Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff

Description

FDA is issuing this guidance to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. This is done to recognize that electronic media are now being widely used to provide instruction, while at the same time reducing paper consumption, increasing accessibility and providing rapid means for editing and updating content.

Scope & Applicability

Regulatory Context

• 21CFR1002.13§ 1002.13 Annual reports.

  (a) Every manufacturer of products requiring an annual report as specified in table 1 of § 1002.1 shall submit an annual report summarizing the contents of the records required to be maintained by § 1002.30(a) and providing the volume of products produced, sold, or installed.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 →

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

  (a) Applicability.Read 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 →

• 21CFR1030.10§ 1030.10 Microwave ovens.

  (a) Applicability. The provisions of this standard are applicable to microwave ovens manufactured after October 6, 1971.Read full regulation →

• 21CFR1020.40§ 1020.40 Cabinet x-ray systems.

  (a) Applicability. The provisions of this section are applicable to cabinet x-ray systems manufactured or assembled on or after April 10, 1975, except that the provisions as applied to x-ray systems designed primarily for the inspection of carry-on baggage are applicable to such systems manufacturedRead full regulation →

• 21CFR1020.30§ 1020.30 Diagnostic x-ray systems and their major components.

  (a) Applicability.Read full regulation →

• 21CFR1020.20§ 1020.20 Cold-cathode gas discharge tubes.

  (a) Applicability. The provisions of this section are applicable to cold-cathode gas discharge tubes designed to demonstrate the effects of a flow of electrons or the production of x-radiation as specified herein.Read full regulation →

• 21CFR1002.3§ 1002.3 Notification to user of performance and technical data.

  The Director and Deputy Director of the Center for Devices and Radiological Health, as authorized under delegated authority, may require a manufacturer of a radiation emitting electronic product to provide to the ultimate purchaser, at the time of original purchase, such performance data and other tRead full regulation →

• Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA Staff (Status: Final)
• Compliance Guide for Cabinet X-Ray Systems (Status: Final)
• Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) (Status: Final)
• Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)
• Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
• Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (Status: Final)
• Compliance Guide for Laser Products (FDA 86-8260) (Status: Final)
• Procedures for Laboratory Testing of Microwave Ovens (Status: Final)