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FDA Issues Clinical Data Presentations for Orthopedic Device Applications

Rockville, Maryland, USA, December 02, 2004.    FDA has published a Guidance for Industry to recommend the content of clinical data information supporting orthopedic device applications.

The guidance, split into 8 sections, describes the information that the Agency expects during reviews of 510(k) and PMA submissions.  The final section provides a list of elements the FDA recommends be included in clinical data presentations for these submissions to "encourage consistency and enhance understanding between FDA and sponsors through a consistent vocabulary when discussing and presenting clinical data."

FDA Issues Clinical Trial Computerized Systems Guidance

Rockville, Maryland, USA, September 17, 2004.    FDA has revised a Guidance for Industry concerning requirements for Computerized Systems used in Clinical Trials.  The main focus of the guidance appears to be confirmation of the relevancy of the August 2003 Final Guidance on Part 11 to Clinical Trial Computerized Systems, electronic records, and electronic signatures, and how the Agency expects Clinical Trial establishments to conform to the Part 11 Regulation whilst the  regulation is being re-examined and a revision to the regulation is being developed, targeted for release in 2005.  The Guidance is a revision (Revision 1) to an earlier guidance which was issued in 1999 with the same title.

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You can stay ahead of these changes in the USA, EU, Canada, and virtually everywhere on the planet by subscribing to StdsRadar.  For a no obligation quote, contact us at stdsradar@crogroup.com.

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