US FDA Rules on Definitions of Device; Issues Revised Form for Reporting Adverse Events

The US FDA has issued final guidance clarifying how the agency interprets existing references to section 201(h) of the FD&C Act and how the agency intends to reference the definitions of “device” and “counterfeit device” in guidances, regulatory documents and other communications and documents for FDA staff, industry and other stakeholders going forward.

In addition, the FDA has revised the MedWatch Form 3500A used by importers, distributors, manufacturers and user facilities in the mandatory reporting of adverse events associated with the use of medical products, including medical devices.

Definition of device and counterfeit device

Generally, under the new guidance, the term “device” “means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory which is:

(A)  Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(B)  Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(C)  Intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).”

The term “counterfeit device” means “a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer or distributor.”

Revised MedWatch Form 3500A for reporting adverse events

The FDA issued a revised MedWatch Form 3500A used by importers, distributors, manufacturers and user facilities in the mandatory reporting of adverse events associated with the use of medical products, including medical devices.

The instructional guide for this submission form was also updated to clarify certain items and provide the current International Council for Harmonization (ICH) list and codes in appendix 1.