What every medical device CEO needs to know

The FDA regulates over 1 trillion dollars' worth of products, which accounts for 22 cents of every dollar spent annually by American consumers.

The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.

820.5 Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part [820].

A device may be adulterated or misbranded for a number of reasons. A device may be adulterated, for example, if it was not manufactured in accordance with the required manufacturing standards ("good manufacturing practice"), FDCA § 501(h), 21 U.S.C. § 351(h); FDCA § 520(f), 21 U.S.C. § 360j(f); 21 C.F.R. part 820, or if it does not have the quality that it purports to possess, FDCA § 501(c), 21 U.S.C. § 351(c). Examples of causes of misbranding of a device include that its labeling is false or misleading, FDCA § 502(a), 21 U.S.C. § 352(a), or that it is an over-the-counter (i.e., non-prescription) device that does not bear adequate directions for the consumer to be able to use it, FDCA § 502(f), 21 U.S.C. § 352(f); 21 C.F.R. § 801.109. A device may also be adulterated or misbranded because it lacks requisite FDA clearance or approval. See FDCA §§ 501(f), 502(o), 21 U.S.C. §§ 351(f), 352(o).

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