NOCE Laws, Regulations, and Standards 3

Question 1

The FDA classifies prescription spectacle lenses as which type of medical device?

Accepted Answer

Class II (special controls)

Answer

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?

Accepted Answer

FDA Impact-Resistant Lens Regulation (21 CFR 801.410)

Answer

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?

Accepted Answer

Obtain written exemption from the prescriber and retain it on file

Answer

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?

Accepted Answer

Appropriate eye and face protection for occupational hazards

Answer

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?

Accepted Answer

ANSI Z87.1

Answer

ANSI Z87.1 sets the requirements for occupational and educational eye and face protection devices, including safety glasses and goggles.

NOCE - National Opticianry Competency Examination Practice Test

NOCE - National Opticianry Competency Examination Practice Test

NOCE Laws, Regulations, and Standards 3