Description
Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980 must conform to applicable portions of a performance standard (21 CFR 1040.20, amended effective September 8,1986), and their manufacture must be in accord with the medical devices Good Manufacturing Practices (GMP) regulations promulgated under the Food, Drug, and Cosmetic Act (FD&C).This guideis intended to assist manufacturers of these products in satisfying both the GMP requirements and in developing and implementing quality assurance (QA) programs. This guide provides the criteria and the underlying philosophy used by FDA to evaluate manufacturers' QA programs.
Scope & Applicability
Product Classes
4intended for use in sunlamp products
subject to requirements of 1040.20 including specific danger warnings
Warning label requirements; Products subject to performance standards and warning labels.
Lamps manufactured on or after the effective date must conform to the standard.; Specific component or product type requiring compliance certification.; Lamps intended to be used in sunlamp products
Stakeholders
3Entity responsible for submitting NDINs
Must comply with registration if meeting facility/responsible person definitions
outsourced operation provider
Regulatory Context
Attributes
7A measured property of protective eyewear.; Must not exceed 0.001 over 200-320nm for protective eyewear
Weighting factor or relative effectiveness value for specific wavelengths
Light generation parameter for device description.; Technical parameter in nanometers
sunlamp product manufacturers must develop an exposure schedule
The ten (10) minute maximum timer interval requirement was removed
Specified distance from the detector aperture for sunlamp testing
A quantitative parameter with a required error limit of +/- 10 percent.; The timer must have an accuracy of ±10 percent of the maximum timer interval
Identified Hazards
Hazards
6Potentially hazardous radiation that the Center seeks to control exposure to.
the exposure schedule and maximum recommended exposure time should be constrained by the potential for erythema
The lamp is producing UV and the housing is hot
Inherent hazard during laboratory testing
Inherent hazard during laboratory testing
can cause eye and skin injury, premature aging, and skin cancer
Related CFR Sections (5)
- 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 →
- 21CFR1040.20§ 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a) Applicability.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 →
- 21CFR1002.31§ 1002.31 Preservation and inspection of records.
(a) Every manufacturer required to maintain records pursuant to this part, including records received pursuant to § 1002.41 , shall preserve such records for a period of 5 years from the date of the record.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 →
Related Warning Letters (10)
- 2025-06-03
CGMP/QSR/Medical Devices/Adulterated
DFI Co., Ltd.
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
- 2025-04-08
CGMP/QSR/Medical Devices/Adulterated
EpiCare Acquisitions, LLC
- 2024-11-08
CGMP/QSR/Medical Devices/Adulterated
Rolence Ent. Inc.
- 2024-09-03
CGMP/QSR/Medical Devices/Adulterated
Wissner-Bosserhoff GmbH
- 2024-07-18
CGMP/QSR/Medical Devices/Adulterated
Jiangsu Shenli Medical Production Co., Ltd.
- 2024-06-04
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Techlem Medical Corporation
- 2024-05-07
CGMP/QSR/Medical Devices/Adulterated
Bioptimal International
- 2024-04-30
CGMP/QSR/Medical Devices/Adulterated
P.T. Sankei Medical Industries
- 2024-01-09
CGMP/QSR/Medical Devices/Adulterated
Deymed Diagnostic s.r.o.
See Also (8)
- Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (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)
- Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products (Laser Notice 42) (Status: Final)
- Procedures for Laboratory Testing of Microwave Ovens (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)
- CPG Sec. 398.600 Certification and Identification of X-ray Components - Sections 1010.2 and 1020.30(e) (Status: Final)