FDA cuts back oversight of medical device data systems

FDA cuts back oversight of medical device data systems-massdevice: MASSDEVICE ON CALL — Makers of medical device data systems caught a major break this month as FDA regulators ruled that devices that collect and store information generated by other devices can' skip the 510(k) process for premarket clearance.

US FDA outlines plans for device review process improvements

US FDA outlines plans for device review process improvements-massdevice: Following third-party process improvement recommendations issued in late 2013, the US Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has laid out a two-stage plan to implement those changes for medical device reviews.

FDA Formula Allows Tweets About Products Without Excessive Risks

FDA Formula Allows Tweets About Products Without Excessive Risks-thegraysheet: FDA suggests a simple formula for companies to use in sending twitter messages about their products. The question is how many products have benefits and risks that can be conveyed within the 140 character limitation of a tweet. The agency explained how firms can promote their products on social media platforms like Twitter in a draft guidance (PDF), “Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”

FDA takes on Twitter and other online etiquette for medtech makers

FDA takes on Twitter and other online etiquette for medtech makers-massdevice: FDA regulators published a pair of new draft guidances this week to provide clarity on its stance regarding online communication in challenging situations, especially via character-constrained channels such as Twitter or when responding to misinformation posted online.

VA chief: More vets wait 30 days for appointment

VA chief: More vets wait 30 days for appointment-politico: About 10 percent of veterans seeking medical care at VA hospitals and clinics have to wait at least 30 days for an appointment — more than twice the percentage of veterans the government said last week were forced to endure long waits, the acting Veterans Affairs secretary said Wednesday. Sloan Gibson said the higher number of veterans waiting 30 days or more is revealed in a report due out Thursday. He called the increase unfortunate, but said it was probably an indication that more reliable data was being reported by VA schedulers, rather than an actual increase in veteran wait times.

More Time To Respond To CDRH Classification Reform Proposal

More Time To Respond To CDRH Classification Reform Proposal-thegraysheet: FDA will give companies and other stakeholders an additional three months to provide written comments in response to the agency’s March 25 proposed updates to medical device classification regulations. The agency says it is responding to feedback that the initial 90-day comment period scheduled to expire on June 23 “does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.” The new comment deadline is Sept. 22.

Irish Eyes May Smile On Medtronic-Covidien Tax Rates, But There Is More To It, Execs Say

Irish Eyes May Smile On Medtronic-Covidien Tax Rates, But There Is More To It, Execs Say-thegraysheet: Medtrode Inc. and Covidien PLC executives argue that their mammoth $42.9 billion merger is about much more than just the tax benefits. The firms fit together like a glove, they say. The tax-inversion element of the acquisition – where Medtronic will move its legal domicile to Ireland, where Covidien is headquartered, to take of advantage of lower tax rates – is attracting most of the deal’s publicity so far, with good reason: Medtronic has upwards of $14 billion in cash on hand, but much of it is overseas, shielded it from a big U.S. tax penalty.

ANVISA proposing eased registration for lower-risk medical devices

ANVISA proposing eased registration for lower-risk medical devices-massdevice: Brazilian medical device market regulators have initiatedpublic consultations on proposals that could significantly reduce registration and re-registration requirements for Class I and II devices.

Senate bill would double veterans' health spending

Senate bill would double veterans' health spending-politico: Spending on veterans' health care could double in three years under the Senate's solution to the long waits experienced by thousands seeking medical care at VA hospitals and clinics, according to congressional budget experts. Analyzing a bill the Senate passed overwhelmingly last week, the Congressional Budget Office estimates the measure would cost $35 billion over the next three years to build new clinics, hire doctors and make it easier for veterans who can't get prompt appointments with VA doctors to get outside care.

CDRH Offers Primer On Its Guidance Priority-Setting Process

CDRH Offers Primer On Its Guidance Priority-Setting Process-thegraysheet: CDRH annually prioritizes about one-third of the guidance documents it hopes to get out quickly and continuously analyzes its own progress. Nonetheless, limited resources and congressional input means that not all prioritized documents will be issued before the fiscal year ends, a device center policy official says. Phil Desjardin, associate director for policy at CDRH, discussed the center’s priority-setting process and, with other FDA managers, took feedback from industry and advocacy groups during a meeting held earlier this month at FDA’s headquarters in Silver Spring, Maryland. 

Global partnerships advance the regulatory science that protects public health

Global partnerships advance the regulatory science that protects public health-politico: Premier has identified 86 hospital acquired conditions that harm patients and raise costs — far more than the list CMS uses to adjust hospital payments. The hospital safety study was based on a Premier Inc. examination of 5.5 million hospital discharge records from 2013. It identified 86 potential inpatient complications associated with increased risk of mortality, length of stay and cost. The research was published in the American Journal of Medical Quality.

The man who upended the Republican Party

The man who upended the Republican Party-politico: For Dave Brat, the newfound Republican sensation who is expected to breeze through the general election in this conservative district, the attention, scrutiny and interview requests will only intensify. In dozens of interviews with the 49-year-old’s colleagues, students and neighbors, and in an examination of his published writing, a portrait emerges of a popular local professor who’s well-liked by colleagues and students, always makes time for his students if they need it, and loves to talk about issues and ethics. His approach is far more theoretical than the practical, policy-oriented way favored by most Washington politicians.

FDA Partially Finalizes UDI Database Guidance, With More To Come

FDA Partially Finalizes UDI Database Guidance, With More To Come-thegraysheet: FDA finalized guidance for companies making submissions to its global unique device identification database today – sort of. In an usual move, the agency decided to finalize specific sections of the guidance, while maintaining draft status for other parts. “To provide labelers with the most accurate information as soon as it is available, we are finalizing this document in two phases,” the agency writes in a notice announcing the new guidance (PDF). The first part of the finalized guidance, which is now available, addresses the issues that received the most comments and questions. The updated version of the guidance will officially be published on June 11.

White House Threatens To Veto House Approps Bill That Holds $20 Million From FDA

White House Threatens To Veto House Approps Bill That Holds $20 Million From FDA-insidehealthpolicy: The White House Tuesday (June 10) threatened to veto the House Appropriations Committee's agricultural funding bill in a letter raising myriad concerns with the legislation, including a provision witholding $20 million from FDA's salaries and expenses until guidance is finalized on abuse-detterrent formulatons of opioids and lawmakers' refusal to include user fees to support a prevention-based food safety system.

AdvaMed Solidifies Its Presence In China

AdvaMed Solidifies Its Presence In China-thegraysheet: AdvaMed has received approval by the Chinese authorities to open a representative office in Shanghai, a move that the organization expects will enhance its ability to advocate for issues with local officials and other stakeholders. Many AdvaMed members have their China headquarters in Shanghai. The association expects that China's official recognition of the Shanghai office will make it easier to establish partnerships with Chinese authorities and other stakeholders, and provide its members more opportunities to engage on important policy topics in “one of the world’s fastest growing markets for medical technology.”

13k students get live, front-row seat to surgery with Google Glass

13k students get live, front-row seat to surgery with Google Glass-massdevice: MASSDEVICE ON CALL — Some 13,000 students around the world watched live as U.K. surgeon Dr. Shafi Ahmed performed tumor resection surgery while wearing Google Glass. Ahmed not only opened his operating room, he took questions during surgery from students who typed them in online. The questions were displayed on Ahmed's Google Glass, appearing in the bottom left-hand side where they did not obstruct his vision during surgery.

No more secrecy in medtech pricing, says Sen. King

No more secrecy in medtech pricing, says Sen. King-massdevice: Senator Angus King (I-Maine) has a new bill on the floor that he says will correct a fundamental imbalance in the medtech market, namely by imposing more pricing transparency on medical device makers. He started out researching the controversial medical device tax, he said on the Senate floor this week, but his research into medtech's share of the cost of U.S. healthcare hit a wall when he couldn't turn up information on how much hospitals are paying for various implantable devices. Given the growing emphasis on reigning in healthcare costs, the lack of transparency in medical devices may be hindering market forces that may otherwise help lower prices, King said.

FDA Glucose Meter Draft Guidelines Attract More Criticism From Congress

FDA Glucose Meter Draft Guidelines Attract More Criticism From Congress-thegraysheet: Two FDA draft guidance documents on professional and over-the-counter glucose meters were singled out for more criticism in a May 30 letter (PDF) from 85 House Democrats and Republicans to Commissioner Hamburg. “We are concerned that the draft guidances issued by FDA impose challenging requirements for accuracy that are inconsistent with internationally recognized standards,” members of the congressional Diabetes Caucus write, echoing complaints that have been lodged by meter makers, clinicians and lab managers.

CDRH Looks For Input On Guidance-Development Practices

CDRH Looks For Input On Guidance-Development Practices-thegraysheet: FDA’s device center will seek feedback on its guidance development process at a June 5 workshop at is Silver Spring, Maryland, headquarters. The agency also plans to discuss best practices for guidance development and how the device center sets it guidance priorities.