FDA Changes Medical Devices CGMP Rules

In the Federal Register of 25 August 2008, the FDA announced changes to the Code of Federal Regulations (CFR). These will affect the Parts 16, 610, 640, 814, 822 and 860. While number 16 regards administrative practices and the 600s refer to biologics, the 800s amend the corresponding rules for medical devices. All regulations came into force the very same day.

The corresponding changes are intended as amendments and as such exclusively to be read in combination with the original text of the concerned CFR passages.

21 CFR 812.20 ("Application") refers to investigational device exemptions. Special information that has already been submitted does not have to be submitted again, but could be referenced. The amendments concerning Part 814 ("Premarket Approval of Medical Devices") focus on the paragraphs § 814.42 ("Filling a PMA"), § 814.100 ("Purpose and Scope") and § 814.104 ("Original Applications"). The essential complements consist in the extension to other centres than the Center for Devices and Radiological Health (CDRH), which is competent for medical devices. Should this be a hint at a stronger reference to "combination products"?

Part 822 deals with "postmarket surveillance", especially § 822.8 regarding the "postmarket surveillance plan". For medical devices regulated by the CDRH, in the future, 3 copies of the marketing authorisation are required within the framework of postmarket surveillance. Another amendment was that of Part 860 ("Medical Device Classification Procedures") with regard to § 860.7 ("Determination of safety and effectiveness") and § 860.123 ("Reclassification petition: Content and form"). In both cases, the individual requirements have been described in more detail, e. g. regarding new addressees.

The excerpt from the Federal Register can be found here.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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