The medical device market is highly regulated. As a medical device manufacturer, you will need to comply with regulations to get your products on the USA market. This includes undergoing testing, document review and auditing.
A 510(k) submission is the most common way of getting a medical device on the US market. The US FDA has instituted the third party 510(k) review (3P501k), a program by which designated companies can review certain moderate to low risk products and provide a recommendation to the FDA to allow the 510(k) to be issued. The reason for the program is to speed devices to market by providing a quicker turnaround for 510(k) reviews.
The FDA has also created the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. Under the ASCA Pilot, the FDA grants ASCA Recognition to qualified accreditation bodies to accredit testing laboratories to perform premarket testing for medical device companies. Relying upon international conformity assessment standards and a set of FDA-identified ASCA program specifications, the Pilot is intended to increase consistency and predictability in the FDA's approach to assessing conformance with FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA Pilot in medical device premarket reviews (U.S. Food and Drug Administration, 2021)
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