Is It a Medical Device?

Often, a company wonders if their product is a medical device and what that means for them. What are the FDA requirements for a particular product and how difficult will it be to get the FDA’s blessing?

To discover this information, the first step is to look at the encompassing definition of a medical device and question the product:

“A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or some other similar 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 any of 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.”

If any of this criteria applies, then it is time to search the CDHR Classification Database – it is likely that the device already exists in some shape or form in the database.

The Classification Database contains products that are already established as medical devices. The Classification Database also has useful information that one will need to know before marketing a device. For example, the database contains information on the device classification (i.e., Class I, Class II, or Class III).  Based on the device classification, certain levels of control are necessary to “provide reasonable assurance of [the device’s] safety and effectiveness.” Once the device classification is known, one can then have an idea of what regulations will need to be met.  Click hear to learn more about classifications and regulatory controls. Furthermore, the Classification Database, will provide information such as additional Special Control requirements, or whether the device requires a 510(k) for clearance or a PMA for approval.

If it is still not clear whether your product is a medical device, one can contact the FDA directly for an informal device determination. At the time of this writing, the email to contact FDA for device classification questions is DeviceDetermination@fda.hhs.gov.

Posted by Spencer Kimber