CFR section
21 CFR 1040.10(a)(3)(i): Laser products
PART 1040-PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
Key facts
| Citation | 21 CFR 1040.10(a)(3)(i) |
|---|---|
| Section | Laser products |
| Part | PART 1040-PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS |
| Subchapter | 21 CFR J Radiological |
| Product types cited | Devices |
| Regulation text (excerpt) | (i) Registers, and provides a listing by type of such laser products manufactured that includes the product name, model number, and laser medium or emitted wavelength(s), and the name and address of the manufacturer. The manufacturer must submit the registration and listing to the Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002. |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.