Description
For questions regarding this document contact the Office of Radiological Health atRadHealth@fda.hhs.gov.
Scope & Applicability
Product Classes
5Laser emission limits requiring CDRH approval
Broad category including laser products regulated by CDRH.
low solubility, low permeability
Laser risk class defined in 21 CFR 1040.10
The upper accessible emission limit for visible SLA laser products.
Stakeholders
2Entities possessing a variance approval for LLS
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1The date upon which a variance is no longer valid.
Identified Hazards
Hazards
2Basis for CDRH to withdraw a variance
The primary safety concern for laser product variances.
Related CFR Sections (8)
- 21CFR1002.30§ 1002.30 Records to be maintained by manufacturers.
(a) Manufacturers of products listed under table 1 of § 1002.1 shall establish and maintain the following records with respect to such products:Read full regulation →
- 21CFR1002.20§ 1002.20 Reporting of accidental radiation occurrences.
(a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, report to the Director, Center for Devices and Radiological Health, all accidental radiation occurrences reported to or otherwise known to the manufacturer and arising from theRead full regulation →
- 21CFR1002.11§ 1002.11 Supplemental reports.
Prior to the introduction into commerce of a new or modified model within a model or chassis family of a product listed in table 1 of § 1002.1 for which a report under § 1002.10 is required, each manufacturer shall submit a report with respect to such new or modified model describing any changes in Read full regulation →
- 21CFR1002.10§ 1002.10 Product reports.
Every manufacturer of a product or component requiring a product report as set forth in table 1 of § 1002.1 shall submit a product report to the Food and Drug Administration, Center for Devices and Radiological Health, ATTN: Electronic Product Reports, Document Mail Center, 10903 New Hampshire Ave.,Read full regulation →
- 21CFR1010.4§ 1010.4 Variances.
(a) Criteria for variances.Read full regulation →
- 21CFR1002.13§ 1002.13 Annual reports.
(a) Every manufacturer of products requiring an annual report as specified in table 1 of § 1002.1 shall submit an annual report summarizing the contents of the records required to be maintained by § 1002.30(a) and providing the volume of products produced, sold, or installed.Read full regulation →
- 21CFR1040.11§ 1040.11 Specific purpose laser products.
(a) Medical laser products. Each medical laser product shall comply with all of the applicable requirements of § 1040.10 for laser products of its class. In addition, the manufacturer shall: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)
- CPG Sec. 398.375 Obligations of Factory-based Manufacturers and Assemblers of Diagnostic X-ray Equipment Under the Performance Standard for Diagnostic X-ray Equipment (Status: Final)
- Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA Staff (Status: Final)
- Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) (Status: Final)
- Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11 (Status: Final)
- Product Recalls, Including Removals and Corrections: Guidance for Industry (Status: Final)
- CPG Sec. 396.300 Defective Suntanning Booths and Bed (Status: Final)
- Compliance Guide for Laser Products (FDA 86-8260) (Status: Final)
- Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40 (Status: Final)