FDA: Page 73
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HHS pitches sweeping revamp of Anti-Kickback Statute, Stark Law
Several new safe harbors are proposed to encourage value-based care, allow patient engagement through furnishing of tools and supports, and permit certain remuneration in some CMS-sponsored models.
By David Lim • Oct. 9, 2019 -
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AI clinical support opens physicians to potential liabilities: JAMA
Legal considerations for doctors using clinical decision support software come amid challenges for regulators attempting to define a framework to oversee the emerging technologies.
By David Lim • Oct. 7, 2019 -
Explore the Trendline➔
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
IMDRF cybersecurity guidance favors total product life cycle approach
The International Medical Device Regulators Forum's draft mirrors U.S. regulators' support for a total product life cycle strategy, but does not include a tiered approach to categorizing risk laid out by FDA last year.
By Nick Paul Taylor • Oct. 3, 2019 -
Some Class I devices could get 4 extra years to comply with EU MDR
The European Union's Medical Device Coordinating Group met with medical device stakeholders Monday in advance of an expected vote on a corrigendum to amend or modify some parts of major upcoming EU regulatory changes.
By Dana Elfin • Oct. 2, 2019 -
DME industry pans CMS' gap-fill proposal, but agrees current system is "fundamentally flawed"
CMS' proposed framework to compare new technology to older items is not sufficiently fleshed out and isn't transparent enough, the American Association for Homecare said.
By David Lim • Oct. 2, 2019 -
Sterigenics abandons effort to reopen Willowbrook ethylene oxide sterilization facilities
The company behind the major medical device sterilization plant said it is "actively taking steps to ensure customer and patient needs continue to be met by our other facilities."
By David Lim • Sept. 30, 2019 -
TÜV Rheinland designated as notified body under MDR
The approval by European authorities gives medical device companies another entity to turn to as they scramble to get ready for the 2020 implementation.
By Nick Paul Taylor • Sept. 27, 2019 -
FDA revises clinical decision support software draft after industry blowback
The decision to revise the draft guidance comes after feedback on the 2017 version asked the agency to reconsider its approach, Bakul Patel, FDA's director for digital health, told MedTech Dive.
By David Lim • Sept. 26, 2019 -
Brian Tucker
Device chief says FDA could be open to making breakthrough designations public
The number of breakthrough designations has doubled every year since the program's 2016 inception, and "you're going to start seeing this [number of approvals] steamroll," FDA's Jeff Shuren said at The MedTech Conference.
By Dana Elfin • Sept. 26, 2019 -
Jacob Bell / BioPharma Dive
FDA offers guidance on filing device applications electronically
The draft is the precursor to a series of documents that will detail the submission formats and implementation timelines for specific types of regulatory applications.
By Nick Paul Taylor • Sept. 26, 2019 -
EPA delays ethylene oxide sterilizer rule timeline amid industry pushback
Separately, it is unclear how long it will be until a second proposed rule that aims to address air pollution emissions from the ethylene production process is published.
By David Lim • Sept. 25, 2019 -
To pitch Pre-Cert to Congress, FDA builds a case first
Enforcement mechanisms and the decision of how the experimental pathway will fit into the current 510(k), De Novo and PMA routes are among the details lawmakers will need to eventually address, an agency official said.
By Kim Dixon • Sept. 25, 2019 -
National Institute on Drug Abuse, National Institutes of Health
FDA grants breakthrough status to Aurora's concussion treatment
The non-invasive device uses near-infrared light to accelerate recovery from concussion.
By Nick Paul Taylor • Sept. 25, 2019 -
AdvaMed
Public health alert or legal advertising? It can be hard to tell.
AdvaMed applauded the FTC's move to send letters warning lawyers and lead generating firms over potentially unfair and deceptive ads seeking clients for personal injury suits.
By Dana Elfin • Updated Sept. 26, 2019 -
AdvaMed pegs medical device tax repeal hopes on year-end legislative package
A letter Tuesday from more than 600 other stakeholder organizations urges congressional leadership to permanently repeal the tax. But Stryker CEO Kevin Lobo said Monday a multi-year suspension is the most likely scenario.
By David Lim • Sept. 24, 2019 -
Adobe Stock
FDA tries to spur patient shaping of clinical trial design with draft guidance
"Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate," acting FDA Commissioner Ned Sharpless said in a statement.
By Nick Paul Taylor • Sept. 24, 2019 -
EU changes for IVDs called a 'sea change,' revolutionary
The new in vitro diagnostic regulation, slated to come into effect May 2022, will for the first time subject as many as 90% of these diagnostics to review. Previously, most companies could self-certify.
By Dana Elfin • Sept. 23, 2019 -
FDA lays out vision for device conformity testing pilot
The agency issued draft guidance proposing a program to accredit testing labs that would perform premarket evaluations for device makers to determine if a product earns a declaration of conformity.
By Susan Kelly • Sept. 23, 2019 -
Getty Images
US exempts X-ray components, other devices from China tariffs
Varian said certain components sourced from China for linear accelerators made in the U.S. were exempted.
By David Lim • Updated Sept. 24, 2019 -
Jacob Bell
NESTcc, ophthalmic imaging first up in FDA medical device 'collaborative communities'
Creation of these groups of manufacturers, payers, regulators, patients and health professionals is one of the device center's 2018-2020 strategic priorities.
By David Lim • Sept. 20, 2019 -
Active Implants gets FDA breakthrough status for knee implant
NUsurface is designed for patients who still suffer pain after undergoing a meniscectomy, one of the most widely performed surgical procedures.
By Nick Paul Taylor • Sept. 20, 2019 -
Jacob Bell / BioPharma Dive
FDA moves to end need for predicate comparisons in some 510(k)s
Draft guidance documents detail how four types of medical devices can come to market via the newly minted Safety and Performance Based Pathway rather than through the conventional approach.
By Nick Paul Taylor • Sept. 20, 2019 -
Senate lawmakers direct CMS to boost non-opioid device reimbursement
The medical device industry is seeking congressional support to force Medicare to increase payment after CMS rejected the idea in a hospital outpatient rule proposed in August.
By David Lim • Sept. 19, 2019 -
FDA creates agencywide tech modernization roadmap
The agency plans to spend the next one to two years upgrading its infrastructure to meet emerging data handling needs.
By Nick Paul Taylor • Sept. 19, 2019 -
UK shares 'responsible person' advice as no-deal Brexit looms
The update comes against a backdrop of rising concerns that Britain will leave the European Union without a deal.
By Nick Paul Taylor • Sept. 19, 2019
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