Regulatory Affairs Certification (RAC) Practice Exam

A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA?

1. A Pre-market Approval Application (PMA).

2. An Abbreviated 510(k).

3. A New Drug Application (NDA).

4. A 510(k) submission for a Class II device.

The correct answer is: An Abbreviated 510(k).

The correct answer indicates that the manufacturer is preparing an Abbreviated 510(k) submission. This type of submission is specific to Class II medical devices that are considered to be substantially equivalent to a predicate device already on the market. The Abbreviated 510(k) option allows manufacturers to demonstrate conformity with specific regulatory requirements, including design control requirements. In this context, the Declaration of Conformity is a vital aspect of the submission process, as it verifies that the device meets the necessary specifications and standards, including those outlined in design controls. The Abbreviated 510(k) pathway thus serves to streamline the review process while ensuring that devices maintain compliance with established safety and effectiveness standards. Submitting a Pre-market Approval Application (PMA) is generally required for high-risk Class III devices and does not typically involve an Abbreviated 510(k) or a Declaration of Conformity in the same capacity as Class II submissions. While a 510(k) submission for a Class II device is also a possibility, the qualifier of "Abbreviated" implies that the submission process is being optimized based on the manufacturer’s ability to reference existing guidelines and previous predicates. A New Drug Application (NDA) pertains to pharmaceuticals and does not apply to medical