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.”

2. 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

3. 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.

4. 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.”

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