January 28, 2020
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 Children’s Hospital, Biogen’s VP of innovation and external partnerships, and...
December 6, 2019
Digital health has gone global. On both sides of the Atlantic, healthcare stakeholders are evaluating these new tools, while innovators are navigating the pathways to implementation. It’s clear that while the North American markets and the European markets each have their own challenges, the industries also share plenty of universal opportunities and obstacles.
This week at the European...
November 19, 2019
Device regulation is a hurdle for any medical tech company, but doubly so for startups hoping to strike it big with their very first digital health product. With limited resources and experience, pushing a device through the FDA’s door and onto the market is a multi-year gauntlet of validation, documentation and, unfortunately, frustration.
To help young companies take a bit of the guesswork out...
November 1, 2019
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.
Let’s say I could show you,...
September 26, 2019
This morning the FDA released two guidance documents relating to the regulation of various digital health software devices.
The first is a draft guidance outlining categories of clinical decision support (CDS) products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-...
June 4, 2019
Since it was first announced, fans and critics of the FDA’s Pre-Cert program for medical software developers have mused on the benefits and burdens that might come with participation in the experimental program.
What to expect from Pre-Cert
The question has only become more pertinent since the agency released its 1.0 Working Model in January and, just a couple weeks ago, began seeking new De Novo...
May 22, 2019
The FDA has put out a call for new companies to test drive the current framework of its Digital Health Software Precertification Program, the ongoing effort to streamline regulation of digital health products prone to frequent update.
Organizations that are expecting to sponsor either a 510(k) submission or De Novo Request for a software as a medical device (SaMD) during 2019 or early 2020 are...
March 28, 2019
Within the last few years the FDA has undergone a metamorphosis when it comes to digital health regulations. Though many of these are not yet solidified, a recent report by PricewaterhouseCoopers (PwC) predicts that these changes could open new doors for pharmaceutical companies looking to jump into the digital arena.
“Changes made by the FDA have made it easier for digital health products to be...
February 6, 2019
The FDA released new draft guidance yesterday regarding premarket review for combination products — those with a mix of components that span across the agency’s drug, biologic and device product categories.
The proposed premarket guidance, which may still be adjusted based on public feedback, broadly advises industry to submit a single regulatory application within the pathway that most closely...
November 27, 2018
Yesterday, the FDA announced in a press release that it is eyeing potential updates to the agency’s 510(k) clearance pathway for medical devices. These could include a requirement for more modern predicate devices as well as objective safety and performance criteria during regulatory submission.
In the interest of promoting innovation, FDA Commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren,...