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

In the US, recall is the standard FDA term, while field safety corrective action (FSCA) is the equivalent international term used in standards like ISO 13485.

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

An 'investigational use only' label indicates the device is in an FDA-regulated clinical trial under an Investigational Device Exemption (IDE) and may only be used per the approved protocol.

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

Under 21 CFR Part 803, user facilities (hospitals) must report device-related deaths to both the FDA and the manufacturer within 10 work days.

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

The GUDID is an FDA-maintained public database where manufacturers submit UDI information, enabling identification of devices during adverse events and recalls.

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 III devices, which are life-sustaining or life-supporting with the highest risk, require the most stringent FDA review: Premarket Approval (PMA).

(BTC) Biomedical Technician Certification Practice Test

(BTC) Biomedical Technician Certification Practice Test

BTC BTC Medical Device Regulations & FDA Compliance 2