CABT Healthcare Technology and Regulations 2 — Questions and Answers
Question 1: Which FDA classification requires the most stringent premarket approval process for medical devices?
- Class I
- Class II
- Class III (Correct answer)
- Class IV
Correct answer: Class III
Class III devices require Premarket Approval (PMA) because they sustain or support life or present a potential unreasonable risk of illness or injury.
Question 2: Under HIPAA, a Business Associate Agreement (BAA) is required when a third-party vendor does which of the following?
- Sells medical equipment to a hospital
- Creates, receives, maintains, or transmits PHI on behalf of a covered entity (Correct answer)
- Provides general IT support with no access to patient data
- Manufactures pharmaceutical supplies
Correct answer: Creates, receives, maintains, or transmits PHI on behalf of a covered entity
A BAA is required whenever a vendor handles Protected Health Information (PHI) on behalf of a HIPAA-covered entity.
Question 3: The primary purpose of the 510(k) premarket notification process is to demonstrate that a new device is:
- Safe and effective through clinical trials
- Substantially equivalent to a legally marketed predicate device (Correct answer)
- Classified as Class I exempt from regulation
- Approved for international distribution
Correct answer: Substantially equivalent to a legally marketed predicate device
The 510(k) pathway requires demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics.
Question 4: Which standard specifically governs electromagnetic compatibility (EMC) requirements for medical electrical equipment in the US?
- IEC 60601-1-2 (Correct answer)
- ANSI/AAMI ES60601-1
- ISO 13485
- UL 2601-1
Correct answer: IEC 60601-1-2
IEC 60601-1-2 is the collateral standard addressing electromagnetic disturbances requirements for medical electrical equipment.
Question 5: A biomedical technician discovers that a ventilator has caused a patient injury. Under FDA MDR regulations, the hospital must report this event within:
- 5 working days for serious injury
- 10 working days for all adverse events
- 30 calendar days, or 5 working days if remedial action was taken (Correct answer)
- 60 calendar days
Correct answer: 30 calendar days, or 5 working days if remedial action was taken
FDA MDR regulations require user facilities to report device-related deaths or serious injuries to FDA within 30 days, or 5 working days if remedial action was taken.
Question 6: Which regulatory body oversees the accreditation of healthcare organizations in the United States and evaluates compliance with safety standards?
- CMS
- The Joint Commission (TJC) (Correct answer)
- OSHA
- FDA
Correct answer: The Joint Commission (TJC)
The Joint Commission accredits and certifies healthcare organizations, evaluating compliance with performance standards to improve patient care quality and safety.
Question 7: An IFU (Instructions for Use) for a medical device must be provided in which language for devices sold in the United States?
- English only (Correct answer)
- English and Spanish
- English and any language spoken by more than 5% of the local population
- English, with translations required if the device is sold in multilingual markets
Correct answer: English only
FDA requires that IFUs for devices marketed in the US be in English, though manufacturers may include additional languages.
CABT Healthcare Technology and Regulations 2
Which FDA classification requires the most stringent premarket approval process for medical devices?