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Medical Devices

December 16, 2019 | Daily News

Health stakeholders are praising Senate and House appropriators for permanently repealing the so-called “Cadillac” health insurance and medical device taxes in the end-of-year spending package released Monday (Dec. 16), following years of lobbying to get rid of the industry taxes Congress had passed to offset the coverage expansion in the Affordable Care Act.

December 16, 2019 | Daily News

Congress is slated to fully repeal three controversial health care taxes after congressional leaders agreed to include the repeals in an end-of-year spending package, sources familiar with the talks say.

December 11, 2019 | Daily News

Sen. Ted Cruz (R-TX) and other conservative lawmakers intend to pursue an expansion of FDA’s Parallel Track program if Stephen Hahn is appointed as FDA commissioner, even though FDA already has similar programs, such as Expanded Access, already in place, as well as a new pilot program, Project Facilitate.

December 10, 2019 | Daily News

The U.S. District Court of the District of Columbia ruled on Friday (Dec. 6) that FDA cannot regulate Genus Medical Technologies’ barium sulfate contrast agent as a drug because it qualifies as a medical device under the statute.

December 10, 2019 | Daily News

A top HHS official plugged the parallel review program between FDA and CMS as a key step to close what is sometimes a years-long gap between approval of new therapies and Medicare coverage decisions, and a CMS official said the agency hopes to better promote and support the program.

December 05, 2019 | Daily News

Biopharmaceutical venture fund and managed care organization experts believe FDA should stay out of the medical product pricing and value arenas and instead let the marketplace determine value.

November 25, 2019 | Daily News

FDA on Monday (Nov. 25) announced a series of steps to spur development of new ways to sterilize medical devices that don’t rely on ethylene oxide, including a voluntary pilot program under which companies that use ethylene oxide would submit a master file when changing locations or sterilization processes.

November 18, 2019 | Daily News

FDA cleared for marketing the first duodenoscope with a sterile, disposable elevator component, which is intended to reduce the number of parts that need to be cleaned and disinfected between uses, the agency announced Friday (Nov. 15).

November 13, 2019 | Daily News

Two FDA experts say 2020 presidential hopeful Sen. Elizabeth Warren’s (D-MA) plan to weed out government corruption by restricting how companies share data and information with federal agencies could have a chilling effect on FDA and regulated industries.

November 11, 2019 | Daily News

FDA is laying the groundwork to study how the general public interprets drug promotion.

October 24, 2019 | Daily News

In a new draft guidance published Wednesday (Oct. 23), FDA recommends breast implant manufacturers include a boxed warning and patient decision checklist in the labeling for breast implants.

October 23, 2019 | Daily News

Experts from Harvard Medical School and Yale School of Medicine call for FDA to enhance postmarket evaluation and premarket testing of medical devices approved through the 510(k) pathway -- which would require more investment in technologies that leverage real-world data, and more authority for FDA to mandate postmarket studies and prohibit certain devices from being used as predicates in device clearances.

October 21, 2019 | Daily News

Democratic presidential candidate Sen. Elizabeth Warren (D-MA) wants FDA to elaborate on how it will differentiate between device servicers and device remanufacturers and how it will promote compliance among those that consider themselves servicers but that are in fact remanufacturers.

October 17, 2019 | Daily News

The medical device lobby called on President Donald Trump to seek a repeal of the Affordable Care Act’s medical device excise tax, which is set to kick back into effect at the beginning of 2020.

October 15, 2019 | Daily News

As FDA parries arguments that its approval standards have changed, allowing for therapies to get on the market faster with little evidence, former FDA chief Robert Califf told a group of stakeholders in the data industry that he, too, is worried that a number of new treatments are getting on the market with no actual understanding of clinical benefit and risk.

October 01, 2019 | Daily News

FDA notified device manufacturers, providers and patients on Tuesday (Oct. 1) that connected medical devices and health care networks that use certain communication software are vulnerable to potential cybersecurity attacks.

September 30, 2019 | Daily News

A medical software industry lawyer called out what he sees as “absolutely horrible” and “legally wrong” language in the revised version of FDA’s clinical decision support software (CDS) draft guidance, which clarifies which CDS tools under the provisions of the 21st Century Cures Act are no longer classified as medical devices and thus are not regulated by FDA.

September 27, 2019 | Daily News

FDA is creating new Sentinel Coordination Centers via a five-year contract as part of its bid to grow the agency’s flagship Sentinel System into a vigorous national scientific resource, the agency announced Friday (Sept. 27).

September 27, 2019 | Daily News

FDA on Thursday (Sept. 26) finalized software policy guidance that clarifies which clinical decision support (CDS) tools won’t be considered devices and thus can get around agency enforcement oversight.

September 24, 2019 | Daily News

The use of medical devices in combination with biologic medicines is emerging as a way to ease burdens on patients and reduce health care costs, but the products pose regulatory challenges to FDA, agency drug center director Janet Woodcock told stakeholders Monday (Sept. 23).