- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
Numerous questions have arisen regarding the applicability of 21 CFR 1040.lO(i), Modification of a Certified Product, in those situations in which a firm purchases a certified Class I laser product and incorporates it into another product for sale. Examples of this practice include certified Class I optical disc drive units incorporated into computers, compact disc players installed in home entertainment centers, and compact disc players installed in automobiles.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.