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?

  1. The Occupational Safety and Health Administration (OSHA)
  2. The Food and Drug Administration (FDA)
  3. The Centers for Disease Control and Prevention (CDC)
  4. The Environmental Protection Agency (EPA)
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.

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