Description
This guidebriefly summarizes the requirements of the regulations under the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control, that applies to manufacturers of laser products. It explains the performance, labeling, and informational requirements of the standard and the procedures for remedial actions and for variances or exemptions. It does not replace the regulations, however, and if there is any conflict between the guide and the regulations, the regulations must prevail. Throughout this guide, pertinent sections of Title 21, Code of Federal Regulations, Chapter I, Subchapter J, are cited in parentheses. Please consult them before making design or procedural decisions.
Scope & Applicability
Product Classes
10Certified laser products incorporated into other products
Laser products intended for in vivo irradiation
Requires manual reset and specific labeling
Requires remote interlock connector and key control
laser components for sale to manufacturers of laser products
General manual surgical instruments exempt from 510(k)
Visible emission not exceeding Class I for 1000 seconds or less; Laser product classification
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
The upper accessible emission limit for visible SLA laser products.
Laser risk class defined in 21 CFR 1040.10
Stakeholders
3Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Individual responsible for educating employees on hazards
Entity responsible for submitting NDINs
Identified Hazards
Hazards
5possible, suspected, and known exposures
Safety concern addressed in the guidance.; Reportable event involving unintended radiation emission
Hazardous levels of radiation from which the public must be protected
Risk associated with Class II and higher lasers
Optical, electromagnetic, or x radiation from laser operation
Related CFR Sections (11)
- 21CFR1002.1§ 1002.1 Applicability.
The provisions of this part are applicable as follows:Read full regulation →
- 21CFR1002.12§ 1002.12 Abbreviated reports.
Manufacturers of products requiring abbreviated reports as specified in table 1 of § 1002.1 shall submit, prior to the introduction of such product, a report distinctly marked “Radiation Safety Abbreviated Report” which shall include: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 →
- 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 →
- 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 →
- 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 →
- 21CFR1010.4§ 1010.4 Variances.
(a) Criteria for variances.Read full regulation →
- 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 →
- 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 →
- 21CFR1000.3§ 1000.3 Definitions.
As used in this subchapter J:Read full regulation →
- 21CFR1010.20§ 1010.20 Electronic products intended for export.
The performance standards prescribed in this subchapter shall not apply to any electronic product which is intended solely for export if:Read full regulation →
Related Warning Letters (1)
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
See Also (8)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Compliance Policy Guides Index (Status: Final)
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)
- Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (Status: Final)
- Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22) (Status: Final)
- Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51) (Status: Final)