It’s a question on many IWLA members’ minds: Do I handle products considered “medical devices?” This is an even more important question now, as U.S. Rep. Fred Upton (R-MI), chairman of the House Energy and Commerce Committee is about to release a discussion draft on a legislative proposal to establish a national licensure program for 3PLs and wholesalers of medical devices.
Under the U.S. Food and Drug Administration Safety and Innovation Act, the Center for Devices and Radiological Health (CDRH) regulates manufacturers, repackagers, relabelers, and/or importers of medical devices sold in the United States. They also regulate radiation-emitting electronic products. The current law requires manufacturers to register the establishment, list the medical devices, and have proper labeling, inspections, incident reporting, and (based on the classification of the device) some are required to earn premarket notification/approval.
The FDA provides this high-level definition of a medical device: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them;
- 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
- 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 any of its primary intended purposes.”
Though helpful, the definition can lead to doubt in some instances. Is a toothbrush a medical device? Yes. Hearing aid? Yes. Dental floss? Yes. Hair brush? No.
FDA created a multi-tiered medical device classification system to assign pre-market regulatory controls: Classes I, II, and III. Classification of a device depends on the intended use and indications for use. Indications can be provided on labeling or verbally during a sale. Classification levels are also risk based (Class III as highest-risk) for the patient or the administrator.
All devices are subject to general controls; however, some devices may have exemptions to certain requirements. The FDA estimates 74 percent of Class I devices are exempt from premarket notifications.
What about a tissue? It depends on what kind of tissue. The FDA created a database to look up your products and assign a regulation number to it.
Do you store medical devices in your warehouse? IWLA is gauging the interest level of its membership in this space ahead of Rep. Upton’s proposal moving through the pipeline. Please let us know if this legislation affects you. Email us at mail@IWLA.com.