Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers

Scope & Applicability

• 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 →

• 21CFR1040.20§ 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

  (a) Applicability.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 →

• 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 →

• 21CFR1002.12§ 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 →

• 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 →

• CGMP/QSR/Medical Devices/Adulterated

  Sedecal S.A.

  2025-05-27

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