EAN SuppliersEAN SubscribersRMSPRI Training Learn Center

Menu

Voluntary Improvement Program | VIP

Supported by the FDA, the Voluntary Improvement Program (VIP) can enhance a medical device maker’s products and performance. 

Design, Build, and Deliver Safer Medical Devices – Faster!

Get a VIP Quote Today

What is the Voluntary Improvement Program?

REDUCTION IN COMPLAINTS
95%
ADDED TO ANNUAL SALES
$15 MILLION
NCR AND CAPA REPORTS FASTER BY
87%
INCREASE IN DAILY PRODUCTION OF
65%
DECREASE IN STAFF TURNOVER
70%

VIP Benefits

As outlined by the FDA Final Guidance, participants may benefit from several opportunities to help accelerate improvements to device quality and manufacturing, including:

INSPECTIONS

A risk-based approach to FDA inspection planning and resource allocation for routine surveillance, pre-approval and post-market inspections.

30-Day Change Notices

Enables use of a modified submission format with reduced timeframes (resource permitting) for Premarket Approval Application (PMA) and Humanitarian Device

SITE CHANGES

Enables use of a modified submission format with reduced timeframes (resource permitting) for PMA and HDE Manufacturing Site Change Supplements

MANUFACTURING MODELS

Program data enables use of a modified submission format for PMA or HDE Manufacturing Modules.

Participant reported benefits from the regulatory opportunities:

  • Savings of 1000+ personnel hours and 90% of dedicated resources
  • 75-90% faster review and approval of submissions
  • Improved product quality, availability & cost
  • Accelerated time to market
  • Tens of thousands of dollars saved

 

Get involved with the Voluntary Improvement Program

Content
  1. Part of lifecycle for medical devices distributed in the US (Class I, II, III)
  • This can be any facility which “designs, manufactures, fabricates, assembles, or processes a finished device.”
  • Can include, but is not limited to, “those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.”
  1. Companies should have all of the following:
  • Prior compliance history or compliance profile (i.e. US FDA inspection or MDSAP audit)
  • Site registration with US FDA
  • Device listing with US FDA
  1. Facilities must not be under Official Action Indicated (OAI) status or subject to a judicial action. Voluntary Action Indicated (VAI) is acceptable.
  • Companies with OAI can become eligible when they have provided the FDA with confirmation that appropriate corrective action has been implemented, and those actions have been verified by the FDA during a follow up inspection.
  1. Companies may want to seek additional eligibility information if they are a new manufacturer, start-up company, without a compliance profile, or not marketing products in the U.S.

For further guidance view the FDA guidance document “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.”

FDA guidance document
Content

An experienced appraisal team will evaluate your organization’s capabilities through conversations with individual contributors, systems demonstrations, site tours, etc. This evidence is then evaluated against a proven set of best practices, the CMMI model, and the results allow the organization to easily identify areas of strength and opportunities for improvement. You’ll be empowered to prioritize opportunities that align with your business objectives, while quarterly check points provide progress tracking and guidance on improvement projects.

Apply Now
Content

As a VIP participant, you can take advantage of networking and learning opportunities to shape the future of the program. Our Working Groups, mentorship, monthly participant calls and more create a vibrant community to assist in your overall progress.

Qualify