Medical Devices – U.S. Regulatory Framework
The Food and Drug Administration (FDA) is the authority regulating Medical Devices in the U.S., to ensure their safety and effectiveness. Medical devices are divided into three classes (I, II and III) and this classification defines the regulatory requirements for each device type.
Liliana Teles

Liliana Teles

Regulatory Affairs Manager

MEDICAL DEVICES LEGAL FRAMEWORK IN THE U.S.

All medical devices must comply with the General Controls of the Medical Device Amendments (1976) to the Food, Drug and Cosmetic Act (FD&C Act). General Controls provide the U.S. Food and Drug Administration (FDA) the methods for regulating devices. The FDA’s Center for Devices and Radiological Health (CDRH) is in charge of regulating companies who manufacture, repackage, relabel and/or import medical devices which are sold in the United States (U.S.).

In the General Controls are included provisions concerning: adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification and repair, replacement and refund; records and reports; restricted devices and Good Manufacturing Practices (GMP).

Medical devices are divided in three risk classes (I, II and III). This means that the medical device classification will depend on risk to patient/user, intended use and indications for use. All three classes are subject to the General Controls provisions of the Amendments. Class I medical devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health. These medical devices may not present a potential unreasonable risk of illness or injury. According to the Amendments, Class I medical devices are the ones which pose the lowest risk.  Class III devices are those with the greatest risk and consequently are most regulated, being subjected to premarket approval (PMA).

For Class I and Class II devices, a 510(k) premarket must be submitted. This submission requires demonstration of a substantial equivalence to another legally marketed device in the U.S. A non-equivalent device must have an approved premarket approval (PMA) application or be reclassified into Class I or Class II before being marketed.

Some medical devices considered Class I and II are exempt from 510(k) requirements), but they must still comply with other requirements (regulatory controls) unless the device is explicitly exempt from those requirements as indicated in the regulation for that device type. A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device.

Establishments of medical devices manufacturers (and other specified processors) must be registered with the FDA. A list of all the devices manufactured in such establishments must also be provided. The same applies to importers, repackers and relabelers of medical devices.

The FDA may restrict the sale, distribution or use of a medical device if its safety and effectiveness cannot be assured.

INTRODUCING MEDICAL DEVICES IN THE U.S.

Classification of the medical device is the first step for its placement in the U.S. market. Secondly, the company needs to identify the correct premarket submission, which will depend on the medical device classification. For a Class I or Class II device (not exempt), a premarket submission (510(k)) needs to be submitted to FDA to demonstrate that the device is safe and effective, at least 90 days before introducing the device onto the market. It is not possible to commercially distribute the medical device until a letter of substantial equivalence from FDA authorizes it.

When it comes to Class III medical devices, it is mandatory a premarket approval application (PMA), unless there is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA’s have not been called for. A 510(k) premarket submission would be the way to go in that case. The PMA process is more complex and includes submission of clinical data to support claims made for the device. A fee must be paid both in 510(k) premarket submission and PMA application.

After documents submission and payment of correspondent fees, the FDA will review the submission and decide on the approval of the medical device, within 90-180 days. Class I and Class II device manufacturers are not inspected by the FDA before device registration. Nevertheless, the FDA may conduct random inspections after registration.

Finally, the medical device establishment must be registered in the FDA and the correspondent fees must be paid. The company and device registration status will be listed on the FDA website and the authorization granted will not expire as long as there are no changes made to the medical device (design, intended use, etc.)

References:

U.S. Food and Drug Administration (FDA) – Overview of Device Regulation – https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

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