What is expected from companies participating and NOT participating?
Companies may request to enroll into the program through an online application process.
Minimum enrollment requirements:
- 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.
Expectations of Particpants:
- Annual subscription fee of $5,000 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.
*Companies not participating will not see any changes in their engagement.
What will be shared and with whom?
How appraisal data is shared depends on who is the recipient of the information.
The organization being appraised will receive a set of findings reflecting strengths, weaknesses and notes to consider against the CMMI model’s specific and generic practices. These findings are typically shared in a presentation with all the members of the organization that participated in appraisal activities. The organization’s appraisal sponsor (this is a named member that internal to the appraised organization) will be delivered a documented set of these findings. These will include a process capability assessment providing a numeric representation of how the organization performed against the framework at the practice level. These are also aggregated at the process area level and then are considered in an overall average.
The appraisal team will also deliver these findings and the scorecard to the CMMI PMO. The PMO will hold the specific data in the confidence but will share the appraised organization’s process area aggregate scores and the overall cumulative score with the FDA. The CMMI PMO will also perform analysis of these data over multiple appraisals for trend analysis. No organization’s specific appraisal data will be shared by the CMMI PMO or the FDA with any other organization. Trends provided by the CMMI PMO to the FDA and the broader MDIC participants will be only provided in a manner that assures participating organizations cannot be identified.
What are the risks of participating?
- Legal/Legislative Risks
- What happens when something goes wrong (questions from congress)
- Exposure of quality data (not releasable for FDA)
- Participant Risks
- Exposing too much information
- Greater public scrutiny; certifications need to be public
- Raising barrier to entry
- No alignment with districts
- Watch dog group will watch this
- CMMI barrier to entry
- Economic risk and driving consumer market
- Data Integrity Risks
- Data management/security/hacking
- Access to data
What is the difference between small and large companies cost/benefits?
There are no differences in benefits provided between large and small organizations. Costs of an appraisal are determined as part of the scoping of that activity and consider a variety of factors including (but not limited to) the number of practice areas as the criteria, the number of products reviewed, and quality system complexities.
How is CMMI and 820 compatible?
There are no incompatibilities between quality system regulations and the CMMI framework. The CMMI framework provides an approach that allows organizations to further improve the quality in their products and services.
Will there be a public dashboard? Can I see comparative data?
Aggregate data will be shared among the participants during the pilot program on a regular basis once a representative sample size is achieved. This shared information will be deidentified but will allow comparative review across the participants.
How is CMMI institute providing oversight methodology and appraisers?
The CMMI Institute has a historically proven model, specific qualifications and certifications for lead appraisers, and a clearly documented methodology for executing appraisals. In addition, for this Medical Device Discovery Appraisal Program, specific additional expectations and training have been defined collaboratively by the CMMI Institute, the FDA, MDIC and industry partners. Appraiser and appraisal team performance are regularly monitored by the CMMI Institute Project Management Office (PMO).