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US FDA’s Pre-Cert Pilot for Medical Device Software Moving into Testing Phase


  • US FDA has issued a new regulatory framework, working model and test plan for its Pre-Cert pilot program for Software as a Medical Device (SaMD).
  • The FDA Pre-Cert regulatory pathway would utilize FDA’s De Novo classification request framework for qualifying SaMD products.
  • FDA is accepting comments on these Pre-Cert updates through March 8, 2019.

Sharfstein Out at FDA

The FDA’s second-in-command Joshua Sharfstein is stepping down as principal deputy commissioner to become Maryland’s secretary of health and mental hygiene, according to

FDA Proposes Recordkeeping Requirements for Third-party 510(k) Reviewers

The US Food and Drug Administration (FDA) has proposed (Docket No. FDA–2010–N–0447) new rules targeting how third-party premarket notification (510(k)) reviewers appointed by the agency maintain relevant documents and records. Specifically, the FDA has submitted rules regarding the Third Party Review Program established under the Food and Drug Administration Modernization Act of 1997.

FDA Hosts Public Hearing to Address the Internet and Social Media and how they Relate to Product Regulation

The FDA is holding a public hearing on November 12 and 13, 2009 from 8am to 5pm each day to discuss the increasing challenges that social media and the internet have presented to product regulation. The hearing will be at the National Transportation Safety Board Conference Center in Washington, D.C. In addition to the public meeting, the FDA will also accept comments (electronic and hard copy) until February 28, 2010. 

US FDA may get large increase in funding

Today the Wall Street Journal published an article noting that President Obama has requested an additional $300,000,000 in funding for the US FDA, from $2.06 billion to $2.35 billion. That's a 14% increase.  If the funding is approved by Congress, the agency will likely hire more inspectors which will lead to more frequent visits from the FDA to medical device manufacturers.

US FDA announces new website

The Food and Drug Administration has said that it plans to launch a redesigned website, presumably in 2009. This should be good news for users of the site. Hopefully, guidance documents and other relevant information will be easier to find, and databases will be easier to use.  Keep your fingers crossed.