The FDA released another draft guidance intended to govern when a device maker submits a new regulatory filing for changes made to a 510(k) device, a document that drew substantial support from industry on several points. However, device makers are making the argument that the draft's discussion of changes to a device's intended use is inherently flawed, including the charge that the draft guidance has strayed into First Amendment issues. The August 2016 draft guidance followed an unsuccessful attempt in 2011 to revise the so-called K97 guidance, a holdover from the 1990s, but the pushback...

SINGAPORE – The wearable med-tech space saw a heated flurry of activity over the last year across Asia, but enthusiasm has cooled considerably as the obstacles that lie ahead for the sector become more apparent. Panelists speaking during the Asia Pacific Medtech Forum 2016 in Singapore emphasized that wearables will have to influence consumer behavior if they are to stay relevant. "If you look at wearables now, they are not medical-grade devices. It's very difficult for hospitals and practitioners to use them. From a start up point of view, we need to step up to...

SINGAPORE – Harmonization of regulations throughout the Asia Pacific region has been an ongoing goal in the past 20 years, but regulators across the region are now coming to accept that this particular goal may never be achieved. Regulators and industry stakeholders meeting in Singapore starting Tuesday for the Asia Pacific Medtech Forum 2016 said complete regional regulatory harmonization would be nice but is unlikely. While there has been some progress, a "harmonized regulatory environment will be impossible," said John Lim, deputy director of medical services at the Ministry of Health of Singapore. "If you...

After three-plus years, the FDA's device center has published the final version of a guidance for medical device reports (MDR), a document that seems little changed from the draft version. The agency held onto language found in the 2013 draft regarding investigational device exemptions and contract manufacturing arrangements, which critics of the draft had argued would lead to useless duplication of reports of device-related adverse events. The agency released the draft guidance in July 2013, stating at the time that a manufacturer would have to file a separate report for each and any device that...

Dublin-based Medtronic plc has won an investigational device exemption for its Harmony transcatheter pulmonary valve, after completing an early feasibility study of the device in patients with congenital heart disease (CHD). According to cardiologist Lee Benson, a professor of pediatrics at the University of Toronto, Harmony should prove to be "a game-changer for this very large patient population," but he also said more sizes of the device are needed for these patients. Medtronic unveiled data from an early feasibility study of the Harmony valve at TCT. That study, which initially enrolled 20 patients at three...

Sometimes the devil is in the details, but device makers had a broad set of concerns about the July draft guidance for the use of real-world evidence (RWE) in regulatory decision-making. Among the comments are those reflecting concern about the potential need for investigational device exemptions for some uses of RWE, and a perception that the scope of the draft seemed to exclude class II devices. The FDA released the draft guidance in July, stating that it would decide whether a proposed collection of data for generating RWE would require an investigational device exemption (IDE). Among the...

CLEVELAND – Addressing the state of health care innovation at the 2016 Medical Innovation Summit sponsored by Cleveland Clinic Innovations, a diverse panel of executives from disparate segments of the health care system agreed on one general principle: The industry is changing rapidly and in ways that look different from the face of innovation in any other industry. The reason, they also concurred, is that patient care is fundamentally different from other industries, where consumers might be willing to accept a lower priced model rather than the top of the line. "The difference with heath care is that patients don't...

CLEVELAND – Funding for health care innovation remains robust, according to a panel of venture investors at the 2016 Medical Innovation Summit sponsored by Cleveland Clinic Innovations. Although they found plenty to like across biopharma and med-tech, investors nevertheless voiced caution about excessive costs built into a system that talks value-based reimbursement but continues to deliver care on a fee-for-service basis. No single platform will transform that dynamic, according to Leslie Bottorff, managing director of health care investments for GE Capital, who said her organization is investing in an innovation ecosystem. "A few venture capitalists...

Abbott Laboratories and St. Jude Medical Inc. have kept analysts' busy this week, sifting through both companies' third quarter financials, looking for the read-through of Tuesday's $1.12 billion deal with Terumo Corp., trying to make heads or tails of Muddy Waters' latest cybersecurity attacks against St. Jude, all the while getting little clarity about the $5.8 billion elephant in the room otherwise known as Alere Inc. And yet, after nearly eight months of turbulence related to Abbott's pending merger with Alere, one of the most surprising takeaways from Abbott's...

The 2011 draft guidance governing when a change to a class II device should trigger a new regulatory filing was highly controversial, and Congress instructed the FDA to withdraw the document. However, Yarmela Pavlovic of the San Francisco office of Hogan Lovells told Medical Device Daily that the revised draft released in August is not only more nuanced, it also forces companies that previously may have been less than fully diligent about such matters to make the same effort as their more meticulous brethren. The Center for Devices and Radiological Health penned a new "510(k)...