Category Archives: FDA

FDA

Full Cycle Teams in a FDA regulated setting

Posted on January 4, 2021 by Bob

The 200X hot topic was Agile development in a FDA regulated setting. Over a decade later this should (hopefully) be a settled issue. I can’t imagine anyone still doing water-fall these days. The new challenge for medical device companies is … Continue reading →

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Software Doesn’t Have An MD

Posted on January 25, 2015 by Bob

I got a kick out of this Andreessen Horowitz piece: Digital Health/SOFTWARE DOESN’T HAVE AN MD. I’m sure ‘the kid in the garage without a degree’ is no dummy, but this premise: And so that large percentage of medicine that is effectively … Continue reading →

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FDASIA Health IT Report

Posted on April 5, 2014 by Bob

The Food and Drug Administration Safety and Innovation Act (FDASIA) required the FDA to develop: a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that … Continue reading →

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FDA Regulation of Mobile Medical Apps

Posted on September 23, 2013 by Bob

The FDA has issued their final guidance on mobile medical applications: Keeping Up with Progress in Mobile Medical Apps. The guidance document (PDF) will “give mobile app creators a clear and predictable roadmap to help them determine whether or not their … Continue reading →

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FDA Recognition of Medical Device Standards for Interoperability

Posted on August 11, 2013 by Bob

This is a follow-up to Interoperability: Arrested Progress. The FDA has recognized voluntary interoperability standards for medical devices: Improving Patient Care by Making Sure Devices Work Well Together. The FDA and HHS has (my highlight): published a list of recognized standards for interoperability … Continue reading →

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Interoperability: Arrested Progress

Posted on July 28, 2013 by Bob

When it comes to the state of interoperability in the medical device industry there couldn’t be a better metaphor than Arrested Development*.  A dysfunctional family made up of eccentric well-meaning personalities each doing their own thing, oblivious to each other and the rest … Continue reading →

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Medical Device Innovation Consortium

Posted on December 5, 2012 by Bob

The FDA has announced the Medical Device Innovation Consortium (MDIC)  which aims to help medical device companies get their products to market faster. See FDA, Private Groups Team Up to Speed Device Approval. The term Regulatory Science is used 12 times on the single … Continue reading →

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When Open-source can Kill or Cure

Posted on June 6, 2012 by Bob

The use of open-source software in medical devices has been a topic of discussion for many years. The Economist article Open-source medical devices: When code can kill or cure highlights continuing activity in the academic community and interest by the FDA in developing … Continue reading →

Posted in FDA, Medical Devices, Open Source | 4 Comments

OTS/SOUP Software Validation Strategies

Posted on February 16, 2012 by Bob

My last discussion of Off-The-Shelf software validation only considered the high-level regulatory requirements.  What I want to do now is dig deeper into the strategies for answering question #5: How do you know it works? This is the tough one. … Continue reading →

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Building Safety into Medical Device Software

Posted on January 7, 2012 by Bob

The article Build and Validate Safety in Medical Device Software takes a critical look at the current processes for medical device software and concludes: The complexity of the software employed in many medical devices has rendered inadequate traditional methods (testing) for demonstrating … Continue reading →

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