FDA ANNOUNCES AVAILABILITY OF GHTF STUDY GROUP GUIDANCES

The FDA has announced the availability of proposed and final documents prepared by Study Groups 1, 2 and 4 of the Global Harmonization Task Force (GHTF).

The documents include a proposal that may be used by governments developing and updating their regulatory requirements for medical devices.

Study Group 1 was tasked with identifying differences between various regulatory systems. Study Group 2 was tasked with developing guidance documents to be used in the exchange of adverse event reports. Study Group 4 was tasked with developing guidance documents on quality systems auditing practices.

The FDA announcement on the GHTF study groups can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/07d-0031-nad0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0031-nad0001.pdf).