The Regulators Role in Improving Standards to Support International Harmonization – International Medical Devices Regulators Forum [IMDRF] Standards Working Group

Guest Speaker -

Scott A. Colburn, CAPT, USPHS

Director, CDRH Standards Program

FDA/CDRH/OCD

Standards offer important technical tools to assess medical devices. They can streamline the device review process, improve the efficiency of regulations and establish productive dialogue among regulators, manufacturers, clinicians and the public.

With the greater use of commonly accepted standards among regulators comes harmonization, which supports IMDRF’s mission: ‘…to strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety.’

The IMDRF believes that collaboration with SDOs and its stakeholders will lead to advances in global regulatory harmonization. For manufacturers, harmonization will help speed products to market, and promote international trade and market integration. Patients will benefit from improved access to life-saving and life-enhancing treatments and SDOs will enjoy greater success as standards grow in relevance and utilization.

This presentation will outline the efforts members of the IMDRF Standards Working Group are taking to improve standards for regulatory purposes.