“A package of new guidance documents from the FDA describes what and how the agency plans to regulate as software designed to aid clinical decision-making—such as programs that provide documentation and diagnostic support or that call up medically relevant reference information and recommendations based on patient’s particular case.”
“The guidances also include updated, finalized policies for the regulation of smartphone-based medical apps, as well as manufacturers’ use of so-called ‘off-the-shelf’ commercial software in medical devices.”
“The FDA defines software for clinical decision support, or CDS, as tech that can provide doctors, patients or caregivers ‘with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.’”
“In its latest draft guidance, the agency said it plans to apply a risk-based strategy for enforcing device-related requirements. It does not intend to regulate certain types of low-risk software—such as programs designed to help inform patients and caregivers in managing non-serious conditions without the help of a doctor—especially when those users can independently check and understand the basis for the programs’ recommendations.”
“Instead, the FDA said it plans to focus oversight on higher-risk software functions, including those used in serious or critical situations—as well as machine learning-based algorithms, where the program’s logic and inputs may not be fully explained to the user…” Read the full article here.
Source: FDA delivers regulatory guidance on AI software and clinical decision-making aids – By Conor Hale, September 26, 2019. FierceBiotech.
