FDA Releases Guidelines on Regulation of Medical Software

The Food and Drug Administration (FDA) has updated its guidance on which medical devices will now be regulated by the agency. As reported by Modern Healthcare, the FDA will focus on overseeing “clinical-decision support software meant to help providers and patients manage ‘serious or critical conditions.'” According to the FDA notice, it will no longer monitor general health and wellness apps, electronic health record systems or administrative software systems. Principal Deputy Commissioner Amy Abernathy says that, while these types of technologies can “provide great value to consumers and the healthcare system,” they “pose a low risk to patients.”

The update is in response to the recent surge of medical technology and, as outlined by Health Data Management, provides necessary “clarity on the scope of the FDA’s regulation of software intended for healthcare professionals and patients.” Health Data Management also notes that this clarification includes the specific kinds of software that are no longer legally considered medical devices.

Click here to read the official guidance issued by the FDA.

MLMIC recommends that all our insured physicians, other healthcare providers and facilities be vigilant in the use of clinical-decision support software.  As technology continues to expand throughout healthcare, careful consideration must be exercised in choosing, using and updating technology that impacts the practice of medicine and patient care. 

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