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...Read More
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...Read More
Medical devices are now considered a subtype of Internet of Things (IoT) devices [(2) https://owasp.org/www-pdf-archive/SecureMedicalDeviceDeployment.pdf]. There is a growing need to properly document the physical off-the-shelf (OTS) subsystem components that a medical device contains. Medical devices are often no longer stand-alone devices which contain only proprietary components. Inattention to additional components may lead to a...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.