In late September, the FDA released its final report on the Software Precertification Pilot Program, which it launched in 2017 to explore different regulatory approaches for digital health tools.
By 2022, the agency determined a new regulatory framework would be useful for software as a medical device, but it couldn't do that alone.
"We are not fully capitalizing on these capabilities and...
The digital health ecosystem has swelled to encompass a broad range of products over the years.
On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time...
It’s been quite a year: COVID-19, a change in administration and a year of transition for FDA digital health policy. In light of all the change and uncertainty, many digital health companies are struggling to decide upon a regulatory strategy for 2021.
My advice? If at all possible, stay away from FDA. They have enough to do right now. The people I know at FDA have been working 12- and 15-hour...
As healthcare becomes more digitized and clinical treatments shift away from one-size-fits-all therapies, the industry will need to become more critical about how it's employing and curating health data.
For vendors and providers, it's about understanding what tools are at their disposal and how they can be implemented to maintain and improve the standard of care. But for regulators like the FDA...
The FDA announced today the launch of the Digital Health Center of Excellence, a central resource intended to help the agency as well as external stakeholders promote digital health technologies.
Housed within the Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence (DHCE) will focus on a range of technologies "mobile health devices, Software as a Medical...
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug and combination product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.
Many appreciate that telemedicine...
The FDA released new guidance on digital health devices for treating psychiatric disorders that waives several regulatory requirements – such as need to submit a 510(k) premarket notification – for the duration of the COVID-19 emergency.
"Device availability may increase patient access to digital therapeutics while individuals are following 'stay at home' orders or practicing social distancing,...
Yesterday, Pear Therapeutics announced the regulatory clearance of Somryst, its prescription digital therapeutic for chronic insomnia. And while the product is noteworthy for these patients and Pear's broader business, it also stands as a major milestone for the digital health industry – the first product to be evaluated throught the FDA's Digital Health Software Precertification Program.
Now...
Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that were implemented on its devices without first securing 510(k) clearance, according to notices recently published by the FDA.
The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool were introduced in the Butterfly IQ Ultrasound System's 1.10.0 and 1.13.0 software...
Update: HIMSS20 has been canceled due to the coronavirus. Read more here.
About the author: Naomi Fried, PhD, is the CEO of Health Innovation Strategies, which provides digital health strategy and innovation-program design and optimization consulting to healthcare stakeholders including pharma, payers and providers. Her previous positions include the first chief innovation officer at Boston...
