What Medical Devices Aren’t Regulated By The Food & Drug Administration (FDA)?
How does the United States Food & Drug Administration (FDA) define a medical device?
With so many medical devices out on the market, medical device importance for hospitals and our healthcare industry cannot be understated. 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 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 any of its primary intended purposes.”
What medical devices does the FDA regulate?
Technically all medical devices are regulated and classified by the FDA. Indeed, FDA regulates firms that manufacture, import, repackage, or relabel medical devices sold in the United States. The FDA also regulates radiation-emitting electronic products (medical and non-medical). Radiation-emitting products include televisions, lasers, x-ray systems, ultrasound equipment, microwave ovens, amongst other healthcare and household items. However, some Class I and Class II medical devices are exempt from 510(k) premarket notification submissions.
Examples of manufacturers that must list their devices with the FDA include:
- Any manufacturers (including manufacturers of “export only” devices)
- Contract manufacturers
- Specification developers
- Contract sterilizers
- Re-packagers and re-labelers
- Re-processors of single-use devices
- Remanufacturer
- Manufacturers of accessories and components sold directly to the end-user
What is a 510(k) premarket notification?
Medical device development costs are high. A 510(k) premarket notification submission can help you save money on medical device development costs and is a submission made to the FDA before a device is marketed that demonstrates the device is safe and effective, as evidenced by its equivalence to another similar device already legally sold. A medical device that requires a 510 (k) premarket notification cannot be marketed in the U.S. until a letter from the FDA confirming the device’s substantial equivalence is received. This letter of substantial equivalence clears the medical device for commercial distribution.
A medical device is considered substantially equivalent if it meets one of the following conditions:
- The device has the same intended use and technological characteristics as the predicate device.
- The device has the same intended use and different technical characteristics but does not raise questions of safety and effectiveness.
If there are differences in technological characteristics between a medical device and the predicate device, performance data will need to be provided to the FDA for analysis. Examples of performance data are clinical data, engineering performance testing, electromagnetic compatibility, software validation, and biocompatibility evaluations. You may wish to consider a contract testing organization to acquire your FDA performance data.
Which medical devices are exempted from 510(k) submissions?
Class I Devices
The FDA provides 510(k) exemptions for nearly all Class I medical devices. Exceptions to Class I 510(k) exemptions are reserved devices. A list of reserved medical devices can be found HERE. While Class I devices may have a 510(k) exemption, device manufacturers are still required to register their establishment and list the generic category or classification name for the marketed medical device. The same is true for Class II devices.
Class II Devices
Specific Class II devices are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) or the 21st Century Cures Act of 2016 (Cures Act). Table 1 below includes links to Class I and Class II 510 (k) exempt medical devices by device category.
Class I and Class II 510(k) Exempt Medical Devices
PART 610. GENERAL BIOLOGICAL PRODUCTS STANDARDS
PART 660. ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
PART 862. CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
PART 864. HEMATOLOGY AND PATHOLOGY DEVICES
PART 866. IMMUNOLOGY AND MICROBIOLOGY DEVICES
PART 868. ANESTHESIOLOGY DEVICES
PART 870. CARDIOVASCULAR DEVICES
PART 872. DENTAL DEVICES
PART 874. EAR, NOSE, AND THROAT DEVICES
PART 876. GASTROENTEROLOGY-UROLOGY DEVICES
PART 878. GENERAL AND PLASTIC SURGERY DEVICES
PART 880. GENERAL HOSPITAL AND PERSONAL USE DEVICES
PART 882. NEUROLOGICAL DEVICES
PART 884. OBSTETRICAL AND GYNECOLOGICAL DEVICES
PART 886. OPHTHALMIC DEVICES
PART 888. ORTHOPEDIC DEVICES
PART 890. PHYSICAL MEDICINE DEVICES
PART 892. RADIOLOGY DEVICES
Summary
Essentially all medical devices manufactured or marketed in the United States are regulated by the FDA. However, some medical devices are exempt from 510(k) premarket notification submissions. A 510(k) premarket notification submission is made to the FDA before a device is marketed that demonstrates the device is as safe and effective, as evidenced by its equivalence to another similar device already on the market. Most Class I and some Class II medical devices are exempt from 510(k) premarket notification submissions. Links to Class I and Class II 510(k) exempt devices by healthcare category are provided in Table 1 above. Links from Table 1 can also be found in the U.S. Food & Drug Administration article on “Medical Device Exemptions 510(k) and GMP Requirements.” Overall, ensure you choose a contract testing organization that can provide appropriate regulatory testing for your unique medical device or product needs.
Ethide Labs is a contract testing organization specializing in Microbiology Testing. Ethide Labs also offers Bioburden Testing, Bacterial Endotoxin Testing, EO Residual Testing, Sterility Testing, Cytotoxicity Testing, Environmental Monitoring & Package Integrity Testing services for medical device companies and allied industries. Ethide is an ISO 13485 certified facility.
References
U.S. Food & Drug Administration. Medical Device Exemptions 510(k) and GMP Requirements. November 2021.
U.S. Food & Drug Administration. Medical Device Overview. September 2018.
U.S. Food & Drug Administration. Overview of Device Regulation. September 2020.
U.S. Food & Drug Administration. Premarket Notification 510(k). March 2020.
