Modern Healthcare September 27, 2019
The Food and Drug Administration released new guidelines clarifying which types of medical software systems do—and do not—fall under the agency’s regulatory oversight.
Under a set of companion guidelines released Thursday, the FDA outlined a plan to focus its regulatory oversight on clinical-decision support software meant to help providers and patients manage “serious or critical conditions,” said Dr. Amy Abernethy, the FDA’s principal deputy commissioner.
Software designated as being low risk, such as smartphone apps that encourage general wellness or healthy lifestyles, will be excluded from agency oversight.
“Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system,” she said in a statement.
...Today's Sponsors
Today's Sponsor