Premarket Approval of Medical Devices - 21 CFR Part 814

ICR 201912-0910-005

OMB: 0910-0231

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2019-12-16
Supporting Statement A
2017-01-31
IC Document Collections
ICR Details
0910-0231 201912-0910-005
Historical Active 201701-0910-017
HHS/FDA CDRH
Premarket Approval of Medical Devices - 21 CFR Part 814
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/30/2019
Retrieve Notice of Action (NOA) 12/16/2019
  Inventory as of this Action Requested Previously Approved
03/31/2020 03/31/2020 03/31/2020
5,268 0 5,268
357,736 0 357,736
0 0 0

This ICR collects information from persons filing a PMA application or a PMA supplement with FDA for approval of certain class III medical devices. The PMA regulation establishes procedures that FDA utilizes in approving, denying, or withdrawing approval of any PMA. It provides specific, clear, and flexible instructions to applicants so those respondents know what information is required in a PMA. PMA supplements are also used by FDA to determine any additional action the agency must take to protect the public health. The data reported to FDA and the records that are maintained allow FDA and industry to make decisions and take actions to protect the public health from defective medical devices.

US Code: 21 USC 360(e) Name of Law: FFDCA
   US Code: 21 USC 351(f) Name of Law: FFDCA
   US Code: 21 USC 515(d)(6) Name of Law: FFDCA
  
None

Not associated with rulemaking

  81 FR 72063 10/19/2016
82 FR 7839 01/23/2017
No

2
IC Title Form No. Form Name
Premarket Approval of Medical Devices - 21 CFR Part 814
Premarket Approval of Medical Devices: maintenance of records

  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 5,268 5,268 0 0 0 0
Annual Time Burden (Hours) 357,736 357,736 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have adjusted the number of respondents to reflect current Agency data for all the reporting ICs.

$33,451,466
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.
12/16/2019


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