Device Development Process

The FDA defines a medical device as "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 any of it's 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."

The Center for Devices and Radiological Health (CDRH) is a center within the Food and Drug Administration (FDA) that regulates and approves medical devices sold in the United States along with medical and non-medical radiation emitting products.  Devices containing drugs, biologics, or radiating emitting devices may also fall under the jurisdiction of one of the other FDA centers and be subject to additional regulations.

Medical devices distributed in the United States must comply with the following regulatory requirements: Establishment Registration; Medical Device Listing; Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA); Investigational Device Exemption (IDE) for studies; Quality Systems Regulation; Labeling Requirements; Medical Device Reporting (MDR).

Device development regulations are filled with exceptions, exemptions, and special classifications.  For example, devices being tested to determine consumer preference can be exempt if they are not intended to establish safety or effectiveness.  Veterinary and laboratory animal research devices are exempt when used solely for those purposes.   Humanitarian Device Exemptions (HDEs) can be granted if a device is being used in a condition that affects less than 4,000 people a year in the U.S. Expanded access can be granted for compassionate use, treatment use, continued access, or emergency use.

If a device manufacturer does not have a device that is exempt from the regulatory requirements they either have to complete a Pre-Market Notification 510(k) or a Premarket Approval (PMA).  If the 510(k) or PMA requires clinical data to support the application an Investigational Device Exemption (IDE) may also need to be filed.