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This "FDA GPSV Traceability Expectations" post is only available to Premium subscribers. See our Subscribe page for information on subscriptions. Going way back to the late 1990's, FDA had an expectation that safe and effective software would require a well thought out development lifecycle that includes many activities designed to ensure the correctness and robustness...Read More

This 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 Navigator keeps you up to date...Read More

ISO 14971 Risk Analysis Identifying safety risks in medical devices is a challenging and laborious process.  The process standard, ISO 14971, is a systematic, total product risk management lifecycle process to identify, control, and evaluate risk, where risk is defined as the combination of severity of the harm (to people, property, or environment) and probability...Read More

I am looking forward to teaching the IEC 62304 Course February 2020 with Brian Pate in Sunnyvale CA. https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 For 15 years I taught the AAMI Software Validation Course with Alan Kusinitz.  These days I have shifted gears to teach the SoftwareCPR 62304 course with Brian Pate. There is a major shift in my perspective between...Read More

Thus far, regulatory guidance for medical device cybersecurity has been focused on the approval or compliance of the device itself and has not been very specific about what cybersecurity assurance information is provided to the health care customers that host the devices within their IT infrastructure.  Medical device labeling has been sparse related to cybersecurity...Read More

Do you have a question about FDA Digital Health Regulatory Policy?  FDA’s Center for Devices and Radiological Health has a resource to help. I know from personal experience that the Digital Health Team (DHT) at FDA focuses a lot of energy and effort on answering these questions in an effective and efficient manner. During my...Read More

The FDA and the NIH National Center for Advancing Translational Sciences (NCATS)/Office of Rare Diseases Research (ORDR) conducted this needs assessment to better understand unmet medical device needs for rare diseases – ultimately to raise public awareness of these unmet needs.  Let this motivate us all to explore, push limits, innovate, and invent.  Onward software...Read More

This 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 up to date on...Read More

For anyone involved in software development, the importance of software requirements cannot be minimized. Software requirements provide the definition and explanation of “what the software should do” and “how the software should behave.” The software engineers and developers use the requirements as input to the software design and coding process. The test developers also use...Read More

Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Premarket Reports (PMRs), notices, and supplements all have associated fees to be paid to the FDA before they will review a medical device product. The 2019 Medical Device User Fee Amendments (MDUFA) are listed at 2019 MDUFA. If the FDA determines that a manufacturer is a “small business”...Read More