Reclassification Petitions for Medical Devices

ICR 201812-0910-009

OMB: 0910-0138

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-01-26
IC Document Collections
IC ID
Document
Title
Status
5757
Modified
ICR Details
0910-0138 201812-0910-009
Active 201806-0910-010
HHS/FDA CDRH
Reclassification Petitions for Medical Devices
Revision of a currently approved collection   No
Regular
Approved with change 02/01/2019
Retrieve Notice of Action (NOA) 01/30/2019
  Inventory as of this Action Requested Previously Approved
02/28/2022 36 Months From Approved 09/30/2021
6 0 6
2,982 0 3,000
0 0 0

This ICR collects information from medical device manufactures who wish to request reclassification of a medical device. A manufacturer may petition the Agency to reclassify a device. The reclassification procedures regulation requires a manufacturer to submit specific data when petitioning for reclassification. This includes both a "supplemental data sheet" (Form FDA 3427) and a "classification questionnaire" (Form FDA 3429). Each of these forms contains a series of questions concerning the safety and effectiveness of the device type. The regulation requires device manufacturers to provide, in a petition for device reclassification, specification of the type of device, a statement of the action requested, and a justification for the request to reclassify.

US Code: 21 USC 360 ( e) ( f ) Name of Law: null
   US Code: 21 USC 360e (b) Name of Law: null
   US Code: 21 USC 360j(1) Name of Law: null
   US Code: 21 USC 360i(b)(1)(A) Name of Law: null
   US Code: 21 USC 360d(b) Name of Law: null
  
None

0910-AH75 Final or interim final rulemaking 83 FR 64443 12/17/2018

  79 FR 16252 03/25/2014
83 FR 64443 12/17/2018
Yes

1
IC Title Form No. Form Name
Reclassification Petitions for Medical Devices

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 6 6 0 0 0 0
Annual Time Burden (Hours) 2,982 3,000 0 0 -18 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,561,716
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
01/30/2019


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