Reclassification Petitions for Medical Devices

ICR 201203-0910-009

OMB: 0910-0138

Federal Form Document

Forms and Documents
IC Document Collections
ICR Details
0910-0138 201203-0910-009
Historical Active 200903-0910-005
HHS/FDA
Reclassification Petitions for Medical Devices
Extension without change of a currently approved collection   No
Regular
Approved with change 06/19/2012
Retrieve Notice of Action (NOA) 03/29/2012
  Inventory as of this Action Requested Previously Approved
06/30/2015 36 Months From Approved 06/30/2012
6 0 6
3,000 0 3,000
0 0 0

This collection 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. The classification regulation, 21 CFR Part 860 including subpart C, reclassification, was promulgated under the authority of 21 U.S.C. 360(e) and (f), 360d(b), 360e(b), 360j(1), and 360i(b)(1)(A). The staff of the Center for Devices and Radiological Health (CDRH) is responsible for reviewing petitions for reclassification and determining whether the subject device will be reclassified. In some instances, FDA also submits such petitions to one of its medical device advisory panels for review and recommendations. FDA's decision regarding the reclassification of a device is based primarily upon the information contained in the petition.

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

Not associated with rulemaking

  76 FR 70460 11/14/2011
77 FR 17483 03/26/2012
No

1
IC Title Form No. Form Name
Reclassification Petitions for Medical Devices 3427, 3429 FDA Form 3427 ,   FDA Form 3429

  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) 3,000 3,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,277,718
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  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.
03/29/2012


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