Scope & Applicability
Product Classes
1Laser products sold in kit form for assembly
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Specific topic of importance for diagnostic x-ray equipment.; Required on identification labels in Month and Year format.; Determines which performance standards are applicable; required on identification labels
Identified Hazards
Hazards
1exposure risks requiring warnings and protective housing
Related CFR Sections (3)
- 21CFR1010.3§ 1010.3 Identification.
(a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such prRead full regulation →
- 21CFR1010.2§ 1010.2 Certification.
(a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.Read full regulation →
- 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)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Procedures for Field Testing Microwave Ovens (Status: Final)
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 398.600 Certification and Identification of X-ray Components - Sections 1010.2 and 1020.30(e) (Status: Final)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)
- Identification Labels for Certain Class I Laser Products (Laser Notice 48) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3) (Status: Final)