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Question 1 of 5
1. Question
1 points
A medical device may be deemed “adulterated” for the following reasons (check all that apply):
Correct
Incorrect
Question 2 of 5
2. Question
1 points
Manufacturers must report to the FDA within 30-days when you become aware of information that reasonably suggests that the device you are actively marketing:
Correct
21 CFR 803.50 (a)(1) may have caused or contributed …
Not b. 21 CFR 80.50 (a)(2) HAS malfunctioned, not might but hasn’t yet
Not c. Has malfunctioned, however, a slight shock from a 9-volt battery will never result in death of serious injury
Not d. Reportable events have nothing to do with improving market position. Unsubstantiated claims follows the adulteration rules in 21 USC para 351 (e) not in conformity with performance standards (device registration), and/or (f) class III devices
Incorrect
Question 3 of 5
3. Question
1 points
When is information regarding a MDR (medical device reporting) “reasonably known” to the device manufacturer (check all that apply)?
Correct
All of the above 21 CFR 803.50 (b)(1)(i-iii) i. Any information you can obtain by contacting a user facility ii. Any information in your possession; iii. Information you can obtain by analysis, testing …
Incorrect
Question 4 of 5
4. Question
1 points
The top FDA Inspection Observations are cited against CFR 820.100 (a) and (b). Some common problems with Corrective Actions are (check all that apply):
Correct
a. 820.100 (a)(1) Analysis of: processes …. concessions …. complaints … returned product and other sources to identify … quality problems
820.100 (b) All activities reuired .. and their results, shall be documented
Not b: training programs is not a requirement under 820.100
Not d: since b is incorrect the answer is not “all of the above”
Incorrect
Question 5 of 5
5. Question
1 points
A frequent FDA Inspection Observation is cited against CFR 820.198 compliant files. Some common problems with complaint processes include (check all that apply)?
Correct
820.100 (a)(1) Analysis of: processes …. concessions …. complaints … returned product and other sources to identify … quality problems
820.100 (b) All activities reuired .. and their results, shall be documented
Not b: training programs is not a requirement under 820.100
Not d: since b is incorrect the answer is not “all of the above”