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, additional time on top of 90 days is given. Direct submissions are subject to FDA fees of approximately $5000 (USD) with small business fees being approximately $2500 (USD).
After a medical device has received FDA clearance, the manufacturer is also subject to production site inspection to verify that the facility is in compliance with the FDA requirements for the maintenance of 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.
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.