Reference no: EM133199264

1. A company that manufactures a combination drug/device product must:

a. Comply with all of the QSRs and the GMPs

b. Maintain two separate quality systems, one for the device constituent and one for the drug constituent

c. Select an option outlined in CFR 4 and comply with that

2. True or False: Unlike drugs, devices can sometimes be released even if they do not conform to all specifications.

3. True or False: 21CFR 820 and ISO 13485 are very different documents because the FDA has not shown any interest in alignment.

4. Why is the FDA not actively regulating LDTs? MORE THAN ONE ANSWER

a. The FDA does not need to regulate LDTs because they are sufficiently regulated by CLIA, which includes a review of the clinical validity of the test itself

b. The FDA was positioned to regulate LDTs in 2017 but largely abandoned the effort because their legal authority was unclear and the newly elected group of lawmakers did not support the effort

c. Despite stating that it would stand down until Congress passed clear legislation granting the FDA authority to regulate LDTs, the FDA was attempting to regulate LDTs on an ad hoc basis until 2020, when the Secretary of HHS ordered them to stop.

d. All of the above are some of the many reasons FDA is not actively regulating LDTs

5. True or False: It would be nice for the FDA to regulate LDTs, but it is not a priority because so far, no one has really been affected by faulty tests.