• 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 Approves First DTC Tests Evaluating Genetic Risk Information

    The US Food and Drug Administration (FDA) on Thursday authorized the first direct-to-consumer (DTC) genetic health risk tests for 10 diseases and conditions. The authorization for the genetic testing company 23andMe means individuals for the first time will be able to use these tests to understand their genetic predispositions for certain diseases and conditions without first seeing a doctor. “Consumers can now have direct access to certain genetic risk information,”...
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    Regulating Precision Medicine: Capacity vs. Overreach

    As the boundaries between the clinic, the research lab and industry continue to shift, researchers are calling on the US Food and Drug Administration and other similar regulators worldwide to tread carefully in how they effectively facilitate the practice of precision medicine. In an article published online this week in the Journal of Law and the Biosciences , titled “Precision medicine: drowning in a regulatory soup?” a group of mostly Australian researchers note that...
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    FDA Proposes to Exempt Some Genetic Screening Systems from Premarket Requirements

    The US Food and Drug Administration (FDA) has decided to look into exempting from premarket requirements some genetic screening systems that can test parents for specific conditions they could possibly pass down to their children. The possible exemption of the autosomal recessive carrier screening gene mutation detection systems, which are Class II devices, would help companies bring to market systems that can test parents for specific genetic conditions, such as cy...
  • Senator Calls out Federal Health Officials Over Contradictory FDA, CMS Policies on Health Information

    Late last year, the US Food and Drug Administration (FDA) made headlines by sending a Warning Letter to direct-to-consumer (DTC) genomics testing company 23andMe alleging that its flagship testing product was misbranded. Specifically, regulators said 23andMe's Saliva Collection Kit and Personal Genome Service (PGS) was acting as a medical device in that it was informing people of their risk of developing various diseases and conditions, in effect acting as a diagnosti...