BTC BTC Medical Device Regulations & FDA Compliance 2

Question 1

What is the difference between a device 'recall' and a 'field safety corrective action'?

Accepted Answer

A recall is an FDA-initiated or voluntary action to remove or correct a device; a field safety corrective action is the broader international term for the same concept

Answer

They are identical terms

Answer

A recall only applies to food products

Answer

A field safety corrective action only applies to software

Question 2

A device is labeled 'for investigational use only.' What does this mean for a biomedical technician?

Accepted Answer

The device is under clinical study and not yet approved; use is restricted to the approved study protocol

Answer

The device is fully FDA-approved for all clinical uses

Answer

The device cannot be repaired

Answer

The device is intended for veterinary use

Question 3

Under FDA regulations, who is responsible for reporting a device-related death from a hospital?

Accepted Answer

The hospital (user facility) is required to report to both the FDA and the manufacturer within 10 work days

Answer

The treating physician only

Answer

The manufacturer alone

Answer

The state health department only

Question 4

What is the purpose of the FDA's GUDID (Global Unique Device Identification Database)?

Accepted Answer

To provide a publicly accessible database of device UDI information for identification and safety tracking

Answer

To store patient medical records

Answer

To manage hospital billing records

Answer

To track physician licensing

Question 5

Which class of medical device requires Premarket Approval (PMA) before it can be marketed in the US?

Accepted Answer

Class III

Answer

Class I

Answer

Class II

Answer

All classes require PMA

Question 6

What does 'off-label use' of a medical device mean?

Accepted Answer

Using an FDA-cleared device for a purpose not included in its cleared indications

Answer

Using a device without reading the manual

Answer

Using a counterfeit device

Answer

Using a device past its expiration date