Premarket Approval of Medical Devices - 21 CFR Part 814

ICR 201311-0910-004

OMB: 0910-0231

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2013-11-07
IC Document Collections
IC ID
Document
Title
Status
5826
Modified
ICR Details
0910-0231 201311-0910-004
Historical Active 201212-0910-006
HHS/FDA 20884
Premarket Approval of Medical Devices - 21 CFR Part 814
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 11/20/2013
Retrieve Notice of Action (NOA) 11/12/2013
  Inventory as of this Action Requested Previously Approved
12/31/2013 12/31/2013 12/31/2013
2,050 0 2,050
100,870 0 100,870
0 0 0

The implementing regulations, contained in 21 CFR Part 814, specify the contents of a PMA for a medical device and the criteria FDA will employ in approving, denying, or withdrawing approval of a PMA and supplements to PMA's. The regulation's purpose is to establish an efficient and through procedure for FDA's review of PMA's and supplements to PMA's for class III (premarket approval) medical devices. The regulations also ensure the disapproval of PMA's and supplements to PMA's for devices that have not been show to be safe and effective and that do not otherwise meet the statutory criteria for approval.

US Code: 21 USC 205 Name of Law: null
   US Code: 21 USC 201 Name of Law: null
   US Code: 21 USC 202 Name of Law: null
   US Code: 21 USC 208 Name of Law: null
   US Code: 21 USC 209 Name of Law: null
  
None

Not associated with rulemaking

No

1
IC Title Form No. Form Name
Premarket Approval of Medical Devices - 21 CFR Part 814

  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 2,050 2,050 0 0 0 0
Annual Time Burden (Hours) 100,870 100,870 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$31,116,600
No
No
No
No
No
Uncollected
JonnaLynn Capezzuto 301 827-4659 [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.
11/12/2013


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