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MEMORANDUM

Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products (Laser Notice 42) December 1989

Final
Issued by:
Guidance Issuing Office
Center 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.


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.