Medical Device Link.

Guidelines created by the Global Harmonization Task Force (GHTF) arose due to the perceived need for consistent regulation of medical devices on a global scale. The organization, developed by regulatory and industry representatives from the European Union, United States, Canada, Japan, and Australia, gives member countries a say in how rules that regulate medical devices globally evolve.

The goal of the GHTF is the development of equivalent systems that protect public health and facilitate trade with member countries. There is also the hope that less experienced countries will look to the GHTF Guideline, entitled Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers, in the formation of their regulatory documents. FDA has not yet granted official status to the GHTF Guideline, but evidence shows the Guideline and FDA regulations bear similarities to each other and, in some cases, are mirror images. The few discrepancies that can be found are small enough as to be insignificant.

One such discrepancy can be found in Section 7 of the GHTF Guideline (www.ghtf.org/sg4/inventorysg4/99-28genreq.doc). The Guideline specifies the scope of an audit (i.e., inspection) in terms of the following: 1) the particular medical devices controlled by the quality system under audit, 2) the quality system requirements against which the quality system is under audit, 3) the type of audit, and 4) the actual location of the audit. FDA's quality system inspection technique (QSIT)

Consistency and convergence of the rules that govern regulation go a long way towards guaranteeing that medical devices will continue to be subjected to adequate testing and inspection. The Guideline aims at encouraging "convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices, promoting technological innovation and facilitating international trade, and the primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices." The GHTF hopes that the release and adoption of a common set of guidelines for member countries will encourage the rest of the world to adopt these guidelines as well. Official FDA endorsement of the GHTF Guideline doesn't sound like that bad of an idea and, in fact, jives with its current policies.