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.
FDA Regulatory Resources
- Center for Devices and Radiological Health (CDRH)
- CDRH Training and Education Resources
- CDRH Guidance Documents
- Device Advice
- Overview of Device Regulations
Devices are classified into three categories. Class I devices are low risk that require general controls to assure safety and effectiveness. Class II devices have moderate risk and are subject to both general and special controls. Class III devices are considered high risk and are subject to the highest level of regulatory requirements. The FDA has exempted almost all Class I devices with the exception of some listed as “Reserved Devices” from the PMA requirements. Some Class II devices are now exempt from Pre-market notification requirements due to the 1997 FDA Modernization Act. All Class III devices and those that do not meet the criteria for exemption or a 501(k) require a PMA.
Premarket Notification 510(k)
Devices that require a 510(k) cannot be commercially distributed until the FDA provides authorization. To receive authorization the manufacturer must demonstrate in the notification that the device is substantially equivalent to a predicate device. Predicate devices were on the market prior to May 28, 1976 or are currently on the market and do not require a Pre-market Application (PMA) to be completed.
A device is substantially equivalent if it has the same intended use as a predicate device and has the same technological characteristics or it has the same intended use as the predicate device and has different technological characteristics as a predicate but safety and effectiveness can be demonstrated.
If a device does not meet the criteria for a 510(k) then the manufacturer must submit a PMA application. If a clinical study is needed to support the application then an IDE may also be needed.
Investigational Device Exemption (IDE)
All clinical studies of devices must either have an approved IDE or be exempt from the regulations. The need for an Investigational Device Exemption (IDE) depends upon the level of risk associated with the use of the device. Devices are considered as either Significant Risk (SR) or Non-Significant Risk (NSR) devices.
Significant Risk (SR) Devices must follow full IDE requirements and require both FDA and IRB approval before studies can begin. Non-Significant Risk (NSR) devices are those that do not meet the criteria for significant risk. NSR devices have reduced regulatory requirements and only need IRB approval before studies can begin. IRB approval is considered equivalent to IDE approval for NSR device studies.
Premarket Approval (PMA)
The PMA is the most stringent application for devices and requires FDA approval before the manufacturer can market their device. In the PMA process the FDA is evaluating the scientific integrity of the clinical data being used to support the safety and efficacy of the device.