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Medical Devices

June 03, 2019 | Daily News

Days before the House Appropriations Committee is set to mark up an FDA funding bill, an expert on the agency’s budget process said there are plenty of challenges looming ahead that could sink the $184 million increase that House lawmakers propose in the bill.

June 03, 2019 | Daily News

The medical device lobby praised an interagency report that calls for increased research on potential pain management devices, such as neuromodulation devices and interspinous process spacer devices.

May 30, 2019 | Daily News

A medical device regulatory expert raised concerns that companies may see no benefit from participating in FDA’s newly announced plan to test its software precertification program, and, given the added burdens of doing so, there might not be enough volunteers to properly test the program.

May 28, 2019 | Daily News

Despite lingering questions surrounding FDA’s authority to implement its software precertification program, the agency is moving forward with a pre-cert test program in which it hopes to test out its pre-cert model with a range of software companies.

May 16, 2019 | Daily News

The Senate Finance Committee has established group tasked with examining the Affordable Care Act’s 2.3% excise tax on medical devices, which will kick back in Dec. 31, unless repealed or again delayed, among other health-related taxes.

May 10, 2019 | Daily News

Senate health committee ranking Democrat Patty Murray (WA) sent letters to three duodenoscope makers -- Olympus, Pentax and Fujifilm -- asking about their plans to respond to FDA’s findings that the number of high-concern organisms found on reprocessed duodenoscopes is nearly 2.5% more than what the agency originally reported back in 2018.

May 07, 2019 | Daily News

Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests.

May 07, 2019 | Daily News

Sen. Bill Cassidy (R-LA) suggested Tuesday (May 7) that lawmakers may need to weigh how patient privacy could be affected by third-party apps accessing health data, and Senate health committee Chair Lamar Alexander (R-TN) agreed that area needs lawmakers’ attention.

May 06, 2019 | Daily News

FDA will take a range of actions to increase the agency’s uptake of breast implant adverse event reports and registry data, and will also make sure patients and providers are aware of the potential risks of such products by publicizing adverse events that were in a hidden database.

May 06, 2019 | Daily News

Following through on its obligations under the Medical Device User Fee Amendments of 2017, FDA is seeking input from patients as it formulates policies on premarket clinical studies, benefit-risk assessments and postmarket evaluation of medical devices.

May 02, 2019 | Daily News

CMS Administrator Seema Verma on Thursday (April 2) announced the agency is changing the process for issuing Healthcare Common Procedure Coding System codes to give drug and device makers more opportunities to apply for them, and directed contractors to follow the Local Coverage Determination process for every decision rather than opt to automatically not cover technologies with temporary codes for emerging technology.

April 29, 2019 | Daily News

The American Society for Radiation Oncology is urging Congress to revamp the prior authorization process, which oncologists surveyed by the group say delays cancer treatments.

April 25, 2019 | Daily News

Leading consumer advocacy groups say the public health stakes are high in a Freedom of Information Act (FOIA) case heard by the Supreme Court this week, warning in an amicus brief that a decision to tighten restrictions on what information can be released would virtually dry up data the groups have obtained from FDA.

April 25, 2019 | Daily News

A leading pediatric neurologist said he welcomed FDA’s approval of the first-ever device for treating attention-deficit/hyperactivity disorder (ADHD).

April 25, 2019 | Daily News

FDA issued draft guidance on Tuesday (April 23) that the agency hopes will help all FDA-regulated industries prepare for potential future voluntary recalls and work quickly when they happen.

April 23, 2019 | Daily News

CMS proposes raising the add-on pay for new technology and providing a path for breakthrough devices approved by the FDA to access add-on payments as part of the proposed fiscal 2020 hospital inpatient pay rule released Tuesday (April 23) -- a move the medical device lobby praised for including several of the industry’s suggestions.

April 23, 2019 | Daily News

FDA again is extending the period of time during which it will not enforce certain combination product postmarketing safety reporting requirements, the agency announced via an updated guidance on Tuesday (April 23).

April 23, 2019 | Daily News

A month after reporting it received tens of thousands of adverse events associated with surgical staplers and staples, FDA is stepping up its regulation of the devices by: issuing a proposed order to upclassify the Class I devices as Class II; issuing draft guidance on labeling recommendations to ensure adequate use; and scheduling a public meeting on May 30 to gather input on the first two efforts.

April 22, 2019 | Daily News

In the wake of a 35-day partial government shutdown that furloughed 41 percent of the agency’s staff earlier this year, a group of FDA policy experts sent a letter to the agency asking for more details on how much funding FDA had and from what sources; exactly how many personnel were exempted, excepted and furloughed throughout the shutdown; and how FDA is preparing for future shutdowns.

April 19, 2019 | Daily News

As part of a broader effort to reconsider its regulation of implantable medical devices, FDA on Thursday (April 18) announced the release of a draft guidance detailing the types of information manufacturers should include in premarket submissions for devices containing nitinol, an alloy of nickel and titanium.