FDA’s medical gas guidance offers clarity to manufacturers

FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]

Webinar: How late 2017 has changed medtech – Oct. 11

Wednesday, October 11, 2017 2:00 PM EST / 11:00 AM PST       When it comes to news out of the U.S. government: one word could sum up what it means for the medical device industry: “uncertainty.” It was true at the start of 2017. And it is even truer today. The effort to

FDA cuts could threaten medtech innovation: Here’s why

The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advisers (MCRA). Glenn Stiegman, MCRA Innovation is a vital element of success for medical device companies. More than 6,500 U.S. companies are developing technologies that improve patient outcomes. This represents a

FDA to pilot new high-risk PMA for medical devices

The FDA is readying a pilot program to try and improve the pre-market approval process for high-risk medical devices later this month. The federal safety watchdog is seeking nine companies to participate in its Premarket Approval Application Critical to Quality program beginning Sept. 29 and running to either Dec. 31, 2018, or until nine PMAs […]

FDA releases final guidance on medical device interoperability

The FDA this week released final guidance on interoperability in medical devices as more and more healthcare related electronics connect to the Internet of Things. “As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange information and use information that […]

How to work with the new FDA

Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH. Lisa Olson, RCRI Scott Gottlieb has now settled into his role as FDA’s new commissioner and is putting his stamp on the agency. Interestingly, he has started with some very specific points of focus that have bubbled to

Medical device regulation: How it’s changing in the U.S. and Europe

Mary Beth Ritchey, RTI Health Solutions This is a busy year for medical device regulation in the United States and Europe. U.S. medical device regulation legislation In the U.S., the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) is due to expire Sept. 30. A new bill including updates for medical devices has

Serious medical device recalls nearly doubled in Q2

Medical device recalls at the Class I level were up 88% during the second quarter of 2017, and the major culprit was quality issues involving device part malfunctioning, according to a new report from Stericycle ExpertSolutions. Quality played a significant role among the 15 serious medical device recalls during the second quarter, partly because it encompasses such

5 medtech funding insights you need to know

Venture capital funding isn’t what it used to be for medical device startups, but there are actually reasons to feel optimistic about medtech funding. That was the big takeaway from a four-expert panel at DeviceTalks Minnesota last month. (The next DeviceTalks is Oct. 2 in Boston.) Charlie Whelan, director of transformational health consulting at Frost & Sullivan,

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Here are the top 5 medtech stories of mid-2017

The middle of 2017 is shaping up to be a continued whirlwind of activity for medtech. FDA is getting used to its new leadership but is facing a continued lack of clarity on user fees and UDIs. Industry is seeing a deeper consolidation in medical supplies, exemplified in Cardinal Health’s purchase of patient recovery supplies from

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Why U.S. first may be the new medical device development strategy

Increased regulatory hurdles in Europe and China could mean more medical device development focusing on the U.S. market first. That seemed to be a major takeaway from panels on regulation and reimbursement at Healthegy’s Medtech Conference, held last week in Minneapolis. “We’re actually going to be doing more early clinical work with the FDA,” said Stacey Pugh, vice

FDA announces regulatory updates under 21st Century Cures Act

The 21st Century Cures Act aimed – among other things – to amend the Federal Food, Drug, and Cosmetic Act to more closely align device and drug regulations. FDA is updating regulations to reflect some of the 6-month-old law’s changes. Details can be found in today’s Federal Register. Specifically, the 21st Century Cures Act amended Humanitarian Device

FDA extends UDI compliance date for low risk devices

Labelers of class I and unclassified devices recently got a reprieve when FDA announced an extension of the compliance date for unique device identification (UDI). Makers of devices such as manual surgical instruments and mechanical wheelchairs will have 2 extra years to get these devices submitted to the Global unique device identification database (GUDID), FDA announced last

Why X-rays in shoe stores were a really bad idea

Vanessa Burrows, FDA historian X-rays have enhanced healthcare in a variety of ways since their discovery in the late 19th century. But like many cutting-edge scientific developments, the technology has also inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA’s history video

5 officials running healthcare under Trump

President Donald Trump’s critics complain that the president has yet to make hundreds of appointments to midlevel positions. But at least with healthcare, we’re starting to get a clearer picture of who is in charge. Just on May 10, the U.S. Senate confirmed Dr. Scott Gottlieb as FDA commissioner. Here are 5 top officials shaping

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