Update Feb.7, 07

Back
... Up One Level
Next

Update Feb 7, 2007

Feb. 7, 2007
Role of Standards in the Assessment of Medical Devices

The above titled document was recently published by the Global Harmonization Task Force (GHTF), a voluntary group of representatives from medical device regulatory authorities and the regulated industry. The Task Force was conceived in 1992 in an effort to respond to the growing need for international harmonization in the regulation of medical devices. Its objective is to encourage convergence at the global level in the evolution of regulatory systems for medical devices in order to facilitate trade whilst preserving the right of participating members to address the protection of public health by those regulatory means considered the most suitable.

The primary way in which the Global Harmonization Task Force (GHTF) achieves its goals is through the production of harmonized guidance documents suitable for implementation or adoption by member Regulatory Authorities, as appropriate taking into account their existing legal framework, or by nations with developing regulatory programmes. Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.

The organization has issued many Final documents in areas such as Pre-market and Post-market submissions, Quality Systems and Auditing. The organization has a few proposed documents as well and recently released a revised document titled, “Role of Standards in the Assessment of Medical Devices” and is seeking comments from interested participants so that a final guidance document can be made available soon.

The guidance in question describes the role of technical standards both during the design of a medical device and subsequently to demonstrate a device conforms to essential safety and performance criteria. The purpose of the document is to:

encourage and support the development of international consensus standards for medical devices to demonstrate compliance with the Essential Principles of Safety and Performance of Medical Devices
encourage manufacturers to comply with appropriate international standards;
persuade Regulatory Authorities to introduce a mechanism for recognising standards that provide manufacturers with a method of demonstrating compliance with the GHTF harmonised Essential Principles;
support the concept that in general, the use of standards is voluntary and manufacturers have the option to select alternative solutions to demonstrate their medical device meets the relevant Essential Principles.

The FDA wants your comments.
You can access the proposed Guidance Document, please use the following link:
http://www.ghtf.org/sg1/sg1-proposed.html

If you have comments regarding this update, please contact Romil Rambhia at 516-482-9001 or email at romil@mdiconsultants.com

Internet Presence, Creation, Design & Maintenance by: Windco.com, Inc