Federal regulators have begun to transform the way they evaluate new high-tech health products, but it would be difficult to know from talking to technology entrepreneurs.
The recent high-profile dust-up between genetic test maker 23andMe and the Food and Drug Administration reflects the growing divide between tech firms and regulators in Washington over the industry’s ability to market health-related devices to consumers. But behind the scenes, another story has been playing out, one where the FDA has moved to revamp its procedures for evaluating new devices even as regulators and technology companies remain far apart in their views on how to balance innovation with safety.
These differences could have a real impact on the growing group of companies trying to transform medicine through technology. The FDA’s approach is poorly understood by some entrepreneurs. Others have no patience for what they see as overzealous government meddling. Some tech companies strongly disapproved of the FDA’s recent decision to stop 23andMe from marketing genetic testing kits to consumers.