BTC BTC Medical Device Regulations & FDA Compliance 2 — Questions and Answers
Question 1: What is the difference between a device 'recall' and a 'field safety corrective action'?
- They are identical terms
- 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 (Correct answer)
- A recall only applies to food products
- A field safety corrective action only applies to software
Correct 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
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?
- The device is fully FDA-approved for all clinical uses
- The device is under clinical study and not yet approved; use is restricted to the approved study protocol (Correct answer)
- The device cannot be repaired
- The device is intended for veterinary use
Correct answer: The device is under clinical study and not yet approved; use is restricted to the approved study protocol
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?
- The treating physician only
- The hospital (user facility) is required to report to both the FDA and the manufacturer within 10 work days (Correct answer)
- The manufacturer alone
- The state health department only
Correct answer: The hospital (user facility) is required to report to both the FDA and the manufacturer within 10 work days
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)?
- To store patient medical records
- To provide a publicly accessible database of device UDI information for identification and safety tracking (Correct answer)
- To manage hospital billing records
- To track physician licensing
Correct answer: To provide a publicly accessible database of device UDI information for identification and safety tracking
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?
- Class I
- Class II
- Class III (Correct answer)
- All classes require PMA
Correct answer: Class III
Class III devices, which are life-sustaining or life-supporting with the highest risk, require the most stringent FDA review: Premarket Approval (PMA).
Question 6: What does 'off-label use' of a medical device mean?
- Using a device without reading the manual
- Using an FDA-cleared device for a purpose not included in its cleared indications (Correct answer)
- Using a counterfeit device
- Using a device past its expiration date
Correct answer: Using an FDA-cleared device for a purpose not included in its cleared indications
Off-label use means employing an FDA-cleared or approved device for an indication, patient population, or method not specified in its cleared labeling.
BTC BTC Medical Device Regulations & FDA Compliance 2
What is the difference between a device 'recall' and a 'field safety corrective action'?