SPECIALTY RX FACTS

3Aug/110

FDA Posts New Draft Document on 501 (k) Premarket Notifications

FDA developed a draft document to provide guidance to manufacturers on when to submit a premarket notification submission (510(k)) for changes or modifications made to that manufacturer’s1 previously cleared medical device. The underlying principles that FDA uses to determine when a 510(k) is necessary for a modified device are explained, and examples are provided for additional clarity. When final, this guidance will supersede the 1997 version of the guidance document..

While the suggestions are modest in nature we suggest you review this document for importance to your organization.  D2 has a broad network of specialists focus on the commercialization of devices.

For a full review of the draft document please click on http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265274.htm#1

 

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