Contains Nonbinding Recommendations
Fostering Medical Device 
Improvement: FDA Activities and 
Engagement with the Voluntary 
Improvement Program
Guidance for Industry and
Food and Drug Administration Staff
Document issued on September 15, 2023
The draft of this document issued on May 6, 2022.
For questions about this document, contact Compliance and Quality Staff within OPEQ:Office of 
Product Evaluation and Quality/IO:Immediate Office at CaseforQuality@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
OMB Control No. 0910-0922
Current expiration date available at https://www.reginfo.gov
See additional PRA statement in Section VI of this guidance. Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-
1740. Identify all comments with the docket number FDA-2022-D-0109. Comments may not be 
acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet.  You may also send an email request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number GUI00020039 and complete title of the guidance in the request. Contains Nonbinding Recommendations
Table of Contents
I.  Introduction .......................................................................................................................... 1
II.  Background .......................................................................................................................... 2
III.  Program Features ................................................................................................................. 3
IV.  Voluntary Improvement Program Operations ..................................................................... 5
VIP Eligibility .................................................................................................................. 5 
  Additional Eligibility Considerations............................................................................... 6 
  VIP Participating Manufacturing Site Expectations ........................................................ 6 
  VIP Process Flow ............................................................................................................. 7 
V. FDA Activities and Engagement with VIP .......................................................................... 8 
  FDA Commitment to VIP Participating Manufacturing Sites ......................................... 8 
  Existing Regulatory Obligations and FDA Involvement ................................................. 9 
  Withdrawal and Removal from the VIP After Acceptance.............................................. 9 
VI. Paperwork Reduction Act of 1995 ..................................................................................... 10 
Appendix A: Modified Submission Formats ................................................................................ 12
Appendix B: Performance Measures Example ............................................................................. 16 Contains Nonbinding Recommendations
Fostering Medical Device 
Improvement: FDA Activities and 
Engagement with the Voluntary 
Improvement Program
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I. Introduction 
The FDAs Center for Devices and Radiological Health (CDRH) is issuing this guidance to 
describe its policy regarding participation in the Voluntary Improvement Program (VIP). The 
VIP is a voluntary program facilitated through the Medical Device Innovation Consortium 
(MDIC) that evaluates the capability and performance of a medical device manufacturers 
practices using third-party appraisals, and is intended to guide improvement to enhance the 
quality of devices. The VIP builds on the framework piloted through FDAs 2018 Case for 
Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot 
Program)1 andincorporates some of the successes and learnings from the pilot.2 The VIP is only 
available to eligible manufacturers of medical devices regulated by CDRH and whose marketing 
applications are reviewed under the applicable provisions of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (including under sections 510(k), 513, 515, and 520). 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.
1See 82 FR 61575.
2Please refer to the Case for Quality Pilot Report for additional information regarding the outcomes of the pilot 
program: https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/case-quality-pilot-
activities.
1 Contains Nonbinding Recommendations
II. Background 
As captured in CDRH's 2016-2017 strategic priority to Promote a Culture of Quality and 
Organizational Excellence,3 CDRH envisions a future where the medical device ecosystem is 
inherently focused on device features and manufacturing practices that have the greatest impact 
on product quality and patient safety. Among its other regulatory activities, FDA evaluates 
manufacturers' compliance with regulations governing the design and production of devices. 
Compliance with the Quality System Regulation, 21 CFR Part 820, is a baseline requirement for 
medical device manufacturing firms.4
In an effort to elevate and enhance manufacturing practices and behaviors through which quality 
and safety of medical devices can be improved, FDA collaborated with various stakeholders, 
brought together through the MDIC public-private partnership, to develop the CfQ Pilot 
Program. FDA announced the voluntary Pilot Program in the Federal Register on December 28, 
2017 (82 FR 61575). Details and results from the 2018 CfQ Pilot Program are outlined in 
MDICs Case for Quality Pilot Report.5
As in the CfQ Pilot Program, the VIP oversees third-party appraisers who evaluate voluntary 
industry participants, and the VIP assesses the capability and performance of key business 
processes using a series of integrated best practices. The practices are detailed in the Information 
Systems Audit and Control Association (ISACA) Capability Maturity Model Integration 
(CMMI) system. CMMI provides a roadmap that guides improvement towards disciplined and 
consistent processes for achieving key business objectives, including quality and performance. 
The VIP uses a version of the CMMI appraisal appropriate for the medical device industry.6 This 
appraisal tool is referred to as the Medical Device Discovery Appraisal Program (MDDAP) 
model.7 The baseline appraisal using the MDDAP model covers 11 practice areas, such as 
Governance, Implementation Infrastructure, and Managing Performance and Measurement. 
Participants may adjust the practice areas on the subsequent appraisals compared to the baseline 
set to better align with the organizational improvement goals. As part of the VIP, and as in the 
32016-2017 Strategic Priorities: Center for Devices and Radiological Health, available at 
https://www.fda.gov/media/95317/download.
4On February 23, 2022, FDA proposed to amend the device QS regulation, 21 CFR part 820, to align more closely 
with international consensus standards for devices (87 FR 10119; available at 
https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-
amendments). Specifically, FDA proposed to withdraw the majority of the current requirements in part 820 and 
instead incorporate by reference the 2016 edition of the International Organization for Standardization (ISO) 13485, 
Medical devices- Quality management systems for regulatory purposes, in part 820. As stated in that proposed rule, 
the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the current 
part 820, providing a similar level of assurance in a firms quality management system and ability to consistently 
manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act. FDA intends to 
finalize this proposed rule expeditiously. When the final rule takes effect, FDA will also update the references to 
provisions in 21 CFR part 820 in this guidance to be consistent with that rule.
5The Case for Quality Pilot Report is available at: https://www.fda.gov/medical-devices/quality-and-compliance-
medical-devices/case-quality-pilot-activities.
6 Information about the CMMI system is available at: https://cmmiinstitute.com/.
7For additional information on the MDDAP, please see https://www.isaca.org/enterprise/medical-device-discovery-
appraisal-program. 
2 Contains Nonbinding Recommendations
CfQ Pilot Program, the program provides firms and FDA with information about the firms 
capability and performance for activities covered in the third-party appraisal.
III. Program Features 
The VIP is a third-party quality maturity appraisal and continuous improvement program 
facilitated through the MDIC, which was developed to improve medical device design, 
production, and quality. The VIP is a voluntary program, not a regulatory requirement. The VIP 
evaluates a participating manufacturers capability and performance in key business processes by 
having qualified, third-party appraisers discuss, observe, and review the participant firms 
practices. The appraisers evaluate the firms practices for the business processes established in 
the appraisal scope against the integrated best practices within the CMMI model. Then, based on 
the third-party appraisers evaluation of a participants practices, the VIP identifies the firms 
strengths and potential opportunities for improvement. The VIP allows the third-party appraiser 
to share some of that information with FDA. For example, the Agency receives high-level 
appraisal scores for each assessed practice area, by firm name and location, as well as de-
identified, aggregate information from the program. 
 
The site visit and/or analysis is not intended to be a regulatory inspection or an audit, and 
appraisers do not assess the firms compliance with applicable regulatory standards. As part of 
the appraisal process, appraisers may review relevant information including, but not limited to, 
documents and systems, and conduct interviews. Appraisers do not make regulatory observations 
or findings. Although the VIP produces information conveyed to both the firm and to FDA, it 
does not issue a rating or a certification.
Participating manufacturing sites who demonstrate ongoing engagement with the program and 
sustained or improved capabilities and performance, may benefit from several opportunities that 
the VIP offers, following FDAs review of the sites appraisal, including:
 Opportunity for FDA Consideration in Risk-Based Inspection Planning  Section 701 
of the FDA Reauthorization Act of 2017 (FDARA) amended section 510(h)(2) of the 
FD&C Act to require FDA inspections of device establishments to occur in accordance 
with a risk-based schedule established by the Secretary. In establishing such a schedule, 
section 510(h)(4) requires FDA to consider the following factors: (1) the compliance 
history; (2) the record, history, and nature of recalls linked to the establishment; (3) the 
inherent risk of the device manufactured, prepared, processed at the establishment; (4) the 
inspection frequency and history of the establishment, including whether the 
establishment has been inspected pursuant to section 704 within the last 4 years; (5) 
whether the establishment has been inspected by a foreign government or agency 
recognized under section 809;  and (6) any other criteria deemed necessary and 
appropriate by the Secretary for the purposes of allocating inspection resources.  
 
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 participants appraisals, as appropriate, in risk-based inspection
3 Contains Nonbinding Recommendations
planning. FDA retains the inspection authority granted under the FD&C Act and may 
conduct inspections at VIP sites, including, but not limited to surveillance, premarket, or 
for cause inspections as appropriate. 
 Opportunity to Utilize a Modified Submission Format for Premarket Approval 
Application (PMA) and Humanitarian Device Exemption (HDE) 30-Day Change 
Notices for Modifications to Manufacturing Procedures or Methods of Manufacture  
FDA intends to offer participating manufacturing sites the opportunity to submit 30-Day 
Change Notices for modifications to manufacturing procedures or methods of 
manufacture using a modified submission format. See Appendix A for additional 
information regarding content of the modified submission format. FDA intends to review 
changes related to quality improvements within 10 calendar days as resources permit. 
When appropriate, FDA may use the full 30-Day review time and, when such notice is 
inadequate, FDA intends to inform the applicant that a 135-Day PMA supplement or 75-
Day HDE supplement must be submitted as defined by section 515(d)(5)(A) of the 
FD&C Act and 21 CFR 814.39(f) and 814.108. For more information generally regarding 
30-Day Change Notices please refer to FDAs guidance titled 30-Day Notices, 135-Day 
Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption 
(HDE) Supplements for Manufacturing Method or Process Changes.8
 Opportunity to Utilize a Modified Submission Format for PMA and HDE 
Manufacturing Site Change Supplements  FDA intends to offer participating 
manufacturing sites the opportunity to submit 180-Day PMA or 75-Day HDE 
Manufacturing Site Change Supplements using a modified submission format. See 
Appendix A for additional information regarding content of the modified submission 
format. FDA intends to review such supplements as resources permit within 25 calendar 
days. The site change should be to a site already accepted into the VIP. When 
appropriate, upon notification to the applicant, FDA may use the full 180-Day or 75-Day 
review time as defined by section 515(d)(5)(A)(i) of the FD&C Act and 21 CFR 
814.39(a)(3), 814.108, and 814.114. For more information generally regarding 180-Day 
PMA or 75-Day HDE Manufacturing Site Change Supplements please refer to FDAs 
guidance titled Manufacturing Site Change Supplements: Content and Submission.9
 Opportunity to Utilize a Modified Submission Format for PMA or HDE - 
Manufacturing Modules  FDA intends to offer participating manufacturing sites the 
opportunity to submit manufacturing modules for a PMA or HDE using a modified 
submission format for review by FDA staff. See Appendix A for additional information 
regarding content of the modified submission format. For more information generally 
regarding the submission format for PMA or HDE manufacturing modules please refer to 
8https://www.fda.gov/regulatory-information/search-fda-guidance-documents/30-day-notices-135-day-premarket-
approval-pma-supplements-and-75-day-humanitarian-device-exemption
9https://www.fda.gov/regulatory-information/search-fda-guidance-documents/manufacturing-site-change-
supplements-content-and-submission
4 Contains Nonbinding Recommendations
FDAs guidance titled Quality System Information for Certain Premarket Application 
Reviews.10
FDA aims to remain agile and continue to actively engage with MDIC to improve processes, 
features, and potential opportunities to participate in the VIP as the program generates new data 
and the program evolves. FDA may provide examples, share lessons learned, or expand 
innovative approaches with the participating organizations in order to continue to improve the 
effectiveness and efficiency of the VIP. 
IV. Voluntary Improvement Program Operations  
The VIP currently uses the Medical Device Discovery Appraisal Program (MDDAP), which is a 
tailored version of CMMI Performance Solutions, to evaluate the capabilities and performance of 
the medical device manufacturer's current business processes and objectives against the best 
practices outlined by the maturity model. While the VIP does not evaluate compliance with any 
regulatory requirements, the manufacturers business processes are evaluated to determine if they 
support ongoing achievement of business objectives, including quality improvements. The 
MDDAP program is administered by ISACA11, which also certifies and coordinates third-party 
appraisers, maintains the detailed results of the appraisals, and evaluates the collected data. 
ISACA is an independent body and has established certification procedures to prevent conflicts 
of interest for the third-party appraisers. To establish the scope of the appraisal, the appraisal 
team12 is expected to meet with participants staff and obtain information regarding work units, 
products manufactured, the number of employees, and the manufacturing volume. Appraisers use 
this information to help determine the evaluation strategy and appropriate sampling across 
products and processes. Appraisers may also use this information to evaluate the participants 
business processes by comparing how participant manufacturers meet the best practices outlined 
by the maturity model. The appraisal team may use such information to identify opportunities to 
improve. This is intended to provide the participating manufacturer with data and granularity that 
reflects its own organizational performance against the practices outlined in the maturity model, 
and a roadmap to improve performance, increase quality, and enhance value. FDA also benefits 
by receiving a summary of the individual firms information and aggregated information across 
all participating manufacturers. Additional details of the process for MDDAP appraisals can be 
found at https://www.isaca.org/enterprise/medical-device-discovery-appraisal-program#mddap-
three-simple-steps. Finally, FDA understands that there are other potentially viable appraisal 
programs and may consider assessing those programs and their suitability for future use in the 
VIP.
VIP Eligibility  
10https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-system-information-certain-
premarket-application-reviews
11Information regarding the ISACA Medical Device Discovery Appraisal Program is available at: 
https://www.isaca.org/mddap.
12The appraisal team is comprised of a lead appraiser, who serves as the designated representative for the team, and 
additional appraisal team members determined by the scope of the appraisal, size of the participating organization, 
and appraisal duration.
5 Contains Nonbinding Recommendations
The program has established enrollment and participation criteria for manufacturing sites. To 
participate in VIP, manufacturing sites should meet specified enrollment criteria. Manufacturing 
sites are also expected to meet additional participation criteria, including an MDDAP appraisal. 
Both the enrollment and participation criteria are available at 
https://www.isaca.org/enterprise/medical-device-discovery-appraisal-program#mddap-three-
simple-steps. FDA intends to review and confirm an applicants eligibility for enrollment in the 
VIP. Any current CfQ Pilot Program participants who wish to participate in the VIP do not need 
to reapply and are considered enrolled in the VIP unless they express an intention to withdraw 
(and subject to the principles outlined in Section V.C. below).
If a manufacturing site believes that it meets the enrollment criteria and would like to be 
considered for participation in the VIP, it may apply at 
http://medicaldevice.enrollment.sgizmo.com/s3/. 
If you have questions regarding enrollment, contact FDA at CaseforQuality@fda.hhs.gov.
Additional Eligibility Considerations  
Generally, to be eligible for the VIP, a manufacturer is expected to have a history of being in 
compliance with the applicable requirements of the FD&C Act and its implementing regulations. 
To make that determination, FDA may consider the firms inspectional history, and, if 
applicable, other relevant information. On a case-by-case basis, VIP may consider enrolling 
manufacturing sites that do not have previous compliance history with the Agency, including for 
example: manufacturers that may not be responsible for complying with 21 CFR Part 820 (i.e., 
component manufacturers) and/or firms that do not meet all of the eligibility factors outlined 
above. These companies may be able to benefit from the VIP by building capability in their 
employees and processes and focusing on continuous improvement in the same way as the 
companies that have established a good compliance standing with the Agency. These companies 
may not be eligible for certain opportunities offered under the program, as noted in Section III 
above, until FDA has verified the manufacturer is in compliance with the FD&C Act and its 
implementing regulations.
VIP Participating Manufacturing Site Expectations 
The VIP anticipates that participating manufacturing sites:
 Receive an annual appraisal. 
 
 Engage with appraisers and commit to the mutually agreed upon appraisal process.13
o  Appraisers are encouraged to stop the appraisal at any time in the process if a 
manufacturer does not engage as the appraiser expects, or if the manufacturer fails 
to follow any of the appraisal process boundaries and expectations, mutually 
agreed upon during the appraisal scoping. The appraiser may follow its 
established process with the VIP, which may involve FDA. 
13See https://www.isaca.org/enterprise/medical-device-discovery-appraisal-program
6 Contains Nonbinding Recommendations
 Perform a quarterly progress check-in with lead appraisers. 
 Submit quality performance measures according to the criteria set forth in the CMMI 
system and appraisal method. These measures fall into quality domains such as safety, 
effectiveness, reliability, and availability, but VIP does not prescribe individual 
performance measures, only that they be relevant to participants. Information provided by 
the participants establishes context for a given performance measure, including:
 the quality objective of the measure
 business objective of the measure
 name or title of the measure
 the level of the measure (e.g., product, aggregate, site)
 how the measure is calculated
 indications of improving performance
 known limitations of the measure or data
 why the measure matters/how the measure is used
 how often the measure is captured
 how often the measure is reported within the organization (i.e., daily, monthly, 
quarterly)
Please refer to Appendix B for an illustrative example of how participants could define 
this performance measure information.
 Proactively notify FDA regarding product safety issues or recalls following all current 
regulatory requirements, including reporting (see also Section V.B. below). 
 
  VIP Process Flow 
The process flow for participation in the VIP is as follows:
 Manufacturing sites apply to participate in the VIP through the application portal at 
http://medicaldevice.enrollment.sgizmo.com/s3/.
 The manufacturing sites application information is provided to FDA by the recognized 
third-party appraisal program. FDA intends to review a manufacturing site application 
within 5 calendar days and provide confirmation to the manufacturing site and the 
recognized third-party appraisal program of eligibility for participation in the VIP. If 
FDA does not agree that the manufacturing site has met the eligibility criteria for 
enrollment, the site will be notified accordingly.
7 Contains Nonbinding Recommendations
 The third-party appraisal program notifies FDA when a contract for appraisal between 
recognized third-party appraisal program and the participating manufacturing site has 
been established and provides FDA with the appraisal schedule.14
 The participating manufacturing site and the recognized third-party appraisal program are 
expected to scope, coordinate, and execute the appraisal. Appraisals are targeted to be 
conducted within 90 calendar days from confirmation of enrollment.
 Recognized third-party appraisal program provides FDA appraisal summary within 30 
calendar days of completing appraisal. 
 Participating manufacturing site meets quarterly with lead appraiser for progress checks 
and provides quality performance metrics.
 Participating manufacturing site and recognized third-party appraisal program plan and 
schedule follow-up appraisal activities on an annual basis.
 FDA may consider recommendations from recognized third-party appraisal programs 
regarding frequency of these activities (appraisals, check-ins, and submission of quality 
performance measures) as participants demonstrate continuing engagement, increased 
performance, or capability in their business process.
V.  FDA Activities and Engagement with VIP  
FDA maintains representation on the VIP governance committee and provides input to overall 
program operation and changes. This ensures that VIP continues to align with FDAs 
expectations of improving participating manufacturing sites capability and performance and that 
VIP provides value to industry stakeholders. VIP establishes information that a recognized third-
party appraisal program should provide FDA, and that FDA intends to consider in the benefit-
risk considerations FDA routinely uses to inform planning and FDA resource allocations, 
improve review efficiency, and may inform risk-based inspection planning, for firms that 
demonstrate capability and transparency around their manufacturing and product performance. 
 
  FDA Commitment to VIP Participating Manufacturing 
Sites 
In response to the commitment by the participating manufacturing site to meet VIP expectations 
(Section IV.C) and to foster continuous improvement, safety, and transparency, FDA intends to:
 Engage proactively with participating manufacturing sites to resolve any issues (such as 
signals, potential safety issues, or recalls) according to the principles outlined in Section 
V.B. (Existing Regulatory Obligations and FDA Involvement).
14ISACA will work with the manufacturer to help determine scoping, schedule, and the logistics of the appraisal 
process.
8 Contains Nonbinding Recommendations
 Contact and engage with participating manufacturing sites to discuss and resolve any 
issues brought to FDAs attention during an appraisal. If there is no resolution for such 
issues, the appraisal should end, and the participant may no longer continue to participate 
in the program. Please see Section V.C. below for information regarding withdrawal and 
removal of participants from the VIP.
Existing Regulatory Obligations and FDA Involvement 
Participation in the VIP does not alter a firms existing regulatory obligations under the FD&C 
Act, nor does it impact FDAs enforcement authority under the FD&C Act. As is always the 
case, the Agency retains discretion to take enforcement action when appropriate. FDA retains the 
inspection authority granted under the FD&C Act and may conduct inspections at VIP sites, 
including, but not limited to surveillance, premarket, or for cause inspections as appropriate. 
Participants are responsible for complying with all applicable laws and regulations, including the 
FD&C Act and its implementing regulations (including, but not limited to, 21 CFR 803, 806, 
807, and 820). Information obtained through the course of the VIP is not intended to be a 
substitute for evidence collected during the course of an FDA inspection.
If issues (such as safety) are brought to FDAs attention during a firms participation in the VIP 
program, FDA intends to collaborate with participating manufacturing sites first to mitigate the 
impact of the issue, then to identify and to implement the most effective and efficient resolution 
which may include an action plan and regular communication. In addition to notifying the 
relevant FDA Medical Device Program Division, the participating manufacturing site should also 
contact the review team in the appropriate Office of Health Technology (OHT) within CDRHs 
Office of Product Evaluation and Quality (OPEQ), as well as the Case for Quality team at 
CaseforQuality@fda.hhs.gov, to facilitate working interactively with FDA to address the 
identified issues that may impact participation in VIP.
If FDA, in its discretion, determines that there has been significant and satisfactory progress 
towards resolution or it has been completed in the established timeline, no additional action is 
recommended from a VIP perspective and program opportunities available to participants 
continue. However, if FDA, in its discretion, determines that there has not been significant and 
satisfactory progress towards a resolution or the issue escalates into a serious injury or 
death, FDA may consider limiting program opportunities and/or recommending removal from 
participation in VIP as outlined in Section C below. 
Withdrawal and Removal from the VIP After Acceptance 
The VIP is a voluntary program and participants may choose to withdraw from participation at 
any time by providing notice to the recognized third-party appraisal program or by notifying 
FDA at CaseforQuality@fda.hhs.gov. Withdrawal from the VIP may affect the opportunities 
provided by FDA (as identified in Sections III and IV of this guidance). Participants who 
withdraw from the VIP may be eligible to enroll again at a later time.
9 Contains Nonbinding Recommendations
FDA and VIP participants have a shared goal to proactively and quickly address quality issues or 
safety risks that arise during program participation through collaboration and communication. 
FDA may remove participating manufacturing sites from the VIP if participants do not engage 
with FDA on certain issues as noted in Section V.B., or for any other reason that FDA 
determines is in the best interest of the public health.
A participating manufacturing site in the VIP who may not be fulfilling the expectations or 
commitments, such as by,
 missing a check point or delaying the checkpoint by greater than 60 calendar days 
without communication with the third-party appraiser;
 not providing performance measures or delaying performance measures by greater than 
60 calendar days without communication with the third-party appraiser;
 delaying appraisal or reappraisal by greater than 90 calendar days without 
communication and agreement by FDA;
 providing false or misleading information; or
 not fulfilling financial commitments to the third-party appraiser or delaying payments by 
greater than 30 calendar days unless otherwise agreed on by the third-party appraiser
may be subject to principles outlined in Section V.B., and, if appropriate, may have their 
eligibility for the program opportunities noted above (Section III) suspended for a period of time 
depending upon the issues identified, until the VIP determines that the participant is progressing 
sufficiently towards resolving these issues. If the participant and FDA cannot resolve any such 
issues by utilizing the principles and procedures described in Section V.B. of this guidance, FDA 
may recommend a participants removal from the VIP. Typically, participants who have been 
removed from the VIP may not be eligible to enroll in the program again until any outstanding 
issues have been resolved and verified by FDA.
VI. Paperwork Reduction Act of 1995  
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521).
The time required to complete this information collection is estimated to average 28 hours 
(rounded). Send comments regarding this burden estimate or suggestions for reducing this 
burden to:
FDA PRA Staff, Office of Operations,
Food and Drug Administration,
PRAStaff@fda.hhs.gov
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. The OMB control number 
10 Contains Nonbinding Recommendations
for this information collection is 0910- 0922 (To find the current expiration date, search for this 
OMB control number available at https://www.reginfo.gov).
11 Contains Nonbinding Recommendations
Appendix A: Modified Submission Formats
Through guidance documents, FDA has made recommendations for some information that would 
be useful to include in certain submission types (i.e., PMA/HDE 30-Day Change Notices, 
PMA/HDE Manufacturing Site Change Supplements, PMA/HDE Manufacturing Modules). FDA 
anticipates that, in the course of the VIP, it will gain insights into the participants manufacturing 
processes and control capabilities that would likely address some recommendations for these 
regulatory submissions. Thus, participants in the VIP may be able to avail themselves of 
efficiencies that might prevent duplicate information and/or allow for least burdensome 
submissions15 to the FDA.
30-Day Change Notice Submissions
Recommendations for content to be included in a 30-Day Change Notice are listed in FDAs 
guidance titled 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day 
Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process 
Changes.16 FDA anticipates that, during the course of the VIP, participants may provide FDA 
with information that will likely address some FDA recommendations regarding 30-Day Change 
Notices. The results of the appraisal and the VIP performance metrics may provide FDA with an 
understanding of the participating sites control capabilities and sufficient assurances to make a 
knowledgeable judgment about the quality control used in the manufacture of the device. FDA 
has created a modified submission format available to VIP participants for addressing the 
remainder of those recommendations.
 The VIP appraisal evaluates the participating sites capability to support, manage, 
sustain, and improve its established processes. As such, FDA intends to offer VIP 
participants the opportunity to use a modified submission format which does not 
recommend: 
 
 A summary of the procedures established for the identification, documentation, 
validation, review, and approval of the manufacturing changes submitted in the 
30- day notice. 
 A description of how you will monitor and control any manufacturing process you 
intend to change.
 Within the summary of the completed validation study that demonstrates that the 
manufacturing change can be made without significantly changing the operation 
of the final device, an explanation of how change control procedures were 
implemented, including whether the submitter modified the manufacturing or 
quality control instructions, or the manufacturing specifications.
 A summary of how purchasing control procedures were implemented to evaluate 
any new supplier or contractor, if the manufacturing change involves changes in 
15FDA defines least burdensome to be the minimum amount of information necessary to adequately address a 
relevant regulatory question or issue through the most efficient manner at the right time. See also The Least 
Burdensome Provisions: Concept and Principles, available at https://www.fda.gov/regulatory-information/search-
fda-guidance-documents/least-burdensome-provisions-concept-and-principles. 
16https://www.fda.gov/regulatory-information/search-fda-guidance-documents/30-day-notices-135-day-premarket-
approval-pma-supplements-and-75-day-humanitarian-device-exemption
12 Contains Nonbinding Recommendations
suppliers of components or raw materials that are critical to the performance of 
the device, or the use of a new contractor for a manufacturing process or quality 
control testing.
 A description of the type and extent of control to be exercised over the component 
or raw material, including specifications for the incoming material and a 
description of in-coming acceptance activities. Also, a description of any testing 
that was completed to evaluate the use of the component or material and include 
a summary of the data.
 During the course of the VIP, the appraisal is expected to evaluate sampling methods. As 
such, FDA intends to offer VIP participants the opportunity to use a modified submission 
format which does not recommend: 
 
 the statistical rationale for the sampling method, if the submitter plans to verify 
the changed processes by routine sampling and independent measurement. 
 
 Other FDA recommendations from the guidance may also be addressed as follows: 
 
 A description of the device may be replaced by the Device Identifier (DI), as 
applicable. 
 An identification of the manufacturing facilities where the change will be 
implemented may be captured through the FEI and CMMI Appraisal Numbers. 
 
PMA/HDE Manufacturing Site Change Supplement
Recommendations for content to be included in a PMA or HDE Manufacturing Site Change 
Supplement are listed in FDAs guidance titled Manufacturing Site Change Supplements: 
Content and Submission.17FDA anticipates that, during the course of the VIP, participants may 
provide FDA with information that will likely address some FDA recommendations regarding 
Manufacturing Site Change Supplements. The results of the appraisal and the VIP performance 
metrics may provide FDA with an understanding of the participating sites control capabilities 
and sufficient assurances to make a knowledgeable judgment about the quality control used in 
the manufacture of the device. FDA has created a modified submission format available to VIP 
participants for addressing the remainder of those recommendations.
 The VIP appraisal evaluates the participating sites capability to support, manage, 
sustain, and improve their established processes. As such, FDA intends to offer VIP 
participants the opportunity to use a modified submission format which does not 
recommend: 
 
 If the manufacturing site change results in the use of a different supplier or 
contract manufacturer, within the current purchasing control procedures 
detailing the supplier evaluation process: 
 
17https://www.fda.gov/regulatory-information/search-fda-guidance-documents/manufacturing-site-change-
supplements-content-and-submission
13 Contains Nonbinding Recommendations
How the submitter maintains records of acceptable suppliers and how the submitter 
addresses the purchasing data approval process.
 How the submitter balances purchasing assessment and receiving 
acceptance to ensure that products conform to specified requirements. 
 
Additionally, based upon review of control capabilities as part of the VIP appraisal, FDA 
intends to offer VIP participants the opportunity to use a modified submission format 
which does not recommend the following for processes that are consistent across 
manufacturing sites:
 A description of the equipment and processes that would be affected by the site 
change.
 A list of any standards used in the new manufacturing processes, if applicable
 The process validation or revalidation procedures (and reports, if applicable)
 The procedures for environmental and contamination controls if such conditions 
could adversely affect the device (21 CFR 820.70).
 If different from the original PMA, any procedures that explain how inspection, 
measuring, and test equipment are routinely calibrated, inspected, checked, and 
maintained (21 CFR 820.72). If this involves a large number of procedures, a 
sample of the most relevant procedures would be sufficient. If procedures are the 
same as those contained and approved in the original PMA, the submitter should 
provide a statement indicating this.
 The procedures for the incoming acceptance activities at the subject 
manufacturing site, if different from the procedures contained and approved in 
the original PMA. If procedures are the same as those contained and approved in 
the original PMA, the submitter should provide a statement indicating this. 
 The procedures for the final acceptance activities at the subject manufacturing 
site, if applicable and different from the procedures contained and approved in 
the original PMA. If procedures are the same as those contained and approved in 
the original PMA, the submitter should provide a statement indicating this.
However, if processes differ from the original manufacturing site, FDA may continue to 
recommend one or more of the previously listed elements.
 FDA anticipates reviewing a VIP participants master plan as a part of a manufacturing 
site change supplement. As such, FDA intends to offer VIP participants the opportunity 
to use a modified submission format which does not recommend:
 A list of processes at the new site that the submitter does not plan to validate but 
will verify by inspection and test.
 Other FDA recommendations may also be addressed as follows:
14 Contains Nonbinding Recommendations
 A description of the device [...] may be replaced by the Device Identifier (DI), as 
applicable.
 The FEI and CMMI Appraisal Numbers may also be useful to identify the site. 
PMA/HDE Original Manufacturing Module
Recommendations for content to be included in a PMA or HDE Original Manufacturing Module 
are listed in FDAs guidance titled Quality System Information for Certain Premarket 
Application Reviews.18FDA anticipates that, during the course of the VIP, participants may 
provide FDA with information that will likely address some FDA recommendations regarding 
PMA/HDE Original Manufacturing Modules. Because participation in the VIP depends upon 
FDAs verification that the manufacturer complies with the FD&C Act and its implementing 
regulations, FDA anticipates that the recommendations regarding information to provide about 
the design control process (i.e., recommendations under 21 CFR 820.30) will likely have already 
been verified and reviewed accordingly. Additionally, the results of the appraisal and the VIP 
performance metrics may provide FDA with an understanding of the participating sites control 
capabilities and sufficient assurances to make a knowledgeable judgment about the quality 
control used in the manufacture of the device. FDA has created a modified submission format 
available to VIP participants for addressing the remainder of those recommendations.
 FDA anticipates that the following recommendation from the guidance will likely be 
addressed for VIP participants based upon their inspection/audit history:
 You should provide a copy of your basic quality system procedure(s). 
 Several items may only continue to be recommended from VIP participants if the 
processes or procedures for controls have changed since last FDA review. This includes 
information regarding:
 Production and Process Controls, 21 CFR 820.70
 Inspection, Measuring, and Test Equipment, 21 CFR 820.72
 Receiving Acceptance Activities, 21 CFR 820.80(b)
 Final Acceptance Activities, 21 CFR 820.80(d)
 Nonconforming Products, 21 CFR 820.90
 Complaint Files, 21 CFR 820.198 
 Servicing, 21 CFR 820.200
The Device Identifier (DI), as applicable, and FEI and CMMI Appraisal Numbers may also be 
useful to describe the device and identify the site, respectively. 
18https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-system-information-certain-
premarket-application-reviews
15 Contains Nonbinding Recommendations
Appendix B: Performance Measures Example
The following table is an example of how a participant may define its performance measures. 
VIP expects that participants will provide appraisers, who will then in turn provide FDA, with 
these, or other, definitions, and provide FDA with data quarterly, as described above in Section 
IV.C. 
Performance Measure  Quality Domain
Information Safety Reliability Availability Effectiveness
(Device does not compromise  (Device system or  (Device is available to  (Device produces the 
the clinical condition or the  component is able to  fill first request  effect intended by the 
safety of patients, or the safety  function under stated  orders.) manufacturer relative to 
and health of users.) conditions for a  the medical 
specified period of  condition(s).)
time.)
Quality  Reduce Field Actions Product is serviced  Demonstrate ability to  Continuously improve 
correctly, the first time  operate in a full state  the safety and reliability 
it is serviced of control of our products
Business  Improved patient safety and  Develop, test, and  Customers orders are  Improve patient health 
customer experience maintain products that  filled completely and  and contribute to better 
consistently meet  on time, every time. quality of life
customer and business 
expectations
Title Number of Field Actions First Pass Yield Backorder Complaint Rate (CRR)
(as reported)
On Time and In Full 
(OTIF) Compliant Incidents per 
Million (CIPM)
Level  Product Aggregate across all  Aggregate across all  Aggregate across all 
products at site products for entire site products at site
How Calculated Count of actions taken on  Percentage of passing  Backorder Over (BO)  Sum of the quantity of 
products outside of  final serviced units  Days of Sales = (90  complaint incidents 
distribution control compared to total units  Days Average)
serviced Incidents as related to 
Order w/o BO, w/o  units released
complaints / Shipped 
= 30 Days Average
Indication of good  The value decreases with  The value increases Backorder:  The value decreases
performance target of 0 Decreasing from 
target 
OTIF: Increasing from 
target
Limitations or blind  None identified None identified None identified None identified
spots
Why the measure  Helps identify necessary  Helps identify  Ensure our customers  Helps identify necessary 
matters/How is it used product changes/reviewed  necessary product  are receiving what  product changes/ 
quarterly in our Management  changes/ Results are  they expect and when  Results are used as part 
Review process used as part of our  they expect it. of our trending process 
trending process and  and also reviewed in 
also reviewed in  Management Review
Management Review
Capture Frequency Monthly Monthly Weekly Daily
Organization  Quarterly Quarterly Quarterly Quarterly
Reporting Frequency
16