Medical Device Discovery Appraisal Program (MDDAP) FAQ

CDRH Voluntary Medical Device Manufacturing and Product Quality Pilot Program

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What is the Case for Quality (CfQ)?

 

What is the CDRH Voluntary Medical Device Manufacturing and Product Quality Pilot?

 

Why did CDRH choose CMMI for this activity?

 

What is CMMI?

 

Who is the CMMI Institute?

 

Are there any examples of medical device manufacturers who have publicized their participation in the CMMI program?

 

Why should my company participate? What are the tangible benefits from CDRH? When do I recognize them?

 

How do I share this program and its value with senior management in their language?

 

What is expected from companies participating and NOT participating?

 

What is the difference between small and large companies’ costs and benefits?

 

What benefits do I get with enrollment?

 

What are the requirements to enroll?

 

Do I enroll my organization or a facility?

 

Should I enroll multiple sites? How?

 

How much does it cost to enroll?

 

What information do I need to enroll?

 

Who should I list on the enrollment form?

 

How long do I need to wait for approval into the program by the FDA?

 

How will I know if I have been approved into the program?

 

What if I am not approved into the program?

 

What happens after I am enrolled?

 

What is the purpose of an initial scoping call?

 

How long is the initial scoping call?

 

Who schedules the initial scoping call?

 

Who needs to be on that initial scoping call?

 

What should I do to prepare for the initial scoping call?

 

What sort of questions are asked in the scoping calls?

 

What if we don’t get a chance to cover everything in the first scoping call?

 

When do we need to have the initial scoping call?

 

What do I need to do to complete this baseline performance metrics collection form?

 

What is the baseline performance metrics for used for?

 

What is the longest period of time that I can wait from enrollment to the appraisal occurring?

 

Does a site have to be appraised to get the regulatory modifications?

 

How is this different than an FDA inspection?

 

What if I want more information about the CMMI model?

 

Can I extend the scope of my appraisal to include other CMMI practice areas?

 

What does an appraisal cost?

 

What scores do I need to get to “pass” the appraisal?

 

What does the site need to do to prepare for the appraisal? What people from the site are expected to participate in the appraisal?

 

Who are the people performing the appraisal? Can I pick who they are?

 

How is CMMI institute providing oversight to appraisal methodology and appraisers?

 

How many appraisers participate in the appraisal?

 

Can I provide my own appraisers?

 

Approximately how long would an appraisal be?

 

Do you have an approximate schedule or agenda for an appraisal?

 

Can I get a copy of the questions that will be asked in the appraisal?

 

What is the heat map tool?

 

Where do my appraisal results and performance metrics go? Who has access to them and to what level of detail?

 

What will be shared and with whom?

 

Will there be a public dashboard? Can I see comparative data?

 

Do I get to see other participants’ appraisal results?

 

Am I obligated to correct or improve my organization’s appraisal results?

 

Can I work with my lead appraiser further to determine if we are addressing our findings appropriately?

 

How frequently do I need to do a regular appraisal?

 

What if I want to pursue a maturity rating?

 

What happens if I disagree with a finding?

 

What happens if I want to express concerns about my appraiser or the appraisal team?

 

What regulatory modifications do I receive after the appraisal? When does this happen, how do I know? How long are these good for?

 

What is the check point process?

 

How is CMMI and 820 compatible?

 

Will I need to engage with the FDA?

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