Medical Devices--Voluntary Improvement Program

ICR 202307-0910-005

OMB: 0910-0922

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
202307-0910-005
Received in OIRA
HHS/FDA CDRH
Medical Devices--Voluntary Improvement Program
New collection (Request for a new OMB Control Number)   No
Regular 07/31/2023
  Requested Previously Approved
36 Months From Approved
804 0
98 0
0 0

The Voluntary Improvement Program (VIP) is facilitated by the Medical Device Innovation Consortium (MDIC), a public-private partnership that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals. The VIP is intended to guide improvement to enhance the quality of medical devices. As part of the VIP process, FDA receives information about participating device manufacturers’ capability and performance for activities covered in third-party appraisals to enhance manufacturing and business practices in a way that improves the quality and safety of medical devices, benefitting patients and consumers. While appraisals performed through the VIP do not constitute a new regulatory requirement or serve as an equivalent to an FDA inspection, FDA may consider information from a participant’s appraisals, as appropriate, in risk-based inspection planning.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  87 FR 27165 05/06/2022
88 FR 45854 07/27/2023
Yes

3
IC Title Form No. Form Name
VIP - aggregate data reporting
VIP - site manufacturing applications
VIP - summary of site appraisal

  Total Request 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 804 0 0 804 0 0
Annual Time Burden (Hours) 98 0 0 98 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new information collection request.

$86,086
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@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.
07/31/2023


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