A new guidance from the Medical Device Coordination Group (MDCG) clarifies that software as a medical device (SaMD) product can operate under a limited amount of regulatory oversight when deployed only in a single healthcare entity, which gives smaller developers an opportunity to gain a foothold in the European Union (EU) while they add to their to-market capabilities.
Many expected the FDA pilot program for software precertification to be a potential solution to many of the problems with the agency’s regulation of software as a medical device (SaMD). Unfortunately, it appears the precertification pilot was less than successful in providing a new regulatory path forward.
Most FDA final guidances offer little more than a modest rewrite of the draft, but the FDA’s final guidance for clinical decision support (CDS) software represents a significant revision of the draft version. The changes seen in the final guidance may alter the regulatory status of both existing and developmental products, and developers of CDS software may wish to reevaluate their products in light of this new guidance.
Electronic Quality Management System
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