lunes, 19 de marzo de 2018

REMINDER: Webinar - Combination Product Updates for “Acceptance and Filing Reviews for Premarket Approval Applications” and “Refuse to Accept Policy for 510(k)s”– March 20, 2018

On January 30, 2018, the FDA posted the updated final guidance documents:
These guidance documents explain the procedures and criteria the FDA intends to use in accepting or refusing a 510(k) or PMA submission. It includes checklists to identify the necessary elements and contents of a complete application. The updates address provisions in the 21st Century Cures Act (Cures Act), which was enacted on December 13, 2016.  The Cures Act amended section 503(g) of the Food, Drug and Cosmetic Act (FD&C Act) and applies certain drug provisions to device-led combination products.

On Tuesday, March 20, 2018, the FDA will host a webinar for manufacturers and others interested in learning more about the statutory changes related to combination products included in these guidances. FDA employees are welcome to participate in this webinar and may join in listen-only mode.

Webinar Details:

No registration is required.

  • Date: Tuesday, March 20, 2018
  • Time: 3 – 4:30 PM EST (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar)
  • To hear the presentation and ask questions:
  • Dial: 800-369-2040, International Callers Dial: 1-773-756-4813; Conference Number: PWXW6784811; Passcode: 1397061
  • To view the slide presentation during the webinar:
Following the webinar, a transcript, audio recording, and slides will be available at: The slide presentation will also be available at this site on the morning of the webinar.
As always, we appreciate your feedback; following the conclusion of the webinar, please complete a short survey about your FDA CDRH webinar experience. The survey link will be provided at the conclusion of the webinar.

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