FDA Estimates QSRs Cost Manufacturers 3 Million Hours

The 8,963 domestic device manufacturers registered with the Center for Devices and Radiological Health spend more than 3 million hours annually on efforts to comply with the recordkeeping requirements of quality system regulations (QSRs), according to the FDA.

The agency also estimated that 650 new device firms spent 143,052 hours annually on one-time startup processes, such as record development, required under QSRs.

The FDA estimated that 40 percent of the roughly 3 million hours expended on compliance involve manufacturing specifications, process controls and device history records.

Requirements for component and acceptance activities account for 20 percent of the 3 million hours, with 25 percent associated with equipment, device master records, quality system records, complaint investigations, labeling/packaging and reprocessing/investigating product nonconformance.

Documentation for quality audits, traceability, handling, distribution, statistical and other recordkeeping requirements accounts for 15 percent of the time burden.

The agency released the data in its request for comments on recordkeeping requirements related to medical device QSRs. Comments are due Sept. 7. More information can be viewed at www.fda.gov/OHRMS/
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