U.S. Market Access - FDA 510(k)
In order to legally sell or distribute Class II but also some Class I and Class III medical devices in the U.S., manufacturers must first obtain clearance for their device from the U.S. Food and Drug Administration (FDA). In order to obtain clearance, manufacturers are required to submit a 510(k) premarket notification. Manufacturers are also required to file a 510(k) submission in cases where a previously cleared device has been modified in a way that its safety or effectiveness might be affected. Modifications that could trigger a new 510(k) submission include changes to the design, material, chemical composition, energy source, manufacturing process or intended use of the device. In case of a 510(k) submission, the new device is compared with devices already legally marketed in the USA, and its safety and effectiveness are evaluated.
FDA Accredited Persons Program
Under its Accredited Persons Program, the FDA must review and respond to 510(k) submissions from authorised Third Party organisations within 30 days of receipt. The review timeline for direct 510(k) submissions to FDA is 90 days beginning from the date of the initial submission. In the event that FDA requests additional information from the manufacturer and time is needed by the manufacturer to provide this, the review timeline will be extended to a maximum of 180 days. Direct submissions are subject to FDA fees of approximately $10,500 (USD) or small business fees of approximately $2,600 (USD).
After a medical device has received FDA clearance, the manufacturer should prepare for an FDA inspection. This production site inspection verifies that the facility is in compliance with the requirements of a a quality management system, according to 21 CFR Part 820. The quality management system requirements cover areas including production and process controls, corrective and preventative actions, product development and management.
Why choose TÜV SÜD
TÜV SÜD Product Service 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 Product Service 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.
Our services at a glance
- 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.
- Internationally recognised certification - TÜV SÜD is a Nationally Recognised Testing Laboratory (NRTL) and can issue type certification for the US and Canada. Additionally, TÜV SÜD can issue CB Scheme test reports and certificates following a test project. TÜV SÜD CB reports are widely recognised and accepted across the world.
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 Product Service is recognised
- 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 TÜV SÜD 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 worldwide.
- 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.