Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff
Guidance for industry
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017