Medical Devices--Voluntary Improvement Program

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
261289	VIP - summary of site appraisal	Other-Agency Guidance	Modified
261288	VIP - aggregate data reporting	Other-Agency Guidance	Modified
261287	VIP - site manufacturing applications	Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0922	ICR Reference No: 202609-0910-008
Status: Received in OIRA	Previous ICR Reference No: 202307-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices--Voluntary Improvement Program
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/02/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	604	0
Time Burden (Hours)	6,056	0
Cost Burden (Dollars)	0	0

---

Abstract: 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.

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 44852	07/17/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 62528	10/01/2026
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

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

---

ICR Summary of Burden

table that charts list of burden

	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	604	0	0	0	604	0
Annual Time Burden (Hours)	6,056	0	0	0	6,056	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Our estimated burden for the information collection reflects an overall decrease of 2,009 hours and a corresponding decrease of 200 responses. We attribute this adjustment based on our device registration and listing data and informal feedback from stakeholders. ROCIS reflects an increase in burden hours; however, this increase is not the result of any change to the information collection. Rather, it stems from the collection having been discontinued and FDA's current request for reinstatement of the previously approved collection.

---

Annual Cost to Federal Government: $76,388

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

---

Common Form ICR:  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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 10/02/2026

---