De Novo Classification Process (Evaluation of Automatic Class III Designation)

ICR 201905-0910-006

OMB: 0910-0844

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-07-08
ICR Details
0910-0844 201905-0910-006
Active 201707-0910-009
HHS/FDA CDRH
De Novo Classification Process (Evaluation of Automatic Class III Designation)
Revision of a currently approved collection   No
Regular
Approved without change 08/06/2019
Retrieve Notice of Action (NOA) 07/11/2019
  Inventory as of this Action Requested Previously Approved
08/31/2022 36 Months From Approved 09/30/2020
185 0 57
10,730 0 7,330
7,283 0 0

The ICR describes the information collection involved with the De Novo classification process for medical devices. FDA uses the information in the De Novo request to evaluate whether the medical device may be reclassified from Class III to Class I or II, and if applicable, to determine the general and/or special controls necessary to sufficiently regulate the medical device. Respondents to the information collection are medical device manufacturers.

US Code: 21 USC 513 Name of Law: The FD&C Act
  
None

Not associated with rulemaking

  82 FR 50135 10/30/2017
84 FR 3160 07/02/2019
No

  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 185 57 0 0 128 0
Annual Time Burden (Hours) 10,730 7,330 0 0 3,400 0
Annual Cost Burden (Dollars) 7,283 0 0 0 7,283 0
No
No
Our estimated burden for the information collection reflects an overall increase of 3,400 hours. We attribute this adjustment to the addition of the Acceptance Checklist and the Recommended Content Checklist and to an increase in the number of submissions we received during the approval period.

$5,205,720
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
07/11/2019


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