Week Ending 05-04-18: The FDA, pre-certification, and the medical device industry
Statement from FDA Commissioner Scott Gottlieb, M.D., on New Efforts to Enhance and Modernize the FDA’s Approach to Medical Device Safety and Innovation
As digital transformation sweeps across the healthcare industry, the FDA is expanding their regulation of new technology through the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. In a statement released in April, the commissioner highlighted how the plan is intended to “bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs.” Read more.
The FDA is working to expand its medical device pre-certification processes, but some are concerned that the government agency won’t be able to keep up with the speed of innovation — potentially stifling progress. Bloomberg Law reminds us that FDA regulations are necessary and “there should never be a presumption that just because it is a software that it is automatically safe.” Read more.
With nine pre-cert companies, including Apple, Fitbit, Johnson & Johnson and more, the FDA is intent on “fostering innovation,” working to design a streamlined pre-certification program aimed at “establishing a standard of excellence with scalability and flexibility for different types of developers.” Common workflows are available online, with the FDA providing an opportunity to submit feedback and suggestions as development continues. Read more.
Two tech giants are coming together to get their share of the healthtech market. FDA pre-certified device company, FitBit, has enlisted Google Cloud services to increase collaboration between patients, customers and their doctors. The goal: “create a positive and lasting impact on human health.” Read more.
Australian wearable company, Global Kinetics Corp., is seeing the benefits of developing an FDA-cleared device. With more than $6M in funding, the device company that targets the effects of Parkinson’s disease is planning to use its funding to permeate the U.S. and global markets. Read more.