Overview of Regulatory Requirements for Medical Devices

FDA Medical Device Regulation

FDA medical device regulations govern the manufacturing of medical devices. Medical device FDA regulation requires manufacturers to comply with all necessary principles before they are approved for sale.

According to FDA medical device regulations, Section 201(h) of the FD&C Act (21 USC 321(h)) provides that the term “device” refers to:

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is –

  • recognized in the official National Formulary, or the United States Pharmacopeia, 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 its primary intended purposes.”

Medical device FDA regulation stipulates that no medical device shall be adulterated or misbranded. Violations of these two requirements will result in a letter to the device manufacturing company issued by the Office of Compliance.

Medical device manufacturers must list their medical devices through electronic establishment registration when they plan to bring the device to market.

Device manufacturers, importers, and user facilities must report via the Medical Device Reporting program any time there is an adverse event related to use of a medical device. Care must be exercised when sharing sensitive information; it should be encrypted and transmitted securely, especially when protected health information is enclosed.

Such mandatory reporting is important because it allows the FDA to track problematic and potentially dangerous devices, and to protect the public.


Medical Device Classifications

The FDA classifies medical devices in three classes:

Class I: Basic devices that are associated with low level of risk, such as a reflex hammer or bandage.

Class II: Devices with moderate risk whose malfunction have a low risk of causing immediate death or harm to the patient, such as a diagnostic specimen kit.

Class III: Devices associated with a high amount of risk. In some cases, failure with these devices could result in immediate death or harm to the patient, such as a pacemaker. It is important, note, however, that this is mostly risk-based.

FDA medical device regulation requirements increase through the classes, along with testing standards. Most of the Class I medical devices are exempt from Premarket Notification 510(k), whereas most Class II devices are non-exempt.

The Code of Federal Regulations states whether a medical device is required to have a 510(k) or if the device is exempt, so there is no need to guess. Due to the high-risks associated with Class III devices, most require Premarket Approval.

Special controls may be required for Class II medical devices. This could be as simple as special labeling requirements. Be sure to check if your device requires special labeling or other specific controls.

A 510(k) will be required anytime a medical device manufacturer plans to market a device for the first time or has made major adjustments to an existing device. It is important to note, there is a 510(k) device user fee.

Class III medical devices must go through a Pre-Market Approval Program (PMA). This involves completing a thorough application submission for high-risk medical devices.

Again, whether a PMA is required can be identified through the Code of Federal Regulations. The PMA could be required if a medical device is not substantially equivalent to any other device on the market.

According to the FDA, a medical device is considered to have substantial equivalence if it has the same intended use and technological characteristics as the predicate device.

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