Reporting and Recordkeeping for Electronic Products - General Requirements

OMB 0910-0025

OMB 0910-0025

To protect the public from unnecessary exposure to radiation from electronic products, FDA must collect certain information from manufacturers and dealers/distributors about electronic products they sell or install. This ICR collects information from electronic product and x-ray manufacturers, importers, and assemblers. These respondents report and maintain information related to the identification of, location of, operational characteristics of, quality assurance programs for, and problem identification and correction of electronic products. The data reported to the Food and Drug Administration (FDA) and the records maintained are used by FDA and industry to make decisions and take actions that protect the public from radiation hazards presented by electronic products. The information collections are either specifically called for in legislation or were developed to aid FDA in performing its obligations under legislation.

The latest form for Reporting and Recordkeeping for Electronic Products - General Requirements expires 2023-08-31 and can be found here.

All Historical Document Collections
Approved without change
Extension without change of a currently approved collection 2020-07-07
Improperly submitted and continue
Revision of a currently approved collection 2020-07-06
Comment filed on proposed rule and continue
Revision of a currently approved collection 2019-04-03
Approved without change
No material or nonsubstantive change to a currently approved collection 2018-10-30
Approved without change
Reinstatement without change of a previously approved collection 2017-06-15
Approved without change
Extension without change of a currently approved collection 2013-11-20
Approved without change
Extension without change of a currently approved collection 2010-05-24
Approved without change
Extension without change of a currently approved collection 2007-03-14
Approved without change
Extension without change of a currently approved collection 2003-10-24
Approved without change
Extension without change of a currently approved collection 2000-09-11
Approved without change
No material or nonsubstantive change to a currently approved collection 2000-08-31
Approved without change
No material or nonsubstantive change to a currently approved collection 1999-03-15
Approved without change
No material or nonsubstantive change to a currently approved collection 1999-02-22
Approved without change
No material or nonsubstantive change to a currently approved collection 1998-09-13
Approved without change
No material or nonsubstantive change to a currently approved collection 1998-01-05
Approved without change
Reinstatement with change of a previously approved collection 1997-08-27
Approved without change
Reinstatement with change of a previously approved collection 1993-04-27
Approved without change
Reinstatement with change of a previously approved collection 1989-08-03
Approved without change
Revision of a currently approved collection 1988-07-27
Approved without change
Reinstatement with change of a previously approved collection 1985-06-04
Approved without change
Revision of a currently approved collection 1984-08-30
Approved with change
No material or nonsubstantive change to a currently approved collection 1982-03-30
Approved without change
Revision of a currently approved collection 1981-11-20
Approved without change
Revision of a currently approved collection 1979-11-07
Approved without change
Revision of a currently approved collection 1979-06-18
Approved with change
No material or nonsubstantive change to a currently approved collection 1977-11-01
OMB Details

Reporting for Electronic Products

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 3659TV Product ReportFillable FileableForm and instruction
Form FDA 2579Report of Assembly of a Diagnostic X-Ray SystemFillable FileableForm and instruction
Form FDA 3642General CorrespondenceFillable FileableForm and instruction
Form FDA 3637Laser OEM Component ReportFillable FileableForm and instruction
Form FDA 3635LLS NotificationFillable FileableForm and instruction
Form FDA 3633General Variance ApplicationFillable FileableForm and instruction
Form FDA 2877Declaration for Imported Electronic Products Subject to Radiation Control StandardsFillable FileableForm and instruction
Form FDA 2767Notice of Availability of Sample Electronic ProductFillable FileableForm and instruction
Form FDA 3649Accidental Radiation Occurrence ReportFillable FileableForm and instruction
Form FDA 3647Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor LampsFillable FileableForm and instruction
Form FDA 3631Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamp ProductsFillable FileableForm and instruction
Form FDA 3636Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show ProductsFillable FileableForm and instruction
Form FDA 3643Microwave Oven Products Annual ReportFillable FileableForm and instruction
Form FDA 3641Guide for Filing Annual Reports for X-Ray Components and SystemsFillable FileableForm and instruction
Form FDA 3638Guide for Filing Annual Reports for X-Ray Components and SystemsFillable FileableForm and instruction
Form FDA 3634TV Annual ReportFillable FileableForm and instruction
Form FDA 3628Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)Fillable FileableForm and instruction
Form FDA 3663Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens)Fillable FileableForm and instruction
Form FDA 3662A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic UseFillable FileableForm and instruction
Form FDA 3801Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such LampsFillable FileableForm and instruction
Form FDA 3661A Guide for the Submission of an Abbreviated Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic UseFillable FileableForm and instruction
Form FDA 3629General Abbreviated ReportFillable FileableForm and instruction
Form FDA 3660Guidance for Preparing Reports on Radiation Safety of Microwave OvensFillable FileableForm and instruction
Form FDA 3632Guide for Preparing Product Reports for Lasers and Products Containing LasersFillable FileableForm and instruction
Form FDA 3639Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40Fillable FileableForm and instruction
Form FDA 3627A Guide for the Submission of Initial Reports on Computed Tomography X-Ray SystemsFillable FileableForm and instruction
Form FDA 3626A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major ComponentsFillable FileableForm and instruction
Form FDA 3630Guide for Preparing Product Reports on Sunlamps and Sunlamp ProductsFillable FileableForm and instruction
Form FDA 3640Reporting Guide for Laser Light Shows and DisplaysFillable FileableForm and instruction
Form FDA 3644Guide for Preparing Product Reports for Ultrasonic Therapy ProductsFillable FileableForm and instruction
Form FDA 3646Mercury Vapor Lamp Products Radiation Safety ReportFillable FileableForm and instruction
Form FDA 3645Guide for Preparing Annual Reports for Ultrasonic Therapy ProductsFillable FileableForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.


© 2021 OMB.report | Privacy Policy