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Medical Device Discovery Appraisal Program (MDDAP) Application

MDDAP Applicant

Medical Device Discovery Appraisal Program (MDDAP) Application
CONTACT INFORMATION *This question is required.Please provide the following information for your organization's point of contact in this program.
This person should be able to engage with ISACA in discussions regarding your company's Medical Device Discovery Appraisal.
FACILITY/SITE INFORMATION *This question is required.Please enter the following information for the manufacturing facility/site you would like to enroll in the program.
The inspections opportunity will apply to the facility associated with the establishment registration # and the 30-day change notice opportunity will apply to the current device(s) associated with that establishment registration #.
1. ADDITIONAL QUESTIONS *This question is required.Please answer the following questions to the best of your ability.
We collect this information to make a better determination of your organization's eligibility, and flexibility may be offered in discussions with the FDA after enrollment.
Which class(es) of medical device(s) does your company's above facility manufacture?Please check all that apply.
Does your company's above facility currently distribute medical devices in the U.S.?Distribution includes marketing and sales of medical devices.
Does your company's above facility currently manufacture devices that are pending clearance and/or approval in the U.S.?Include any pending products.
Is your company's above facility under Official Action Indicated (OAI) status or subject to a judicial action from FDA?If yes, additional discussions with the FDA will occur prior to being eligible for benefits.
Is your organization registered as a Small Business with FDA?
Please select all Office of Health & Technology categories that apply to your company: *This question is required.Please check all that apply.
Please select the company type(s) that applies to your organization: *This question is required.Please check all that apply.
DISCLAIMER AND SIGNATURE *This question is required.I certify that the answers provided are true and complete to the best of my knowledge.
I understand that false or misleading information in my application may result in ineligibility for the MDDAP benefits.

By signing below I agree to the following program participation requirements:
- Annual Program Fee to be paid once you are accepted into the 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.
Signature of