30 August, 2017
On 27 July 2017, the US Food and Drug Administration ("FDA") issued its Digital Health Innovation Plan, which discusses how FDA plans to restructure its regulatory approach of digital health devices. In particular, it discusses issuing new guidance for implementing legislation, a pilot Digital Health Software Precertification Program, and increasing digital health expertise within FDA. The Plan focused heavily on measures to streamline the regulatory pathway of digital health medical devices, particularly for low-risk products. This accords with Singapore's risk-based classification imposed by the Health Sciences Authority (HSA) on product registration for telehealth devices.
More details can be found in the Digital Health Innovation Plan here.
For further information, please contact:
Andy Leck, Principal, Baker & McKenzie.Wong & Leow
andy.leck@bakermckenzie.com
