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Agenda
Reg Review
ICR
View Information Collection (IC)
View Information Collection (IC)
IC Title:
Recordkeeping for Electronic Products - General Requirements
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
New
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 1000.1002.40
21 CFR 1000.1002.30
21 CFR 1000.1002.41
21 CFR 1000.1002.31(a)
21 CFR 1000.1020.30(g)
21 CFR 1000.1040.10(a)(3)(ii)
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form
2767
Sample Electronic Product
FDA_Form 2767 Sample Electronic Product.pdf
Yes
Yes
Fillable Printable
Form
2579
Report of Assembly of a Diagnostic XRay System
FDA Form 2579_Report of Assembly of a Diagnostic XRay System.pdf
Yes
Yes
Fillable Printable
Form
3147
Laser Light Show Variance Request Form
FDA_Form 3147 Laser Light Show Variance Request Form.pdf
Yes
Yes
Fillable Printable
Form
2877
Importation of Electronic Product
FDA_Form 2877_Importation of Electronic Product.pdf
Yes
Yes
Fillable Printable
Form
3626
Diagnostic X-Ray Systems and Components Product Report
FDA_Form 3626 Diagnostic X-Ray Systems and Components Product Report.pdf
Yes
Yes
Fillable Fileable
Form
3627
Diagnostic X-Ray CT Products Product Report
FDA_Form 3627 Diagnostic X-Ray CT Products Product Report.pdf
Yes
Yes
Fillable Printable
Form
3628
General Annual Report
FDA_Form 3628 General Annual Report.pdf
Yes
Yes
Fillable Printable
Form
3629
Abbreviated Report
FDA_Form 3629 Abbreviated Report.pdf
Yes
Yes
Fillable Printable
Form
3630
Sunlamp Product Report
FDA_Form 3630 Sunlamp Product Report.pdf
Yes
Yes
Fillable Printable
Form
3631
Sunlamp Products Annual Report
FDA_Form 3631 Sunlamp Products Annual Report.pdf
Yes
Yes
Fillable Printable
Form
3632
Lasers and Products Containing Lasers Product Report
FDA_Form 3632 Lasers and Products Containing Lasers Product Report.pdf
Yes
Yes
Fillable Printable
Form
3633
General Variance Request
FDA_Form 3633 General Variance Request.pdf
Yes
Yes
Fillable Printable
Form
3637
Laser Original Equipment Manufacturer Product Report
FDA_Form 3637 Laser Original Equipment Manufacturer Product Report.pdf
Yes
Yes
Fillable Printable
Form
3635
Laser Light Show Notification
FDA_Form 3635 Laser Light Show Notification.pdf
Yes
Yes
Fillable Printable
Form
3636
Lasers and Laser Light Show Annual Reports
FDA_Form 3636 Lasers and Laser Light Show Annual Reports.pdf
Yes
Yes
Fillable Printable
Form
3638
X-Ray Components and Systems Annual Report
FDA_Form 3638 X-Ray Components and Systems Annual Report.pdf
Yes
Yes
Fillable Printable
Form
3640
Laser Light Show Product Report
FDA_Form 3640 Laser Light Show Product Report.pdf
Yes
Yes
Fillable Printable
Form
3634
Television Products Annual Report.
FDA_Form 3634 Television Products Annual Report.pdf
Yes
Yes
Fillable Printable
Form
3639
Cabinet X-Ray Products Product Report
FDA_Form 3639 Cabinet X-Ray Products Product Report.pdf
Yes
Yes
Fillable Printable
Form
3641
Cabinet X-Ray Products Annual Report
FDA_Form 3641 Cabinet X-Ray Products Annual Report.pdf
Yes
Yes
Fillable Printable
Form
3642
General Correspondence
FDA_Form 3642 General Correspondence.pdf
Yes
Yes
Fillable Printable
Form
3643
Microwave Oven Products Annual Report
FDA_Form 3643 Microwave Oven Products Annual Report.pdf
Yes
Yes
Fillable Printable
Form
3644
Ultrasound Therapy Products Product Report
FDA_Form 3644 Ultrasound Therapy Products Product Report.pdf
Yes
Yes
Fillable Printable
Form
3645
Ultrasound Therapy Products Annual Report
FDA_Form 3645 Ultrasound Therapy Products Annual Report.pdf
Yes
Yes
Fillable Printable
Form
3646
Mercury Vapor Lamp Product Report
FDA_Form 3646 Mercury Vapor Lamp Product Report.pdf
Yes
Yes
Fillable Printable
Form
3647
Mercury Vapor Lamp Annual Report
FDA_Form 3647 Mercury Vapor Lamp Annual Report.pdf
Yes
Yes
Fillable Printable
Form
3649
Accidental Radiation Occurrence
FDA_Form 3649 Accidental Radiation Occurrence.pdf
Yes
Yes
Fillable Printable
Form
3659
Television Products Product Report
FDA_Form 3659 Television Products Product Report.pdf
Yes
Yes
Fillable Printable
Form
3660
Microwave Oven Product Report
FDA_Form 3660 Microwave Oven Product Report.pdf
Yes
Yes
Fillable Printable
Form
3661
Abbreviated Report for X-Ray Tables, etc.
FDA_Form 3661 Abbreviated Report for X-Ray Tables, etc.pdf
Yes
Yes
Fillable Printable
Form
3662
Abbreviated Report for Cephalometric Devices
FDA_Form 3662 Abbreviated Report for Cephalometric Devices.pdf
Yes
Yes
Fillable Printable
Form
3663
Abbreviated Report for Microwave Products
FDA_Form 3663 Abbreviated Report for Microwave Products.pdf
Yes
Yes
Fillable Printable
Form
3801
Medical UV lamps Product report
FDA_Form 3801 Medical UV lamps Product 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
4,162
0
0
4,162
0
0
Annual IC Time Burden (Hours)
235,767
0
0
235,767
0
0
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.