asking questions you may have regarding this guidance. Registration is not necessary.


Webinar Details:

Date: February 26, 2014

Time: 2:30 – 4:00 PM, Eastern Time. To ensure you are connected, please connect at 2:15 PM

To hear the presentation and ask questions:

Dial: 800-857-9818, passcode: CDRH

" target="_blank" title="Slide presentation for webinar">To view the slide presentation during the webinar:

Conference number: PW4390701

Passcode: CDRH

Participants can also join the event directly.

Following the conference, a transcript, audio recording and slides will be available.

Please Note: the slide presentation will also be available at this site on the morning of the webinar.