Twin Cites Chapter: Modifications 510(k): Deciding When to Submit for a Change to an Existing Device

2.0
RAC Credits
Thursday, 29 March 2018 (5:30 PM) - Thursday, 29 March 2018 (8:30 PM) (Central Time (US & Canada))
9750 Rockford Rd
Plymouth, Minnesota, USA, 55442-2893

Thursday, 29 March 2018
5:30-8:30 pm CDT
St. Cloud State University at Plymouth
9750 Rockford Road, Room #101
Plymouth, MN 55442
+1 763 496 6080


With innovation, change is a constant for medical devices. For devices brought to market by FDA’s premarket notification, or 510(k) process, careful evaluation of design and labeling changes are necessary to ensure these changes are submitted for 510(k) clearance before they are introduced. In late 2017, FDA released a revised, final guidance document related to evaluation of changes to existing devices. They also released a new, final guidance for evaluation of software changes. This presentation will provide an overview of these new guidance documents and share information on how to evaluate the changes to determine significance and how to document the regulatory evaluation of design changes.

This event is brought to you by the RAPS Twin Cities chapter and is intended to facilitate knowledge sharing and engagement among professionals in the local regulatory community. A light meal will be available for all attendees and RAC holders can claim two RAC recertification credits.


Featured speaker:
Adrienne Lenz, RAC, senior medical device regulation expert, Hyman, Phelps & McNamara P.C.


Registration Information:
RAPS Member: $30
List: $45

Call RAPS Customer Service at +1 301 770 2920 ext. 200 to learn about the special student registration rate.

Register