U.S. MARKET ACCESS – 21 CFR 820
All medical device manufacturers supplying medical devices to the U.S. are required to maintain a quality management system in compliance with the Code of Federal Regulations (CFR) Title 21, otherwise known as 21 CFR 820. The quality management system requirements cover a broad range of areas, including production and process controls, corrective and preventive actions, product development and management.
21 CFR 820 REQUIREMENTS
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.
WHY CHOOSE TÜV SÜD MALAYSIA
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.
OUR SERVICES AT A GLANCE
- Authorised “Accredited Person” under the Accredited Persons (AP) program of the US FDA’s Modernisation Act - TÜV SÜD America Inc. is accredited as an "Accredited Person" to conduct inspections of eligible class II and III medical device manufacturers.
- FDA 510(k) third party review service - TÜV SÜD America has participated in the FDA 510(k) third-party review program since its inception in 1996, and offers third-party submission reviews for over 600 devices. TÜV SÜD medical device experts maintain close contact with FDA reviewers to ensure that issues are promptly addressed, resulting in a more efficient review process and timely product clearance.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.
- GLP compliant biocompatibility evaluations - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
- Other testing and certification services - TÜV SÜD Product Service can conduct compliance testing for medical devices in accordance with other relevant regulations and standards, including IEC 60601-1 and electromagnetic compatibility (EMC).