BUMEDINST 6710.63C

Question 1

BUMEDINST 6710.63C

Reporting of defective, unsafe, or unsatisfactory medical and dental materiel

Answer 1

FDA is the federal legislation has increased the authority to whom in monitoring medical safety, while assuring an effective recall program.

Question 2

Defense logistic Agency is who responsible agency to handle reporting of unsafe and defective medical equipment to FDA for the DOD

Answer 2

what form use to initiate all voluntary, mandatory, and vaccine adverse event report to the FDA…SF 368, Product Quality Deficiency Report

Question 3

What category can only be submitted with approval of authorizing medical or dental officer and most serious cause serious injury, illness or loss of life; failure, malfunction, improper, manufacture, labeling, user error ……Category I

Answer 3

complaint do not meet severity level ; systemic equipment failure, defective devices, incorrect or deficient labeling, foreign or particulate matter in liquid or solid, imperfectly manufacture item, suspected sub-potency drug and biologic, pinholes in tubing, faulty calibration and poor quality products……CAT II