GHTF docs
This article was originally published in The Gray Sheet
Executive Summary
FDA is requesting 1comments by April 25 on Global Harmonization Task Force study group documents released in 2005, including the proposed guidances, "Principles of Medical Devices Classification," "Guidelines for Regulatory Auditing of Quality Management Systems - Part 2: Regulatory Auditing Strategy" (2"The Gray Sheet" Dec. 5, 2005, p. 18). The agency is also requesting feedback on the final documents, "Information Document Concerning the Definition of the Term 'Medical Device'" and "Essential Principles of Safety & Performance of Medical Devices" (3"The Gray Sheet" Aug. 1, 2005, p. 17)...
You may also be interested in...
GHTF Adverse Event Reporting Guidance Is A Stride Toward Harmonization
Adverse device side effects can go unreported as long as they are clearly identified in the manufacturer's labeling, according to a Nov. 17-posted Global Harmonization Task Force guidance document
GHTF To Draft New IVD Guidelines Following Expansion Of Device Definition
The Global Harmonization Task Force endorses the inclusion of in vitro diagnostics in further device-related harmonization efforts in a final document defining "medical device" released July 21
Interview: Theradaptive To Enter Clinical Trial For Spinal Fusion Gel
Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.