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Timely, insightful, and relevant thoughts, opinions, and discussion on FDA software validation, 62304 compliance, medical device software standards, updates impacting medical device and HealthIT software development, and sundry subjects from our Partners and staff.

This January 2021 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you...
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This December 2020 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards...
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Is it possible to view draft revisions of FDA guidance documents when they are a “work in progress,” or are they only become available once published as draft?  This is a frequent question that I have heard. However, the FDA does not typically provide copies or drafts of “works in progress” for those items that...
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This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. ISO 14971 was updated and released in 2019.  We previously discussed the internal debate regarding ISO 14917 in this post ISO 14971 versus the EU Commission. There are several items to consider with the new update: Section 10.1 - “The manufacturer...
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Compliance and Agile In a prior blog, we discussed a common hurdle to achieving agile benefits: focusing on isolated software process changes and not considering all four organizational factors. Another common hurdle to agile success is thinking only about making agile “compliant.” You will miss the full power of agile if you do not consider...
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance on EMC entitled ‘‘Electromagnetic Compatibility (EMC) of Medical Devices.’’ This new “draft” guidance document is intended to recommend information that should be provided in a premarket submissions to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices and medical...
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At SoftwareCPR today, we honor our consultants that are also veterans who served in our US military! John Murray – US Navy Mike Russell – US Air Force Greg Sandoe – US Marine Corps Jordan Pate – US Army Paul Felten – US Army Thank you for your service!
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Why is a SR or NSR Designation important? The FDA guidance document, “Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies,” sheds some light on the Investigational Device Exemptions (IDE) regulations of 21 CFR 812. The IDE regulations describe significant risk (SR), nonsignificant risk (NSR), and exempt...
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FDA released their CDRH Proposed Guidance Updates that includes a significant amount of “software related” guidance in FY 2021. There are four separate guidance documents listed for publication in FY 2021. IMO that is a fairly large commitment from the agency and I will look forward to reading about the agency’s “current thinking” on these...
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Understanding OTS and SOUP is very important in every lifecycle stages of medical device and HealthIT software development.  In the late 1990’s, the US FDA first published guidance documentation on the use of Off-The-Shelf (OTS) software in medical devices (or sometimes referred to as “OTSS”).  At that time, OTSS generally accounted for a very small...
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