Reclassification Petitions for Medical Devices

ICR 201806-0910-010

OMB: 0910-0138

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2018-08-20
IC Document Collections
ICR Details
0910-0138 201806-0910-010
Historical Active 201505-0910-006
HHS/FDA CDRH
Reclassification Petitions for Medical Devices
Extension without change of a currently approved collection   No
Regular
Approved without change 09/19/2018
Retrieve Notice of Action (NOA) 08/20/2018
  Inventory as of this Action Requested Previously Approved
09/30/2021 36 Months From Approved 09/30/2018
6 0 6
3,000 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 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

  83 FR 9743 03/07/2018
83 FR 39105 08/08/2018
Yes

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

  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

$1,754,298
No
    No
    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.
08/20/2018


© 2024 OMB.report | Privacy Policy