Hardware · FDA Regulation

How do I get FDA Approval for an at-home Hardware Device?

Robert Bent Founder - INVI Energy

December 28th, 2014

I am looking for a consultant to help me navigate the FDA approval process.  I am converting a clinical device into hardware for use at-home directly by the end user.  I would like somebody to help describe procedure and estimate timeline and cost.  What is the best way to find this person?

Michael Barnathan

December 28th, 2014

Have you figured out what medical device class your device falls into? (1, 2, or 3). That's the first step. If your device is a class 1 or 2 device, are you planning on going through the full approval process, or 510(k) premarket notification? It sounds like your existing clinical device might be a good predicate if you choose to go that route, and it will get you on the market much faster. I should warn you that going through either process will be expensive and time-consuming.

Michael Barnathan

December 28th, 2014

See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ for the various device classifications and the procedures required to get the device on the market.

Bob Binder Member of Technical Staff at Software Engineering Institute | Carnegie Mellon University

December 28th, 2014

Suggest you contact EdgeOne Medical.  They're a startup focused on exactly this problem

http://edgeonemedical.com/

Contact Jim McGough, Co-Founder.

 

Adam Craft Principal Designer

December 28th, 2014

My partner and I have experience guiding several products through the 510K FDA process. Feel free to PM me with what type of product you are developing and I will try to assist further.  

Trevor Collins Crowdfunding Entrepreneur & Co-Founder of 100 Danish

December 28th, 2014

Hi Robert,

My girlfriend Emily does this for a living and would be happy to connect with you for a quick 10min. You can talk to her for a bit of advice on how to file yourself or you can hand it over to her company and they'll file it for you. PM me. 

Anonymous

December 28th, 2014

Hi Robert, I am a Regulatory Affairs consultant with 20+ years working with the FDA in pharmaceuticals and medical devices. I would be happy to talk with you to discuss the process, timelines, studies/data required, etc. Please PM me

Robert Bouthillier Owner, Design Net

December 30th, 2014

Robert, it seems like you have found some great resources to help navigate the best approach for 510k/FDA clearance.    If you need any help with creating the product for home use, we have done a number of products for the home, many of which leverage connectivity via mobile devices through apps for iOS and Android.   If your device will be mobile-linked, we recommend submitting your app to Apple before finalizing your Instructions for Use (IFU) for submission to the FDA - as Apple has some strict rules about usability that often result in changes to the UI and to the IFU.