FDA Medical Devices

The Food and Drug Administration (FDA) is the agency that regulates medical devices, amongst many other things, in the United States.

What is FDA 

The Food and Drug Administration (FDA) in the United States is a federal agency of the Department of Health and Human Services that is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the food supply, cosmetics, and products that emit radiation.

FDA Medical Devices Definition

Section 201(h) of the Food, Drug, and Cosmetic Act 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:

  1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  2. 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
  3. 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 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. The term “device” does not include software functions excluded pursuant to section 520(o).

FDA Medical Devices Regulation

In the United States, the Code of Federal Regulations (CFR) Title 21 regulates food and drugs manufactured or consumed. The regulations relevant to different topics applicable to medical devices are addressed in different parts of CFR 21.

Some examples are:

  • CFR 21 part 800 (General)
  • CFR 21 part 801 (Labeling)
  • CFR 21 part 803 (Medical device reporting)
  • CFR 21 part 806 (Medical devices; reports of corrections and removals)
  • CFR 21 part 807 (Establishment registration and device listing for manufacturers and initial importers of devices)
  • CFR 21 part 808 (Exemptions from federal preexmption of state and local medical device requirements)
  • CFR 21 part 810 (Medical device recall authority)
  • CFR 21 part 812 (Investigational device exemptions)
  • CFR 21 part 814 (Premarket approval of medical devices)
  • CFR 21 part 820 (Quality system regulation)
  • CFR 21 part 821 (Medical device tracking requirements)
  • CFR 21 part 822 (Postmarket surveillance)
  • CFR 21 part 830 (Unique device identification)
  • CFR 21 part 860 (Medical device classification procedures)
  • CFR 21 part 861 (Procedures for performance standards development)

FDA Medical Devices Classification

There are three FDA risk classes for medical devices.

1. FDA Class 1 Medical Device

Class I devices have the lowest risk. Class I devices can be exempt or not.
If your device is classified as Class I and if it is not exempt, a 510k will be required for marketing.

2. FDA Class 2 Medical Device

Class II devices have a moderate risk. Class I devices can be exempt or not.
If your device is classified as Class II, and if it is not exempt, a 510k will be required for marketing.

3. FDA Class 3 Medical Device

Class III devices have the greatest risk.

For Class III devices, a premarket approval application (PMA) is required unless the device was put on the market prior to 1976 (or is substantially equivalent to such a device) and a PMA is not required. In this case, a 510k is the route to market.

4. FDA Medical Devices Exemptions

Certain classes can be exempt from certain regulatory requirements. These exemptions are listed in the classification regulations of 21 CFR. For ease of use, these exemptions have been collected in the Medical Device Exemptions database.

How do you classify a medical device for the FDA?

To classify a medical device, you need to find the exact regulation that determines the classification for your device. You can either search for a part of the device name in the classification database or you can search for the medical speciality in the device panel.

What devices need FDA approval?

All medical devices need to be registered with the FDA, but exactly what is required for the registration depends entirely on how the device is classified. Except for exempt devices, manufacturers must submit a premarket notification (i.e. a 510(k) clearance) for classes I and II, and a premarket approval (PMA) for class III devices.

Premarket notification or a 501(k) clearance is the easier route and applies to products which are similar to devices already on the market. In this case, you have to demonstrate how your device is different from the existing device, that your device maintains the same levels of safety and effectiveness and that is has the same intended use. You will need to show documented laboratory testing, but you typically won’t require clinical trial results. However, you may be required to submit clinical trial results if you’re submitting a 510(k) for a device that has been significantly changed.

Premarket approvals are required for all Class III devices in order to ensure that the device is safe and effective. This applies for completely new devices (i.e. when there is not sufficient existing research to prove the safety and effectiveness of your device) or if the device is determined to be of a high risk. In this case, the FDA requires extensive scientific evidence to determine that the device is ready to be marketed, and generally means that you have to submit results from both laboratory testing and clinical trials.

What is an FDA-approved medical device?

An FDA-approved medical device is any device that has received premarket approval. This means that the FDA has evaluated the device safety and effectiveness and has determined that the benefits of the device significantly outweigh the risks.

FDA Medical Device Database

There are a number of FDA databases that contain different types of information about medical devices. All databases are listed on the FDA’s Medical Device Databases page.

FDA Guidance Documents for Clinical Evaluations

The FDA provides guidance documents on conducting clinical trials and good clinical practice. All documents are accessible from the FDA Clinical Trials Guidance Documents page.

FDA Medical Device Reporting

The FDA has a mechanism for reporting problems experienced with medical devices.

FDA Acronyms and Abbreviations

All acronyms and abbreviations that are relevant to FDA activities are listed in the Acronyms & Abbreviations database.

FDA Risk Management

For risk management, the FDA currently recognizes ISO 14971 (both the 2007 and the 2019 editions) as consensus standards. The 2007 edition of ISO 14971 will continue to be accepted until December 25, 2022. After this transition period, the FDA will only accept the 2019 edition of the standard. This means that if an organization is compliant to ISO 14971, the FDA will accept the Declaration of Conformity. You can search the Recognised Consensus Standards database.

All details on the approval of medical devices by the FDA is available on the FDA website. However, if you would like some expert insight, please contact us at regulations@arrowfast.tech and we can help you to make your FDA approval process smoother.