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Does a software platform need FDA approval?

I am looking for an expert opinion as to whether or not our platform requires FDA approval. Some background:

I recently took over a software telehealth company. Our web-based "teleophthalmology" platform is specific to the eye care industry. Buyers of this system include hospitals /institutional care providers and eye care professionals (optometrists and ophthalmologist practices). We have different products including an eye care specific EMR and an electronic referral capability to facilitate coordination between health professionals (e.g. referral from optometrist to ophthalmologist. However, there are two products that may have regulatory implications.

Our flagship product is an end-to-end solution for chronic eye disease detection. It is often used to screen patients for diabetic retinopathy, a leading cause of blindness or vision loss among diabetics. As a preventative measure, diabetic patients should get their retina scanned by something called a fundus camera. These devices capture the retinal images and are FDA certified as a medical device. Once the ocular images are taken, they are uploaded to our platform much like the way an MRI or X-Ray is uploaded to a PACS. These images can be in various formats (usually DICOM but also JPG, TIFF...). From there, our platform routes the image with patient clinical info to ophthalmologists who will view them and render an interpretation. Our system provides a built-in viewer with image enhancement tools and provides structured reporting. Our system does not provide any computer assisted or AI-based interpretation capabilities. In addition, the system offers workflow management, patient scheduling and a bunch of other features necessary of a screening program.

We are in launching a new product that will enable an ophthalmologist to conduct an exam from a remote location. Through a device called a digital slit lamp operated by an optometrist or technician at the other end, the ophthalmologist will see a live, HD video.

The company obtained Health Canada's (our version of FDA) Class II certification in 2014 but decided to let it go on the basis of an opinion from a medical devices consultant who said it was not necessary for the type of products we provide. Our software is used in major health centers in Canada and none make Class II mandatory.

However, we are now entering the US market and are looking for a reliable opinion as to whether or not FDA approval is required. If it was required, I'd also like to know what the process is and whether you need a consultant to guide you.


4 Replies

Jennifer Ernst
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Jennifer Ernst Entrepreneur • Advisor
Marketing | Business Development for early-stage, high-growth tech
I'd suggest getting an opinion from a qualified (and trusted) regulatory service. Message me separately if you would like recommendations. Likely answer will be "yes." As an example, we were considering using bluetooth to modify settings on a Class 1 device, and were advised that the software itself would require FDA approval.
Richard Pridham
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Richard Pridham Entrepreneur • Advisor
Investor, President & CEO at Retina Labs
Jennifer: I will message you directly. Thanks.
J Christine Feeley
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J Christine Feeley Entrepreneur
Lead Gen Marketing & Sales Expert
Rich I do a lot of work in this category...based on my experience, your biggest regulatory issue is going to be EHR, and meeting Back-up, Security and Encryption criteria. This will be from both the Healthcare facilities perspective and Reg compliance. I don't think it's an FDA issue....but I agree with Jennifer....better to have expert guidance. You'll get to the right department and guidelines faster.
Giles Crouch
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Giles Crouch Entrepreneur
Digital Behavioural Economist | Speaker | Writer | Technology Strategist | on Twitter @Webconomist
Having brought 2 medical devices into the U.S. and a couple of health care products and testified before an FDA hearing...what Jennifer Ernst says is bang-on. It is not better to ask for forgiveness when it comes to the FDA. If you're device is participating in a diagnosis, you'll likely need FDA approval. And incidentally, Health Canada approval means nothing in the U.S.
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