What are the regulatory modifications?
- Upon approval into the program, your facility will be:
- removed from the FDA's routine inspection list
- Upon completion of a Discovery Appraisal, your manufactured medical devices will be elible for:
- streamlined PMA submission & waived pre-approval inspection
- streamlined site change submission with accelerated approval
- streamlined 30-Day Change Notices, bundling multiple products and changes, with accelerated aproval
- Must be a U.S. based company/site or global company that distributes medical devices in the U.S. (Class I, II, III).
- Facilities must be those responsible for the manufacture and processing of medical devices.
- Facilities must not be under Official Action Indicated (OAI) status or subject to a judicial action.
- Companies with OAI can become eligible for benefits when:
- they have provided FDA with confirmation that appropriate corrective action has been implemented, and
- those actions have been verified by FDA during a follow-up inspection.
- Companies must have  prior history or compliance profile,  site registration, and  listing with FDA.
- Examples of ineligibility include: new manufacturers, start-up companies, no FDA inspections, no marketed products in the U.S., etc.
- Annual subscription fee to be paid once you are accepted into the pilot program.
- Participation in a Medical Device Discovery Appraisal within the 90-day target and payment of the associated costs.
- Submission of metrics at defined frequencies to confirm progress and improvement from initial appraisal results.
- Sustained favorable compliance profile/history as defined in the enrollment requirements.
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