On January 30, 2018, the FDA posted the updated final guidance documents:
- Refuse to Accept Policy for 510(k)s
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
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.
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: https://www.mymeetings.com/nc/
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.