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
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).
Your benefits at a glance
- Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
- Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
- Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
- Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.
- Regional and local proficiency - Our regional medical health experts speak your local language and understand regional and local regulations and knowledge needs.