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The first is a draft guidance outlining categories of clinical decision support (CDS) products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-...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The FDA released new draft guidance yesterday regarding premarket review for combination products — those with a mix of components that span across the agency’s drug, biologic and device product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,...
November 19, 2018
The FDA is seeking public comments for a proposed framework that would allow the majority of apps and software released by pharmas that accompany a drug treatment to avoid lengthy premarket review submissions.
According to a notice released last week, such software would be viewed as “promotional labeling,” and therefore only require submission to the FDA’s Office of Prescription Drug Promotion (...
September 17, 2018
Last week, as part of our Focus on Innovation, HIMSS Media ran a poll about the FDA's Pre-Cert program. The program isn't new, but we thought it would be a good moment to take the public pulse on a program that has seen a variety of reactions from inside the industry. Just under 500 readers responded.
In general, those opposed the program constituted a vocal minority — just 7.1 percent of...
September 11, 2018
Since new FDA Commissioner Scott Gottlieb announced the FDA precertification program, the agency has been moving full speed ahead to re-invent its process for clearing digital health products. Pre-Cert will emphasize a focus on evaluating “standards of excellence” for the company or firm, rather than focusing on specific products. The idea is that trusted shops will be able to iterate...
April 13, 2015
A brain training game fined by the FTC earlier this year.
Developers of mobile health apps need to be mindful of regulation from a number of different quarters. Among others, developers need to be aware of the FDA, OCR (HIPAA), and the FTC, which is increasingly regulating areas that would seem to be the purview of one of the other two groups.
At a HIMSS session on mobile and digital health...