Policy & Regulation
-
Hospitals, manufacturers could donate cybersecurity software under proposed regs
With the cost of protecting systems from malicious hackers increasing, the idea to tweak the anti-kickback laws recognizes some physician practices don't have the resources or expertise to keep pace, one lawyer told MedTech Dive.
By David Lim • Oct. 14, 2019 -
Medical software makers get new guidance on MDR, IVDR
The European Commission's Medical Device Coordination Group aims to clarify which software will be subject to the new regulations, and how those products should be classified and placed on the market.
By Dana Elfin • Oct. 14, 2019 -
FDA clears first rapid Ebola virus diagnostic
Risk of flare up remains, but the United Nations called the outbreak responsible for killing 2,100 people over 14 months in the Democratic Republic of the Congo "significantly contained."
By Nick Paul Taylor • Oct. 11, 2019 -
GAO finds low uptake of disposable wound care devices
Advocates of the products, sold by companies including Acelity and Smith & Nephew, argue the size and cost make them preferable to durable devices when treating small wounds.
By Nick Paul Taylor • Oct. 11, 2019 -
CDS software, labels for staplers and breast implants among FDA 2020 guidance priorities
The annual publication comes days after the White House issued an executive order aimed at limiting agency use of the documents.
By David Lim • Oct. 11, 2019 -
HHS hesitant to include implantable medical devices in Anti-Kickback safe harbor
The government appears to be considering various methods to exclude device manufacturers from its care coordination safe harbor while allowing digital health technologies used to remotely monitor patients to take advantage of it.
By David Lim • Oct. 10, 2019 -
Dekra Germany is first notified body designated under IVDR
The designation of the first notified body to review in vitro diagnostics means manufacturers can start working toward certification by the May 2022 deadline.
By Dana Elfin • Oct. 10, 2019 -
FDA makes final recommendations on vascular device labels
The guidance documents address issues such as the risk of coatings separating from devices.
By Nick Paul Taylor • Oct. 10, 2019 -
Experimental cancer IVD trial guidance finalized
AdvaMed won many many of the changes it sought during the comment period, including ones related to communication with the FDA.
By Nick Paul Taylor • Oct. 10, 2019 -
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. 09, 2019 -
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. 07, 2019 -
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. 03, 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. 02, 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. 02, 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 -
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 -
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 -
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 -
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 at 11:01 a.m. -
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 -
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
