Managing Digital Health Regulatory Uncertainty
Uncertainty abounds when managing digital health regulatory uncertainty regarding the FDA and...
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Category: Regulatory Bibliography
FDA Busy With Software
Since connectivity runs on software, and some medically related software is a medical device, and...
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FDA Guidance on Software Changes
On October 25, 2017 the FDA released its guidance on "Deciding When to Submit a 510(k) for a...
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Sussing Out SaMD — Software as a Medical Device
Software as a Medical Device (SaMD) is terminology under the aegis of a work group of...
Read MoreCharting Your Regulatory Course
Do you think your product could be a regulated medical device? There are all kinds of regulatory...
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Impact of Modifying FDA Regulated Devices
Unfortunately for you, congress did not wish to extend the physician exemption to hospitals.
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Facing FDA Regulations for the First Time
What are your risks in being part of a regulated device, and what can you do to make yourself a more attractive supplier?
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