Ethics & Law · single question
A dentist is uncertain about the safety and approved use of a newly marketed dental laser. Which agency regulates this device?
Show answer and explanation
Correct answer: B. The Food and Drug Administration (FDA)
- A. OSHA regulates WORKER safety in the workplace — it governs how staff must be protected from the laser (eyewear, plume evacuation, training), not whether the device itself is approved.
- B. CORRECT. The FDA — specifically the Center for Devices and Radiological Health (CDRH) — regulates medical and dental DEVICES, including lasers, and is responsible for their premarket clearance, labeling, and radiation-emitting product performance standards. Questions about whether a laser is cleared for a given indication go to the FDA.
- C. The CDC issues infection-control guidance and recommendations, but it is not a regulatory agency and does not clear devices.
- D. The EPA regulates environmental discharges, chemical disinfectants (surface disinfectant registration), and waste — including amalgam separators.
Note: Quick map: FDA = devices and drugs. OSHA = worker safety (enforceable). EPA = environment and surface disinfectants. CDC = recommendations, not law.