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Medical Device Registration and Listing Information Collection Under Review

Tuesday, October 27, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is requesting comments no later than Dec. 28 on the proposed extension of an information collection associated with the requirement for medical device establishment owners and operators to electronically submit establishment registration and device listing information.

The FDA states that complete and accurate registration and listing information is necessary to accomplish a number of statutory and regulatory objectives: (1) identification of establishments producing marketed medical devices, (2) identification of establishments producing a specific device when that device is in short supply or is needed for national emergency, (3) facilitation of recalls for devices marketed by owners and operators of device establishments, (4) identification and cataloguing of marketed devices, (5) administering post-marketing surveillance programs for devices, (6) identification of devices marketed in violation of the law, (7) identification and control of devices imported into the country from foreign establishments, (8) and scheduling and planning inspections of registered establishments.

Respondents to this information collection are owners or operators of establishments that engage in the manufacturing, preparation, propagation, compounding or processing of a device or devices who must register their establishments and submit listing information for each of their devices in commercial distribution. Notwithstanding certain exceptions, foreign device establishments that manufacture, prepare, propagate, compound or process a device that is imported or offered for import into the United States must also comply with the registration and listing requirements.

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