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Guide to Inspections of Medical Device Manufacturers
December 1997

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  1. MDR Regulations - 21 CFR 803

    Remember when reviewing complaints to check for MDR reportable events. The Compliance Program requires an MDR inspection every time a GMP inspection is made of a medical device manufacturer. CDRH has included in the Compliance Program guidance for evaluating a manufacturer's compliance with the requirements of the revised (July 31, 1996) MDR regulation.

    The Establishment Inspection Report (EIR) must state that complaints, service records, etc. were reviewed for MDR reportability, that the firm's MDR procedures were reviewed and whether the firm was found to be in compliance with the MDR regulations. Observations related to the MDR regulations should be noted on the FDA 483 or discussed with management as appropriate.

    For further guidance on MDRs, see CP7382.830 and the guidance manual dated March 1997 issued by CDRH/Division of Small Manufacturer's Assistance (DSMA), "Medical Device Reporting for Manufacturers" .

  2. Establish and Maintain Procedures for Performing and Verifying that the Servicing Meets Specified Requirements, and for Analyzing Reports - 21 CFR 820.200(a) and (b)

    Manufacturers must analyze service reports, and where necessary, with appropriate statistical methodology in accordance with 21 CFR 820.100 (e.g. frequency distribution charts, Pareto analysis or other analytical methods). Documentation for this should be established under corrective and preventive action in accordance with section 21 CFR 820.100. A determination should be made as to whether the firm has an adequate system in place for screening repair and service requests to assure whether any of these meet the definition of a complaint. Service reports initiated as a result of a complaint must be cross-referenced in the complaint handling system. NOTE, every service report is not necessarily a complaint.

    Determining MDR-Reportable Service Reports - 21 CFR 820.200(c)

    Remember when reviewing service records to also check for MDR reportable events. Any service report that represents an event which must be reported to FDA under part 803 or 804 of the MDR regulation must automatically be considered a complaint and receive appropriate follow-up under the requirements of section 21 CFR 820.198.

  3. Corrective and Preventive Actions - 21 CFR 820.100


    It should be remembered the complaint section of the QS/GMP regulation (21 CFR 820.198(b)) refers to all complaints, whether or not a complaint represents a possible failure of the device. 21 CFR 820.198(c) requires all possible failures of devices to be investigated to determine whether the failure can be confirmed and/or cause of the failure can be determined. Once the failure is confirmed as an actual failure of the device, the Corrective and Preventive Actions section of the QS/GMP Regulation (21 CFR 820.100) takes effect. It is important to remember that at times trending or continual monitoring of complaints for specific failures can be a corrective and preventive action. This is especially true when a firm cannot determine the cause of the failure.

    A determination must be made as to whether the firm has established procedures for implementing corrective and preventive action.

    Determine if the firm screens repair and service requests and conducts trend analyses to identify premature failures within the warranty period, and to detect problems with particular components, subassemblies, or design.

    Any product failures within the warranty period are likely to be product design or GMP related. For example

    1. Product design related issues may be those related to electrical safety, EMC, consistent user error or robustness of the product to packing, handling, storage and shipping.
    2. GMP related issues are validation of assembling processes, screening and receiving, and in-process or finished device acceptance.

    Review records for investigations to identify common failure trends (e.g., by component, subassembly, manufacturing error, or employee training). Compare these trends with corrective action documentation.

    These common failure trends may provide clues to which areas or products to focus on during the inspection.

    Your inspection should include detailed inspection of documents maintained under the requirements of 21 CFR 820.100, Corrective and Preventive Actions. In particular, you should focus on reliability issues that have not been documented for corrective and preventive actions. The continued distribution of devices with a known problem should be noted on the FDA 483 (or DCIS report for design problems.)


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