FDA Exempts Some Devices from Premarket Notification


Posted January 13, 2020

In a final rule titled Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices, the Food and Drug Administration (FDA) identified several Class I and Class II medical devices for which 510(k) premarket notifications are no longer required. The final order, which was published in the Federal Register on Dec. 30, amends the Code of Federal Regulations (CFR) to reflect final determinations for these exemptions.

Numerous Class I and Class II devices appearing in the following parts of 21 CFR were affected by the final rule:

  • 21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and 890
    • Medical devices
  • 21 CFR Part 864
    • Blood
    • Medical devices
    • Packaging and Containers
  • 21 CFR Part 866
    • Biologics
    • Laboratories
    • Medical devices
  • 21 CFR Part 886
    • Medical devices
    • Ophthalmic goods and services
  • 21 CFR Part 892
    • Medical devices
    • Radiation protection
    • X-rays

For example:

  • In 21 CFR Part 864 (“Hematology and Pathology Devices”), paragraph (b) of § 864.5425 (“Multipurpose system for in vitro coagulation studies”) has been revised as follows: “(b) Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.”
  • In 21 CFR Part 866 (“Immunology and Microbiology Devices”), paragraph (b) of § 866.5470 (“Hemoglobin immunological test system”), was revised as follows: “(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.”
  • In 21 CFR Part 868 (“Anesthesiology Devices”), paragraph (b) of § 868.2385 (“Nitrogen dioxide analyzer”) was revised to read as follows: “(b) Classification. Class II (special controls). The device, when it is a standalone nitrogen dioxide analyzer and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's ‘Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.’ See § 868.1(e) for the availability of this guidance document.”

The FDA stated, in a section titled “Limitations on Exemption” in the final rule, that “exemption from the requirement of premarket notification does not mean the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.”

The agency also wrote that exempting certain devices from premarket notification “decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.”

According to FDA, 510(K) premarket notifications are submitted to the agency “to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval.”

·        21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and 890

o   Medical devices

·        21 CFR Part 864

o   Blood

o   Medical devices

o   Packaging and Containers

·        21 CFR Part 866

o   Biologics

o   Laboratories

o   Medical devices

·        21 CFR Part 886

o   Medical devices

o   Ophthalmic goods and services

·        21 CFR Part 892

o   Medical devices

o   Radiation protection

o   X-rays