Policy & Regulation
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Virtual, augmented reality in medicine pique FDA's interest
The agency scheduled a March meeting that will bring together regulators, researchers, big tech and health startups as it looks to better evaluate extended reality medical products.
By Nick Paul Taylor • Jan. 17, 2020 -
ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations
A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.
By Nick Paul Taylor • Jan. 15, 2020 -
Enrollment has ended in Essure postmarket study, FDA says
Bayer discontinued sales of the permanent birth control implant more than a year ago but continues to study its safety profile, as directed by the agency.
By Susan Kelly • Jan. 13, 2020 -
Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound
FDA's device center issued just nine warning letters in the most recent fiscal year, down from 81 in 2015. But with a major reorganization complete, regulators say they can respond to compliance issues more quickly.
By David Lim • Jan. 10, 2020 -
MedTech Europe pushes urgent action to keep devices on sale after MDR
The trade group wants the EU to fix perceived problems with the grace period to allow devices to stay on the market and be reviewed by an MDR-designated notified body.
By Nick Paul Taylor • Jan. 09, 2020 -
FDA sets March meeting to talk future data strategy
Building on the Technology Modernization Action Plan released last year, the agency said it will engage experts on data quality, stewardship, exchange and analytics.
By Nick Paul Taylor • Jan. 08, 2020 -
EU group offers guidance on meeting MDR's cybersecurity standards
The document says it's important to reference the International Medical Device Regulators Forum's cybersecurity guidance, and policies like the General Data Protection Regulation and the EU Cybersecurity Act "might apply in parallel."
By Susan Kelly • Jan. 07, 2020 -
Latest FDA clinical decision support software draft a step forward, industry says
The American Medical Association wrote the guide could "lead to the proliferation of CDS tools for 'non-serious conditions' that are faulty, inaccurate, and without validation, potentially leading to patient harm."
By David Lim • Jan. 07, 2020 -
Industry, doctors, patients diverge on FDA outline for breast implant labels
The Medical Device Manufacturers Association took issue with inclusion of the term "breast implant illness" and called a proposal that manufacturers continually update risk info "impracticable."
By Maria Rachal • Jan. 06, 2020 -
Providers embrace loosening Stark Law regulations, suggest feds could go further
The Trump administration's proposed relaxation of regulations around the physician self-referral law has nearly unanimous support in both the hospital and physician community.
By Ron Shinkman • Jan. 06, 2020 -
CMS delays clinical lab fee schedule data reporting, cuts capped at 15% for 2021
The decision to maintain the status quo comes despite labs hoping the agency would freeze rate cuts next year.
By David Lim • Jan. 03, 2020 -
Notified bodies MedCert, BSI gain new EU MDR and IVDR designations
The European Commission's latest nods bring total notified bodies designated for the Medical Device Regulation to nine and for the In Vitro Diagnostic Regulation to three.
By Nick Paul Taylor • Dec. 31, 2020 -
FDA creates best practices for combination product developers
The 21st Century Cures Act requires the agency to provide final guidance on aspects of the submission process including how companies should obtain feedback.
By Nick Paul Taylor • Dec. 24, 2019 -
Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels
The public meetings in some cases instigated voluntary recalls and led to required market removals. Nearly all called for further research or more robust medical device monitoring.
By Maria Rachal • Dec. 23, 2019 -
Medical device tax disappears, capping decade of industry lobbying
President Donald Trump signed a spending package into law Friday, permanently repealing the ACA tax. The device industry garnered bipartisan backing to nix the 2.3% levy.
By David Lim • UPDATED: Dec. 23, 2019 at 10:18 a.m. -
FTC seeks to block Illumina's $1.2B PacBio acquisition over monopoly concerns
Illumina announced Wednesday it will extend the end time of its merger plan with PacBio to March 31, 2020.
By David Lim • UPDATED: Dec. 19, 2019 at 9:24 a.m. -
CMS wants to overhaul how organs are procured in the US
The agency estimates if all procurement groups met both the new donation and transplantation rate measures, the number of yearly transplants would shoot up more than 15% by 2026.
By Rebecca Pifer • Dec. 17, 2019 -
Medical device, insurance and Cadillac taxes repealed in year-end spending bill draft
If enacted into the law as expected, it's a victory for AdvaMed in a years-long battle to scrap the 2.3% levy initially established to help fund coverage under the Affordable Care Act.
By David Lim • Dec. 17, 2019 -
EU Parliament finalizes 4-year MDR delay for some Class I devices
The delay will help slightly reduce the crush of products needing notified body review by May 26, 2020.
By David Lim • UPDATED: Dec. 17, 2019 at 12:38 p.m. -
Tandem wins FDA go-ahead for 1st interoperable, automated insulin dosing software
The clearance of Tandem's Control-IQ algorithm is part of a broader regulatory vision for people with diabetes to have the freedom to pair their preferred glucose sensing and insulin delivery devices.
By Maria Rachal • Dec. 16, 2019 -
Boston Scientific gets 1st US disposable duodenoscope clearance
SVP of Endoscopy Art Butcher told investors last June the single-use duodenoscope could represent more than a $1 billion market opportunity.
By David Lim • Dec. 16, 2019 -
Hahn confirmed as next FDA commissioner in 72-18 Senate vote
Stephen Hahn's swift confirmation won applause from lawmakers, former FDA commissioners and industry groups.
By David Lim • Dec. 12, 2019 -
EC medical device group sheds new light on MDR, IVDR sampling codes
The Medical Device Coordination Group also issued a guidance explaining codes used to define the scope of a notified body's designation.
By Nick Paul Taylor • Dec. 12, 2019 -
Grassley, Warren press FDA to issue over-the-counter hearing aid regulations
The agency missed its estimate that the rules would come out last month, but a spokesperson said that timeline was "not intended to be a precise estimate."
By David Lim • Dec. 09, 2019 -
House bill would speed CMS coverage for breakthrough medtech
The bipartisan legislation, reintroduced on Friday, promises faster access to new medical technologies by requiring Medicare to cover devices approved through FDA's breakthrough pathway during a three-year transitional period.
By Susan Kelly • Dec. 09, 2019
