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Device makers must verify third-party lab data, FDA warns

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a letter warning medical device manufacturers and sponsors of device studies to carefully evaluate the third parties that they engage to conduct performance...more

FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s

Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more

FDA broadens scope on communication about unapproved uses to HCPs

The U.S. Food and Drug Administration (FDA) published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more

FDA fills 510(k) guidance gaps with drafts on predicate devices, clinical data, implantables

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products that can be found...more

Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

Helping companies navigate the COVID-19 pandemic

Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on nearly 200 matters, ranging from...more

FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment

The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications...more

FDA releases four final guidances on the 510(k) program; Special 510(k) guidance confirms new approach to eligibility and broader...

On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program. ...more

Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final...

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...more

FDA details recommendations for live case presentations during medical device clinical trials in final guidance

This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more

An intelligent approach for regulating medical device AI

From analysis of medical imaging such as echocardiograms, computed tomography (CT), endoscopy, and skin photographs, to tissue histology and physiological data such as electrocardiograms (ECG), these technologies have...more

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. ...more

Parsing products: FDA regulatory policy for multi-function medical devices

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more

What device companies need to know ahead of an advisory panel meeting

For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or approval from the FDA. ...more

New FDA Final Guidance on Medical Device Panel Meetings Provides Certain Changes to Timelines and Procedures

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or, panel meetings). The document,...more

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