Regulatory Compliance & Standards Flashcards
7 cards from real CPT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Standards flashcards as text
Which federal agency oversees the registration and regulation of prosthetic devices as medical devices in the United States?
Answer: Food and Drug Administration (FDA)
The FDA regulates prosthetic devices as medical devices under the Federal Food, Drug, and Cosmetic Act.
Under OSHA standards, which hazard communication element must be present on all containers of hazardous chemicals used in a prosthetics lab?
Answer: GHS-compliant label with pictograms and signal word
OSHA's Hazard Communication Standard (HazCom 2012) requires GHS-compliant labels including pictograms, signal words, and hazard statements on all hazardous chemical containers.
A prosthetics facility that bills Medicare must enroll in which program to obtain a National Provider Identifier (NPI)?
Answer: PECOS (Provider Enrollment, Chain, and Ownership System)
Medicare requires providers to enroll through PECOS and obtain an NPI before submitting claims for reimbursement.
Which classification does the FDA assign to most custom-fabricated prosthetic limbs?
Answer: Class II (Special Controls)
Most prosthetic limbs are classified as Class II medical devices, subject to special controls and typically requiring 510(k) clearance for new products.
Under HIPAA, which type of information requires the strictest protection in a prosthetics practice?
Answer: Protected Health Information (PHI)
HIPAA's Privacy and Security Rules mandate strict safeguards for Protected Health Information (PHI), which includes any identifiable patient health data.
The ABC Code of Professional Responsibility primarily applies to which individuals in a prosthetics setting?
Answer: Credentialed practitioners and technicians
The ABC Code of Professional Responsibility applies to credentialed practitioners and technicians, outlining ethical and professional conduct standards.
When a prosthetic device causes an unexpected serious injury, the facility is required to report it to the FDA under which program?
Answer: MedWatch / Medical Device Reporting (MDR)
The FDA's Medical Device Reporting (MDR) regulation requires facilities to report device-related serious injuries or deaths through the MedWatch reporting system.