FDA Takes Step Backwards with New MDDS Guidance
This summer, FDA proposed lifting regulations from certain currently regulated medical devices....
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Search Results for: mdds
HIT Vendor Seeking MDDS for Meaningful Relationship
As noted before, from time to time I answer questions and exchange ideas with folks from...
Read MoreIs My Product a MDDS?
I've been getting a lot of questions about this. Here's the latest: I am hoping you can answer this question for me. Â Would [redacted company name] a data storage company come under the MDDS final Ruling? Â Are hw/sw services all...
Read MoreFinal MDDS Rule Signals FDA Shift to Enforcement
The real news behind the final rule is FDA’s stated intent to exercise “enforcement discretion.”
Read MoreFinal MDDS Rule Expected Soon
One should not mistake past regulatory discretion for lackadaisical enformcement on the part of the FDA.
Read MoreWhat’s Wrong with the Proposed FDA MDDS Rule
It is foreseeable… that an MDDS could initiate a command to a medical device that results in unintended operation of the device.
Read MoreFDA Issues New Draft MDDS Rule
Besides the obvious question of whether the FDA is really serious about regulating MDDS, a few things jump out as areas that need clarification.
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Capsule Tech Acquires Bernoulli Health: Analysis
On April 30, 2019, Capsule Tech announced that it is acquiring Bernoulli Health for an undisclosed...
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Hill-Rom Acquires Voalte: Analysis
Hill-Rom announced March 12, 2019 that it was in the process of acquiring Voalte for $180 million....
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