Manufacturers of medical device supplying to the U.S. are subject to inspection of their quality management systems for compliance with the requirements of 21 CFR 820. As a rule, this takes four working days and encompasses management, development, corrective and preventive action, as well as production and process control.
Manufacturers have the option to apply for participation in the Food and Drug Administration’s (FDA) Accredited Persons (AP) program. After notification from FDA about an inspection of their facility’s quality management system, the manufacturer has to apply with FDA. If FDA agrees to have the inspection done by an Accredited Persons, then the last acceptable date of inspection must be agreed with FDA.
Manufacturers can also initiate an AP inspection with the US FDA at any time.
Under the Accredited Persons program, TÜV SÜD America Inc. is accredited as an "Accredited Person" to conduct inspections of eligible class II and III medical device manufacturers. We also offer pre-inspections (i.e. mock inspections) based on US FDA regulations. Routine inspections according to 21CFR 820 by TÜV SÜD can also be combined with an audit under EU regulations or CMDCAS.
- Click here to find out how to transfer to TÜV SÜD, the Notified Body of choice