FDASIA Workgroup Recommendations

The FDA Safety and Innovation Act (FDASIA) workgroup completed its work and made its draft recommendations in September. The recommendations include: HIT should not be regulated except in cases where there is risk to the patient, a patient-safety risk framework should be used to allow application of regulatory oversight by risk, vendors should be required to list products which represent at least some risk, better post-market surveillance of HIT is needed, steps should be taken to discourage practices that limit the free flow of information.

The committee report can be viewed here:  FDASIA Recommendations Draft 030913_v2

In addition, 39 comments were received in response to a request made by the three agencies involved (FDA, ONC and FCC). These comments can be found in Docket HHS-OS-2013-0003 at http://www.regulations.gov/#!docketBrowser;rpp=50;po=0;dct=PS;D=HHS-OS-2013-0003. The agencies have until January to complete the report.

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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