Inspections, Compliance, Enforcement, and Criminal Investigations
Guide to Inspections of Medical Device Manufacturers
The medical device Quality System/GMP Regulation (QS/GMP) is an umbrella GMP intended to cover all medical devices from dental resins to magnetic resonance imaging devices to In Vitro Diagnostics (IVDs) to some engineered tissues. The Quality System Regulation specifies general objectives (e.g. calibrated equipment, training, management responsibility, process and design controls) rather than methods, since one method would not be applicable to all manufacturers. In most cases, it is left to the manufacturer to determine the best method to attain these objectives.
Manufacturers should be able to defend their methods, procedures, etc. as being appropriate and adequate. Not all sections of the QS/GMP will apply to each manufacturer. Manufacturers must determine what sections of the QS/GMP apply to their specific products and operations. When a manufacturer decides that a section of the QS/GMP qualified by the term "where appropriate" does not apply, they are required to document their justification.
Investigators should use good judgement when conducting a medical device QS/GMP inspection. They need to:
a. assess whether the manufacturer has the required written procedures,
b. is following those procedures and,
c. has documented evidence that those procedures, methods, etc. are adequate given:
1. the size of the firm,
2. the complexity of the device(s) being produced and,
3. the relative risk to users if the device does not meet its finished product specifications or the manufacturing facility is not operating in a state of control.
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. This data assists the investigator in determining possible problem areas in the manufacture, or design, of the device, or lot or batch specific issues. This data should be used to focus the inspection.
The firm's reported registration and listing data should be verified during any GMP inspection to assure there have been no changes and the registration and listing data was accurately reported. Changes or inaccuracies should be immediately reported to the district medical device registration and listing monitor. See also Field Management Directive (FMD) 92.
510(k) and PMA data assists the Investigator in determining what devices the firm is manufacturing and whether any new devices have been designed or changed since the last inspection. This data is useful in focusing the inspection on new or changed devices as well as devices that are higher risk devices, i.e. class II or III versus class I.