Hello,
I am writing an article on the evolution of CDRH's Expedited Access Pathway (EAP) and Breakthrough Device Programs (BDP) for MD&DI. We are reaching out to companies (and FDA) that have gone through the program to get their perspectives. If you have gone through, or are going through the EAP, I would love to get your perspective. Some of the questions I hope to answer are:
- What kind of device was subject to the EAP, and which branch of CDRH governed this product?
- What was it that made you think that your device was eligible?
- Did the FDA approach you about the program (e.g. pilot program), or did you approach them?
- Have you received approval? If so, how long did it take?
- Do you feel that FDA provided adequate support throughout the process?
- What benefits did your company reap and what challenges did you face throughout the process?
- Would you do it again?
- Are you aware of the new Breakthrough Devices Program and the draft guidance? Have you read it? Are you confident that these changes will improve the process?
I am on a bit of a tight timeline (need to present a draft early next week), so any feedback this week would be greatly appreciated. If you prefer to discuss/answer privately, you can reach me on my cell (650.213.2370) or by email (
kmallet@pai-qbd.com).
Thank you in advance.
Kindest regards,
KAM
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Kerri-Anne Mallet
Vice President, Clinical & Regulatory Affairs
Pharmatech Associates, Inc.
Hayward, CA
Phone: (650) 213-2370
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