NOCE Laws, Regulations, and Standards 3 — Questions and Answers
Question 1: The FDA classifies prescription spectacle lenses as which type of medical device?
- Class I (general controls)
- Class II (special controls) (Correct answer)
- Class III (premarket approval)
- Not classified as a medical device
Correct answer: Class II (special controls)
Prescription spectacle lenses are classified by the FDA as Class II medical devices, subject to special controls and 510(k) requirements.
Question 2: Which federal law mandates that ophthalmic lenses dispensed in the US must be impact-resistant unless specifically exempted in writing by the prescriber?
- Americans with Disabilities Act
- FDA Impact-Resistant Lens Regulation (21 CFR 801.410) (Correct answer)
- OSHA 29 CFR 1910.133
- FTC Eyeglass Rule
Correct answer: FDA Impact-Resistant Lens Regulation (21 CFR 801.410)
21 CFR 801.410 requires that all prescription ophthalmic lenses be impact-resistant, with limited medical exceptions documented by the prescriber.
Question 3: A prescriber exempts a patient from the impact-resistant lens requirement. What must the optician do to comply with 21 CFR 801.410?
- Refuse to dispense the lenses
- Obtain written exemption from the prescriber and retain it on file (Correct answer)
- Submit the exemption to the FDA for approval
- Have the patient sign a general liability waiver only
Correct answer: Obtain written exemption from the prescriber and retain it on file
The optician must obtain a written, signed statement of exemption from the prescriber and keep it on file as required by 21 CFR 801.410.
Question 4: OSHA standard 29 CFR 1910.133 requires employers to provide which type of eyewear to employees?
- Prescription sunglasses
- Appropriate eye and face protection for occupational hazards (Correct answer)
- Fashion frames with UV coating
- Non-prescription readers
Correct answer: Appropriate eye and face protection for occupational hazards
OSHA 29 CFR 1910.133 mandates that employers ensure employees wear appropriate eye and face protection wherever there is a risk of eye injury from hazards.
Question 5: Which standard governs the occupational and educational personal eye protection requirements for safety eyewear?
- ANSI Z80.1
- ANSI Z80.3
- ANSI Z87.1 (Correct answer)
- ANSI Z80.5
Correct answer: ANSI Z87.1
ANSI Z87.1 sets the requirements for occupational and educational eye and face protection devices, including safety glasses and goggles.
Question 6: An optician in a licensed state dispenses eyeglasses using a prescription that expired 2 years ago without the patient's knowledge. This action primarily violates:
- ANSI Z80.1 power tolerances
- State opticianry licensure law and the FTC Eyeglass Rule (Correct answer)
- OSHA 29 CFR 1910.133
- HIPAA privacy rules
Correct answer: State opticianry licensure law and the FTC Eyeglass Rule
Using an expired prescription without the patient's awareness violates both state licensure laws governing scope of practice and the FTC Eyeglass Rule's requirements for valid prescriptions.
Question 7: According to the FTC Eyeglass Rule, what is the maximum period an ophthalmic prescription can be considered valid if no expiration date is specified by the prescriber?
- 6 months
- 1 year
- 2 years
- The FTC does not set a default; state law governs (Correct answer)
Correct answer: The FTC does not set a default; state law governs
The FTC Eyeglass Rule does not establish a default prescription expiration; expiration periods are governed by individual state laws.
NOCE Laws, Regulations, and Standards 3
The FDA classifies prescription spectacle lenses as which type of medical device?