Question

The regulatory affairs professional should perform all of the following prior to submitting a PMA to FDA EXCEPT:

A. Prepare criteria for the MDR report
B. Prepare a brief statement of reasons for noncompliance with regulation
C. Identify all omissions in PMA content
D. Review, organize and check adequacy of data pertaining to safety and efficacy
evaluation

Answer 1

The regulatory affairs professional should perform all of the following prior to submitting a PMA to FDA EXCEPT: preparing criteria for the MDR report, preparing a brief statement of reasons for noncompliance with regulation, and identifying all omissions in PMA content.

Step-by-step explanation:

The regulatory affairs professional should perform all of the following prior to submitting a PMA to FDA EXCEPT:

1. Prepare criteria for the MDR report
2. Prepare a brief statement of reasons for noncompliance with regulation
3. Identify all omissions in PMA content
4. Review, organize and check adequacy of data pertaining to safety and efficacy evaluation

The correct answer is D. Review, organize and check adequacy of data pertaining to safety and efficacy evaluation.