Description
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.
Scope & Applicability
Product Classes
1Certified laser products incorporated into other products
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Significant changes to intended use are likely remanufacturing.; The purpose for which the device is used, which must not change.
Related CFR Sections (1)
- 21CFR1040.10§ 1040.10 Laser products.
(a) Applicability. The provisions of this section and § 1040.11 , as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when:Read full regulation →
See Also (8)
- Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40 (Status: Final)
- Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (Status: Final)
- Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) : (Status: Final)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products: Guidance for Industry and Food and Drug Administration Staff (Status: Final)