The increasing demand for medical devices has presented excellent opportunities for medical device manufacturers. However, compliance with regulations are rigorous and mandatory for market entry. For the US medical device market, section 510(k) of the Food, Drug and Cosmetic Act stipulates that device manufacturers have to register and notify FDA of their intent to market a medical device at least 90 days in advance.
This is known as Premarket Notification – also called PMN or 510(k).A 510(k) review is thus a premarketing submission to highlight safety and effectiveness of a medical device, unless it is exempted from 510(k) requirements. This allows FDA to determine whether the device has an existing equivalent in the market, or that it can be assigned to one of the three classification categories.
TÜV SÜD is qualified to
- conduct 510(k) review of Class I and Class II medical devices destined for the USA market.
- provide training on FDA 510(k) regulations and processes as well as conduct factory inspection
- evaluate all necessary documentation to identify compliance gaps for our customers so as to obtain a successful 510(k) submission.
- offer a recommendation letter to the FDA on whether the device is substantially equivalent to other legally
marketed devices (predicate devices) in the USA market.