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  • Regulatory NewsRegulatory News

    FDA Announces Streamlined Review Pathway for DTC Genetic Tests

    The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the market. To do so, FDA is proposing a model similar to a pilot for digital health products, by which companies can be pre-certified to market low-risk software-based devices following an assessment of their systems for software design, validation and maintenance. Similarly, F...
  • Regulatory NewsRegulatory News

    FDA Exempts 120 Medical Device Types from Most Regulation

    The US Food and Drug Administration (FDA) plans to exempt 120 medical device classes from its premarket notification and review requirements, making it substantially easier for companies to market the devices. Background Under existing regulations, FDA regulates devices according to three general categories: Class III – High-risk devices; require the submission of a Premarket Application (PMA). Class II – Moderate-risk devices; require the submission of a Premarket N...
  • Regulatory NewsRegulatory News

    Medical Device Data Systems to be Exempt from Regulation, FDA Says

    In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices like weight scales and glucose meters—from regulation, abandoning an earlier plan to regulate them as Class I ("low-risk") medical devices. The announcement comes more than three years after FDA down-classified MDDS devices from Class III ("high-risk") to Class I. Whil...