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

Issue Date: December 18, 1989
Issued by: Center for Devices and Radiological Health
Topic(s): Radiological Health
Status: Final

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

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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