FDA posts updates for SaMD pre-certification program

The U.S. FDA provided an update for the pre-certification program for software as a medical device (SaMD), stating that the agency’s testing of the excellence appraisal element demonstrated the ability to confirm an organization’s capabilities. Conversely, the agency said it had seen some variability in the information needed from the streamlined review process to achieve a review process that is comparable to conventional premarket reviews. Future work on the pre-cert program will be directed toward a standardization of the streamlined review process to resolve these discrepancies. The agency said it is also examining ways in which sponsors and developers can define their software products consistently while leveraging international standards for SaMD clinical evaluation to ensure a consistent approach. Another point of interest for the FDA is to develop a series of methods for routinely collecting real-world performance data for both sponsors/developers and specific products that would sustain the organizational excellence appraisal process throughout the product life cycle. There is also an emphasis on development of a framework and associated mechanisms for collecting real-world performance data in lieu of manual data collection. One possible mechanism is automated remote access to a digital device, while the library for key performance indicators will be further developed.

FDA wraps up standards guidance

The FDA posted the final guidance for recognition and withdrawal of voluntary consensus standards, highlighting the characteristics of organizations that develop such standards, which includes openness of parties that can offer input into standards development. The agency will emphasize U.S. and international standards, but will consider other national standards for matters for which no U.S. or international standard is available. Normative standards, also known as clauses within standards, will not generally be considered for adoption, although the FDA will make exceptions “in limited circumstances.” The agency also said it will hold an Oct. 15 webinar to provide more detail.

Two recalls for BD Alaris infusion pumps

The Carefusion subsidiary of Becton, Dickinson & Co. (BD), of Franklin Lakes, N.J. has recalled again the Alaris series of infusion pumps due to several hardware problems, including damaged inter-unit interface connectors that lead to interruption of infusion therapy. Other problems leading to a class I recall designation are improperly secured computer unit batteries (loss of power) and broken hinge posts on the pump platen. The pumps may also have dim displays, triggering a class II recall. In a separate recall, BD said a class I recall has been undertaken to deal with PC unit keys that may become stuck.

MITA urges action on disinfection guidelines

The Medical Imaging & Technology Alliance (MITA) advised the FDA that its member companies are concerned about the use of inappropriate cleaning agents and disinfectants on medical imaging systems, a practice MITA said could damage these systems and lead to system down time. The letter offers the example of a high-level disinfectant that damaged an ultrasound probe’s lens, requiring replacement of that part. MITA executive director Patrick Hope said the association’s members “certainly do not want medical imaging devices to be vectors for transmission of COVID-19,” but that cleaning products are being offered for sale without the appropriate validation. The letter asked the FDA to communicate to the public the importance of following OEM cleaning guidelines.

No Comments