ImpediMed Limited, a provider of medical technology used to measure, monitor and manage the status of fluid and the composition of the body, recently reported that the U.S. Food and Drug Administration (FDA) has released new digital health guidance.
"These guidance documents could significantly impact those companies already in, or about to enter, the digital health space," ImpediMed Managing Director and CEO Richard Carreon said.
The new draft guidance issued by the FDA, titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” will give medical device manufacturers the chance to access Real-World Evidence (RWE) that will support applications submitted to the FDA seeking clearance, approval or both. RWE denotes evidence that is gathered based on the performance of a product and the outcomes in a setting outside of clinical trials, which include hospitals, doctors’ offices and patients’ homes.
The FDA has also published a guidance document called “General Wellness: Policy for Low Risk Devices” stating that the FDA has no intentions of investigating general wellness products that are categorized as low risk, which pertains to devices and software that monitor health information. The FDA will continue to regulate devices and apps that make disease-specific claims.
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