FDA pitches shorter grace period for UDI revision

The agency wants information submitted to the UDI database to be available to public users within one week, cutting back the 30 days companies have been given to edit their submissions for the last four years.

By Maria Rachal • Dec. 20, 2018

Information blocking rule blows past deadline

"Patients and providers have looked on with disappointment" at the delay, Health IT Now Executive Director Joel White said.

By Rebecca Pifer Parduhn • Dec. 18, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

FDA outlines fast track vision for breakthrough devices

The agency also announced plans to establish a pathway for devices aimed at treating non-life-threatening diseases not eligible for the original program.

By David Lim • Dec. 18, 2018

FDA addresses manufacturing site changes in final guidance

The agency issued final guidance detailing when a medical device maker that plans a change in manufacturing site should submit a premarket approval application supplement.

By Susan Kelly • Dec. 17, 2018

FDA draft guidance aims to clarify X-ray radiation rules

The agency also said it plans to harmonize its performance standards with those of the International Electrotechnical Commission to simplify compliance for global manufacturers.

By Susan Kelly • Dec. 17, 2018

Texas judge rules ACA unconstitutional

The end of the Affordable Care Act would kill the medical device tax, but the ruling will almost certainly be appealed to a higher court.

By Tony Abraham • Dec. 14, 2018

FDA: Benefits beat risks with unregulated medical software

The agency reviewed safety and best practices for technologies like e-prescribing tools and mobile wellness apps, building on prior 21st Century Cures guidances addressing software as a medical device.

By Maria Rachal • Dec. 14, 2018

FDA walks back new device class definitions after industry blowback

AdvaMed and the Medical Device Manufacturers Association scored a temporary win after arguing the proposed revisions to the Class III definition could shift more devices into the high-risk category.

By David Lim • Dec. 14, 2018

Medtech industry cheers as NAFTA 2.0 edges forward

Trade groups heralded improved transparency in the recently-signed USMCA, which includes a provision that would enforce more timely reimbursement decision-making by national bodies.

By Nick Paul Taylor • Dec. 14, 2018

FDA touts progress in move toward global device audits

Participating manufacturing sites have spiked this year with 2,629 cumulatively added as of the third quarter of 2018, up from 777 at the end of 2017. 

By David Lim • Dec. 13, 2018

FDA adds information on device BLAs to user fee guidance

The revised document features additional information on the fees for device biologics license applications.

By Nick Paul Taylor • Dec. 13, 2018

FDA rates GE ventilator safety guard recall as Class I event

The recall was triggered after the tech giant discovered the device has the potential to disconnect from the patient's breathing circuit.

By Nick Paul Taylor • Dec. 13, 2018

Apple EKG, artificial iris among FDA 2018 device decisions

De Novos are on the rise, but both premarket approvals and 510(k)s appear to be slightly down from 2017, according to nearly year-end data from FDA.

By Meg Bryant • Dec. 12, 2018

Australia plans reclassification of medical software to better reflect risk

The country's regulator thinks the current system underestimates the threat posed by software as a medical device.

By Nick Paul Taylor • Dec. 12, 2018

Lawmakers impatient for ONC interoperability rule

"It is hard to explain to people that Congress provided the tools necessary for doctors and patients to better coordinate their care through the sharing of patient data, but nothing has changed," Rep. Michael Burgess, R-Texas, said at a House health subcommittee hearing.

By Rebecca Pifer Parduhn • Dec. 11, 2018

Thermo Fisher gets FDA nod for plazomicin immunoassay

The antibiotic, marketed as Zemdri, is used to treat patients with complicated urinary tract infections.

By Susan Kelly • Dec. 11, 2018

Duodenoscope studies find higher-than-expected contamination rate, FDA says

Across studies run by Olympus, Fujifilm and Pentax, 6% of sampled devices were contaminated with microorganisms including pathogenic strains such as E. coli.

By Nick Paul Taylor • Dec. 11, 2018

FDA to revisit transvaginal mesh issues at February meeting

The agency said it may consider additional regulatory actions based on public feedback and Feb. 12 advisory panel discussions.

By Susan Kelly • Dec. 10, 2018

Cybersecurity priorities laid out by key House panel

The House Energy and Commerce Committee issued a report outlining six strategies for strengthening the nation's defenses against cybersecurity vulnerabilities with a focus on medical devices in healthcare.

By Susan Kelly • Dec. 10, 2018

FDA guide unveils vision for cancer diagnostics

The proposal came the same day lawmakers released an updated draft bill that would grant FDA authority to oversee in vitro clinical tests, such as test kits and laboratory developed tests.

By David Lim • Dec. 7, 2018

AdvaMed, MITA offer feedback on CDRH guidance priorities

Industry groups backed some of the FDA's device center proposals for fiscal year 2019 and added a few of their own.

By Maria Rachal • Dec. 7, 2018

FDA seeks to boost use of De Novo pathway with proposed rule

The increased clarity intended for the regulatory framework and application process could incentivize manufacturers to establish new predicates, aligning with the agency's plan to phase out older ones.

By Maria Rachal • Dec. 5, 2018

FDA endorses open database for genetic variants

The agency said it hopes the move will encourage database administrators to submit genetic variant information to publicly accessible databases, with the aim of spurring advancements in precision medicine.

By Susan Kelly • Dec. 5, 2018

Bipartisan bill introduced in Senate to penalize Medicaid gaming

The incoming leaders of the Senate Finance Committee want to set monetary penalties for companies that misclassify products within Medicaid.

By Andrew Dunn • Dec. 5, 2018

ACLA appeals lab payment suit to higher court

A watchdog report on Medicare lab payments will not help the industry's case, analysts said.

By David Lim • Dec. 5, 2018