Pre-Inspectional Activity for Medical Device Manufacturers

Prior to the start of any medical device inspection, the factory jacket or establishment history of the firm should be reviewed. Special notice should be made of the previous inspectional findings and subsequent correspondence between the firm and FDA; of any MDR or consumer complaints where it was determined that follow-up would occur at the next inspection; and of any notifications of recalls since the last inspection.

The following on-line databases should be queried:

a. CDRH Information Retrieval System(CIRS) – for Medical Device Reporting (MDR) data (MAUDE), Registration and Listing data and 510(k) and PMA summary data (OSCAR);

b. MDRAPSY for MDR data prior to October 1996.

These databases are accessible to users with individual accounts. Accounts can be requested through the district or regional CIRS liaisons or from DEIO/Denise Dion (301) 827-5645 for MDRAPSY.

MDR data that is most useful in preparing for an inspection of a medical device manufacturer includes specific MDRs for that manufacturer (i.e. query by firm’s short name) for the time frame since the last inspection; or MDRs relative to the generic devices manufactured by that firm (i.e. query by product code) for some reasonable time frame.

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