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. A 510(k) submission is based on comparison of the new device with devices already legally marketed in the USA, which allows the US Food and Drug Administration (FDA) to determine whether a device is safe and effective.
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 . 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.
How to ensure a smooth transition to MDR certification.
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