Why was the program created?
FDA launched the Case for Quality in 2011 to elevate the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes. A cultural shift of this magnitude demands the engagement of regulators, industry, providers, payers and patients. So in 2014, FDA enlisted the Medical Device Innovation Consortium (MDIC) to foster a new level of collaboration between the Agency and industry in a far-reaching Case for Quality movement.
Why is CMMI involved?
In a 2015 study, MDIC researched 22 different maturity models and recommended the CMMI framework for a variety of reasons ranging from its global recognition across multiple industries, to its decades of demonstrated success, to its flexibility across companies of various size, organizational and geographic structure, and product portfolio. Leveraging the Capability Maturity Model, a product of the CMMI Institute, medical device organizations enrolled in this program will be periodically appraised to determine their process capabilities and how they are continually improving the quality of their processes, systems and products. Participating organizations are eligible for regulatory modifcations from the FDA.
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.
If you have any questions or need assistance, please contact us at firstname.lastname@example.org.