Description
The regulations in 21 CFR 1002 under the **Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C - Electronic Product Radiation Control* require, among other things, that a manufacturer of an electronic product subject to a performance standard maintain purchaser records received from dealers or distributors (21 CFR 1002.30(b)(2)). Furthermore, 21 CFR 1002.40(a) requires that dealers and distributors of products for which the retail price is not less than $50 obtain such information as is necessary to permit tracing of specific products to specific purchasers. The information required to be obtained by dealers and distributors is specified in 21 CFR 1002.40(b) and must be forwarded immediately to the appropriate manufacturer of the electronic product unless the dealer or distributor elects to hold and preserve such information (21 CFR 1002.40(c)).
Scope & Applicability
Product Classes
4Excluded from the exemption
Excluded from the exemption
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
Subject of the recordkeeping exemption
Stakeholders
3Entity responsible for submitting NDINs
Entity holding the lot of product
Entity responsible for submitting NDINs
Related CFR Sections (5)
- 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 →
- 21CFR1002.41§ 1002.41 Disposition of records obtained by dealers and distributors.
(a) Information obtained by dealers and distributors pursuant to § 1002.40 shall immediately be forwarded to the appropriate manufacturer unless:Read full regulation →
- 21CFR1002.40§ 1002.40 Records to be obtained by dealers and distributors.
(a) Dealers and distributors of electronic products for which there are performance standards and for which the retail price is $50 or more shall obtain such information as is necessary to identify and locate first purchasers if the product is subject to this section by virtue of table 1 of § 1002.1Read full regulation →
- 21CFR1002.50§ 1002.50 Special exemptions.
(a) Manufacturers of electronic products may submit to the Director a request, together with accompanying justification, for exemption from any requirements listed in table 1 of § 1002.1 . The request must specify each requirement from which an exemption is requested. In addition to other informatioRead 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 →
See Also (4)
- CPG Sec. 394.100 Retention of Microwave Oven Test Records (Status: Final)
- Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment (Status: Final)