BTC BTC Medical Device Regulations & FDA Compliance 3

Question 1

What is an FDA 'Warning Letter' and what does it mean for a medical device facility?

Accepted Answer

An official FDA communication that a facility has significant violations and must take corrective action to avoid enforcement

Answer

A routine annual compliance notice

Answer

A billing dispute notice

Answer

An invitation to participate in a clinical trial

Question 2

What is the role of a 'Designated Representative' or 'US Agent' for a foreign medical device manufacturer selling in the US?

Accepted Answer

To serve as the FDA's point of contact for the foreign manufacturer's regulatory communications

Answer

To handle device repairs only

Answer

To manage US sales only

Answer

To perform calibrations

Question 3

Under the Safe Medical Devices Act, which type of facility must track certain high-risk devices from distribution to patient?

Accepted Answer

Distributors and device user facilities that implant or use tracked devices

Answer

Outpatient clinics only

Answer

Manufacturers only

Answer

Insurance companies

Question 4

A biomedical technician performs an unauthorized modification to an FDA-cleared device. What is the primary regulatory concern?

Accepted Answer

The modification may change the device's safety/effectiveness profile, potentially making it an adulterated or misbranded device under FDA law

Answer

The device warranty is voided only

Answer

There is no regulatory concern if the modification improves performance

Answer

Only the manufacturer bears responsibility

Question 5

What is 'substantial equivalence' as used in the FDA 510(k) process?

Accepted Answer

The new device has the same intended use and similar technological characteristics (or different characteristics that don't raise new safety concerns) as the predicate

Answer

The new device costs about the same as the predicate

Answer

The new device is manufactured in the same country as the predicate

Answer

The new device has the same color and size as the predicate

Question 6

Which FDA regulation specifically requires medical device manufacturers to establish and follow procedures for complaint handling?

Accepted Answer

21 CFR Part 820.198

Answer

21 CFR Part 50

Answer

21 CFR Part 803

Answer

21 CFR Part 11