Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
View Information Collection (IC)
View Information Collection (IC)
IC Title:
Reporting and Recordkeeping for Electronic Products - General Requirements
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 1000.1005.22
21 CFR 1000.1004.2
21 CFR 1000.1005.10
21 CFR 1000.1005.21
21 CFR 1000.1005.25
21 CFR 1000.1010.2
21 CFR 1000.1010.3
21 CFR 1000.1010.4
21 CFR 1000.1010.5
21 CFR 1000.1010.13
21 CFR 1000.1020.20
21 CFR 1000.1020.30
21 CFR 1000.1020.32
21 CFR 1000.1020.33
21 CFR 1000.1020.40
21 CFR 1000.1030.10
21 CFR 1000.1040.10
21 CFR 1000.1040.11
21 CFR 1000.1040.30
21 CFR 1000.1050.10
21 CFR 1000.1002.3
21 CFR 1000.1002.11
21 CFR 1000.1002.10
21 CFR 1000.1002.12
21 CFR 1000.1002.13
21 CFR 1000.1002.20
21 CFR 1000.1002.30
21 CFR 1000.1002.41
21 CFR 1000.1002.31
21 CFR 1000.1002.40
21 CFR 1000.1002.50
21 CFR 1000.1002.51
21 CFR 1000.1003.10
21 CFR 1000.1003.11
21 CFR 1000.1003.20
21 CFR 1000.1003.21
21 CFR 1000.1003.22
21 CFR 1000.1003.30
21 CFR 1000.1003.31
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form and Instruction
2877
Declaration of Imported Electronic Products
07_FDA_Form_2877_Declaration_Imported_Electronic_Products.pdf
Yes
Yes
Fillable Printable
Form and Instruction
2579
Assembler Report
05_FDA_2579_Assembler_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
2767
Notice of Availability-Sample electronic Product
06_FDA_Form_2767_Notice_Availability_Sample_Electronic_Product.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3147
Laser Light Show Variance Application
08_FDA_Form_3147_Laser_Light_Show_Variance_Application.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3649
Accidental Radiation Occurence
09_FDA_Form_3649_Accidental_Radiation_Occurrence.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3626
Diagnostic XRay Major Componets Product
10_FDA_Form_3626_Diagnostic_XRay_Major_Components_Product_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3627
Diagnostic XRay CT Report
11_FDA_Form_3627_Diagnostic_XRay_CT_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3628
General Annual Report
12_FDA_Form_3628_General_Annual_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3629
Abbreviated Report
13_FDA_Form_3629_Abbreviated_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3630
Sunlamp Product Report
14_FDA_Form_3630_Sunlamp_Product_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3631
Sunlamp Annual Report
15_FDA_Form_3631_Sunlamp_Annual_Report_.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3632
Laser Product Report
16_FDA_Form_3632_Laser_Product_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3633
General Variance Request
17_FDA_Form_3633_General_Variance_Request.pdf.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3634
TV Annual Report
18_FDA_Form_3634_TV_Annual_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3635
Laser Light Show Nodification
19_FDA_Form_3635_Laser_Light_Show_Notification.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3636
Laser Light Show Annual Report
20_FDA_Form_3636_Laser_Light_Show_Annual_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3637
Laser Original equipment Manufacturer Report
21_FDA_Form_3637_Laser_Original_Equipment_Manufacturer_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3638
Annual Report XRay Components and Systems
22_FDA_Form_3638_Annual_Report_XRay_Components_and_Systems.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3639
Cabinet XRay System Product Report
23_FDA_Form_3639_Cabinet_XRay_System_Product_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3640
Laser Light Show Product Report
24_FDA_Form_3640_Laser_Light_Show_Product_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3641
Cabinet XRay Annual Report
25_FDA_Form_3641_Cabinet_XRay_Annual_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3642
General Correspondence
26_FDA_Form_3642_General_Correspondence.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3643
Microwave Annual Report
27_FDA_Form_3643_Microwave_Annual_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3644
Ultrasonic Therapy Product Report
28_FDA_Form_3644_Ultrasonic_Therapy_Product_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3645
Ultrasonic Therapy Annual Report
29_FDA_Form_3645_Ultrasonic_Therapy_Annual_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3646
Mercury Vapor Lamp Product Report
30_FDA_Form_3646_Mercury_Vapor_Lamp_Product_Report.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3647
Mercury Vapor Lamp Annual Report
31_FDA_Form_3647_Mercury_Vapor_Lamp_Annual_Report.pdf
Yes
Yes
Fillable Printable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
4,100
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
0 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
47,355
0
0
12
0
47,343
Annual IC Time Burden (Hours)
342,889
0
0
17,932
0
324,957
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.