The U.S. Food and Drug Administration (FDA) has identified an extensive list of Class 1 medical devices that it says will no longer be subject to pre-market notification requirements.
In an agency Notice published in the Federal Register on April 13th, the FDA noted that the exemption of more than 70 different device types was effective immediately, and that the exemptions would “decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.” The FDA said that its decision was based “on the assurances of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.”
Newly exempt Class 1 devices must still meet other regulatory obligations to be legally sold in the U.S., including requirements related to the maintenance of a suitable quality system.
The FDA’s action follows its proposal in March to exempt several hundred Class II medical devices from 510(k) requirements. That proposal would eliminate more than 300 separate product codes from premarket notification requirements, about 12 percent of the approximately 2800 product codes that currently require FDA review.
Both actions by the FDA are part of the agency’s effort to implement the statutory components of the 21st Century Cures Act, passed by the U.S. Congress in late 2016.
