Laws, Regulations, and Standards Flashcards
7 cards from real NOCE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Laws, Regulations, and Standards flashcards as text
The FDA classifies prescription spectacle lenses as which type of medical device?
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.
Which federal law mandates that ophthalmic lenses dispensed in the US must be impact-resistant unless specifically exempted in writing by the prescriber?
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.
A prescriber exempts a patient from the impact-resistant lens requirement. What must the optician do to comply with 21 CFR 801.410?
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.
OSHA standard 29 CFR 1910.133 requires employers to provide which type of eyewear to employees?
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.
Which standard governs the occupational and educational personal eye protection requirements for safety eyewear?
Answer: ANSI Z87.1
ANSI Z87.1 sets the requirements for occupational and educational eye and face protection devices, including safety glasses and goggles.
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:
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.
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?
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.