RAC devices practice exam questions and verified answers| latest version| grade a+ 2026.

RAC devices practice exam questions and verified answers|
latest version| grade a+ 2026.


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?
A. A PMA
B. A Special 510(k),
C. An Individual Device Exemption (IDE),
D. An Annual Report for a PMA
B. A Special 510(k)




A company wishes to expand existing labeling for a medical device to include a new
indication for use. What action should the regulatory professional take FIRST?
Contact the review division to determine whether a 510(k) or PMA should be
prepared.




A company is submitting a PMA for a permanent implant. The company has
performed biocompatibility testing based on ISO requirements and believes the
package is complete. Which of the following testing does the company absolutely
need to demonstrate long-term safety of its device:
A. Intracutaneous irritation,
B. Genotoxicity,
C. Acute toxicity,
D. Carcinogenicity
D. Carcinogenicity




If a device fails to comply with any paragraph of the QSR is it adulterated?
Yes