Premarket Approval of Medical Devices - 21 CFR Part 814

ICR 202001-0910-010

OMB: 0910-0231

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-03-20
ICR Details
0910-0231 202001-0910-010
Active 201912-0910-005
HHS/FDA CDRH
Premarket Approval of Medical Devices - 21 CFR Part 814
Extension without change of a currently approved collection   No
Regular
Approved without change 03/25/2020
Retrieve Notice of Action (NOA) 03/20/2020
  Inventory as of this Action Requested Previously Approved
03/31/2023 36 Months From Approved 03/31/2020
5,542 0 5,268
392,518 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
  
None

Not associated with rulemaking

  84 FR 57030 10/24/2019
85 FR 7311 02/07/2020
No

2
IC Title Form No. Form Name
Premarket Approval of Medical Devices Reporting Requirements
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 5,542 5,268 0 0 274 0
Annual Time Burden (Hours) 392,518 357,736 0 0 34,782 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The following changes resulted in an adjustment in an overall total burden increase of 34,782 hours. -Added the burden estimate for “Information on clinical investigations conducted outside the United States (§ 814.20(b)(6)(ii)(C)),” which is associated with the “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices” final rule as described previously in this document. -Revised the burden description and table to reflect that the Expedited Access Pathway and Priority Review have been superseded by the Breakthrough Devices Program.

$31,895,990
No
    Yes
    No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 [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.
03/20/2020


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