CFR section
21 CFR 1040.10(i): Laser products
PART 1040-PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
Key facts
| Citation | 21 CFR 1040.10(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) Modification of a certified product. The modification of a laser product, previously certified under § 1010.2, by any person engaged in the business of manufacturing, assembling, or modifying laser products shall be construed as manufacturing under the act if the modification affects any aspect of the product's performance or intended function(s) for which this section and § 1040.11 have an applicable requirement. The manufacturer who performs such modification shall recertify and reidentify… |
At a glance
- 1–9 Inspections citing this section
- None Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About CFR sections cited by the FDA
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.