The FDA planned a public workshop for mid-September to discuss the recently released draft guidance regarding regulation for mobile medical apps. The guidance includes a fairly narrow subset of medical apps, covering those that are used as accessories to medical devices and those that transform a mobile platform into a regulated medical device. “The use […]
The FDA released a new guidance yesterday detailing the agency’s process of making benefit-risk determinations when assessing premarket applications for medical devices for “reasonable assurance of safety and effectiveness.” The agency hopes to provide clarity for both industry and its reviewers by outlining what sorts of factors are taken into consideration when considering PMAs, the […]
The FDA took bold steps to outline expectations for medical device premarket submissions in the release of a new draft guidance that outlines the basic structure for clinical trials. The document attempts to the foundational features of medical device trials, including what types of studies may be appropriate, how to avoid bias in subject or […]
One long-running complaint, among the litany of complaints, about the U.S. Food and Drug Administration revolves around reviewers at the Center for Devices and Radiological Health. Some say when reviewers change, all consistency in the assessment of new innovative medical devices is lost. Some argue that reviewers are not experienced enough and ask the wrong questions. […]
How can there be speedy, early assessments of new innovative medical devices? The U.S. Food and Drug Administration and the Minnesota medical device community may have hit upon an answer. At the close of a two-day visit to Minnesota Tuesday by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, and […]
The U.S. Food and Drug Administration’s certification of medical devices lacks the legal framework to be a “reliable premarket screen” and should be scrapped, according to the Institute of Medicine’s long-awaited 510(k) assessment. Specifically, the IOM’s 510(k) report noted that the 510(k) approval process “cannot be transformed into a premarket evaluation of safety and effectiveness […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
There will be no retaliation against companies who tell the U.S. Food and Drug Administration that its processes are too burdensome and unpredictable. Those are the words of Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, according to a report by FDA News’ Device and Diagnostics Letter. Last week, Shuren […]
A new survey critical of the U.S. Food and Drug Administration’s 510(k) review process makes important suggestions for improvement, but is not representative of the industry as a whole. That was the response of Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who participated in a panel Tuesday to discuss results […]
Since he assumed his post in January, Dr. Jeffrey Shuren, the top Food and Drug Administration official on medical devices, has walked a delicate tightrope. He has worked hard to reassure a nervous industry that the FDA still values innovation, but has not promised anything specific. But listening to his remarks, an informal understanding seems […]
Minnesota’s medical device companies have openly fretted about the Food and Drug Administration altering or even eliminating the popular 510(k) clearance program. From venture capitalists and entrepreneurs to doctors and academics, the industry has complained that the FDA is already taking too long to make decisions, a harbinger of worse things to come. And since […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
At a time when medical device companies are facing challenges like the $20 Billion excise tax (part of national health care reform), there is industry-wide concern that FDA will increase the regulatory burdens necessary to bring new technology to market, thus increasing time to bring life-enhancing products to patients, and increasing costs. There is already a dearth of early-stage start-up funding available in many parts of the country, and an increasingly burdensome and unpredictable regulatory process only hurts the ability of promising companies to attract what little start-up money exists.
As a journalist, I’m frequently beset with impulsive self-righteousness. Which is why I jumped the gun a bit this week. I wanted to attend the Med Tech Investment conference in Minneapolis this past week, specifically a speech by Dr. Dan Schultz, the former head of the Center for Devices and Radiological Health (CDRH) at the […]
“This is all about patients,” Dr. Susan Alpert, Medtronic Inc.’s top regulatory officer, told Food and Drug Administration officials Tuesday at a town hall meeting in Bloomington, Minnesota. But was it? For all of the venture capitalists, CEOs, doctors, and industry consultants Minnesota’s medical device community threw at Dr. Jeffery Shuren, there was not one […]
