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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

Download the Final Memorandum
Final
Docket Number:
FDA-2020-D-0957
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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All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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