The U.S. Food and Drug Administration (FDA) announced today that AAMI SW96 Receives FDA Consensus Standard status.  Medical device manufacturers are now expected to conform to the requirements of this standard as applicable, or have processes that show address the requirements of the standard. The broad outline of AAMI SW96 is: General requirements for security...Read More

On June 7th, 2021, the FDA updated their database of recognized consensus standards. This update included two new items related to medical device software. These two items are IEEE standards that are relevant to all medical devices that claim interoperability with other networked entities. They are being recognized based on their scientific and technical merit...Read More

On Jan 14, 2019, FDA recognized ANSI AAMI SW91:2018 Classification of defects in health software.  The FDA recognition statement for this standard does not indicate any specific use in premarket submissions or relevant FDA guidances. It simply states it supports existing policies.  This standard is lengthy and technical in terms of its approach to defect...Read More

FDA released a draft guidance document, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” on January 7, 2025. The document provides recommendations on the contents of submissions (be it a 510(k), De Novo, PMA, HDE, or BLA) to FDA for devices that include AI-enabled device software functions and provides recommendations for the...Read More

SoftwareCPR’s partner Dr. Peter Rech convened the IEC TC62/SC62D/MT23 Infusion Pumps working group meeting held from April 22nd to 26th at the AAMI headquarters in Arlington, VA. The attendants included international experts and guests joining from governmental agencies, infusion pump manufacturers, test houses, and clinical research institutions. Progress was made on a variety topics: Pump...Read More

We are pleased to announce our SoftwareCPR® Partner, Dr. Peter Rech, will lead the international working group meeting of IEC TC62/SC62D/MT23 Infusion Pumps as its Convenor. The meeting will be hosted by AAMI at the AAMI headquarters from April 22nd to 25th, 2024, in Arlington, VA. The meeting will be dedicated to the maintenance of...Read More

Probabilistic Genotyping Used for Criminal Prosecution In a recent article published on The Markup, software that is used to match DNA in criminal prosecution has come under scrutiny.  The software implements what is known as probabilistic genotyping, a method used when analyzing data that contains a mixture of DNA from multiple people.  The software uses complex...Read More

This July 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, our report keeps you...Read More

This September 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...Read More

This July 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...Read More

This February 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...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

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

This 62304 Conformance Checklist Tool is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 62304 can provide an excellent framework from which to design a software process for medical device, medical mobile app, and/or HealthIT software.  62304 was created specifically for this type of software - it was not...Read More

The US FDA Center for Biologics Evaluation and Research (CBER) finalized the December 2017 draft guidance titled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” today.  The guidance makes clear that CBER recognizes the value and proper usage of standards and further encourages the...Read More

This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Recent standards and regulatory activity overview Medical device software Following the failure of the DIS of 62304 to be approved, the IEC 62304 working group requested input from the ISO and IEC member countries. There was not a consensus...Read More

This final guidance, “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” replaces the 2013 draft guidance. This guidance focuses on clarifying and formalizing existing FDA practice including the requirement to submit FDA’s standards form for each standard used as well as discusses the use of obsolete standards. Originally standards were a...Read More

FDA has posted their FY 2019 Proposed Guidance Development list with priorities. A link is provided below but here is the “A” list items: Final Guidance Topics Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions Unique Device Identification: Policy Regarding Compliance Dates for Class...Read More

On Dec. 8, 2017, the FDA released the final guidance, “Software as a Medical Device (SAMD): Clinical Evaluation.” The October 14, 2016, draft is now obsolete. This guidance is actually the use of an International Medical Device Regulators Forum (IMDRF) document completed in June of 2017, so this represents broad international consensus. This guidance discusses...Read More

The FDA issued the final guidance entitled “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” This guidance addresses medical devices that exchange information; whether wired or wireless, or through the internet. It includes unidirectional exchange, bidirectional, or command and control. The guidance focuses on data exchange not physical connection types. It includes a...Read More

For devices where the medical device manufacturer intends to maintain remote access capability for service and updates, controls are needed to ensure this access does not compromise the security or operation of the device. There is one FDA recognized standard that addresses this for clinical laboratory devices, but many of the provisions could be instructive...Read More

http://www.fda.gov/cdrh/osel/guidance/321.pdfRead More

http://www.fda.gov/cdrh/ost/guidance/321.pdfRead More

/Docs/ISBT128Nov99.pdfRead More