FDA’s Digital Health “Ask A Question” Portal

Do you have a question about FDA Digital Health Regulatory Policy?  FDA’s Center for Devices and Radiological Health has a resource to help.

I know from personal experience that the Digital Health Team (DHT) at FDA focuses a lot of energy and effort on answering these questions in an effective and efficient manner.

During my time as a member of the DHT and the owner of this FDA inbox, each inquiry would be analyzed and a draft response created.  Each draft was then discussed during a team meeting that was held every week. I would then finalize the response and send it back to the inquirer.

My experience is that the “quality of the question” will have a large impact on the quality of the answer that you get back. You get better answers when you ask better questions.

So if you are considering asking a question regarding FDA’s Digital Health Regulatory Policy, SoftwareCPR can help you craft a better question and achieve what we believe will get better results.  Let us know if we can help.  You can contact us using the form at the end of this post.

Where to send your question?  To this email address digitalhealth@fda.hhs.gov

You can learn more about this FDA service at this link:
https://www.fda.gov/medical-devices/digital-health/ask-question-about-digital-health-regulatory-policies?utm_campaign=2019-11-06%20CDRH%20New&utm_medium=email&utm_source=Eloqua

Recent related post: FDA Releases Digital Health Guidances

About the author

John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.