Medical Device Refurbishment and FDA

Originally Published MX July/August 2002

GOVERNMENTAL & LEGAL AFFAIRS

Medical Device Refurbishment and FDA

In 1994, FDA undertook to review the activities of medical device rebuilders, refurbishers, and remarketers, with an eye toward possibly revising its 1987 compliance policy guide. In 1995, it began a dialogue about this issue with a trade association constituted primarily of remarketers of used medical imaging devices. Then, in October 1996, the agency announced changes to its good manufacturing practices (GMP) regulation, which was renamed the quality system regulation (QSR) and included new sections dealing with repairs to medical devices.

While the principal reason for the revised 1996 QSR was the harmonization of U.S. manufacturing standards with the ISO 9001 quality systems standard compiled by the International Organization for Standardization (ISO), the new regulation made medical device remanufacturers subject to the same manufacturing practices as original equipment manufacturers. Owing to intense internal disagreement among members of FDA’s