Description
This guideis intended to help manufacturers of high-intensity mercury vapor discharge lamps to establish adequate quality control and testing programs for compliance with the Federal performance standard for such lamps (21 GR 1040.30). It is intended as guidance and to define good manufacturing. practice in this area. Although, specific sampling plans are included in Section 4, other sampling plans could be used as long as they provide equal protection and assurance of compliance.
Scope & Applicability
Product Classes
8Subject of the performance standard and guidance
High-Intensity Discharge lamps being tested in the chamber
Testing procedures for all HID lamps certified by the manufacturer
Procedures for the measurement of the extinguishing time
Lamps requiring manufacturer certification under the standard
Subject of the performance standard and quality control practices; The primary product subject to the performance standard; Subject of the performance standard and quality control practices.
T Type lamps designed to extinguish if the envelope breaks
R Type lamps requiring specific warning statements
Stakeholders
4Entity responsible for submitting NDINs
determines frequency and acceptance criteria of system suitability evaluations; person who modifies instrument conditions during robustness testing
FDA role responsible for receiving physical samples
outsourced operation provider
Regulatory Context
Attributes
10Performance characteristic required by the standard
Compressed air regulator setting
Required test chamber temperature range
Required label for lamps that do not self-extinguish
Required label for self-extinguishing lamps
Quality index variant used in the continued section of Table XI
Quality index value used as a row identifier in the estimation table
statistically justified calculation required in the plan
Estimating the Lot Percent Defective using statistical tables
Identifier used to determine the number of units to be inspected.
Identified Hazards
Hazards
5Inherent hazard during testing of mercury vapor lamps; Hazard inherent with these tests
Radiation hazard addressed by the UF-3 plastic window
Risk mitigated by special controls
Inherent hazard during laboratory testing
Inherent hazard during testing; Hazard inherent with these tests
Related CFR Sections (5)
- 21CFR1040.30§ 1040.30 High-intensity mercury vapor discharge lamps.
(a) Applicability. The provisions of this section apply to any high-intensity mercury vapor discharge lamp that is designed, intended, or promoted for illumination purposes and is manufactured or assembled after March 7, 1980, except as described in paragraph (d)(1)(ii) of this section.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 →
- 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 →
- 21CFR1010.3§ 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 →
Related Warning Letters (1)
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
See Also (8)
- Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30) (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)
- Manufacture and Certification of Laser Kits (Laser Notice 13) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3) (Status: Final)
- Procedures for Laboratory Testing of Microwave Ovens (Status: Final)
- Quality Control Guide for Sunlamp Products (FDA 88-8234) (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)