News & Analysis as of

Medical Devices

China FDA Releases Guidance on Acceptance of Foreign Medical Device Study Data

by Ropes & Gray LLP on

On January 10, 2018, the China Food and Drug Administration (“CFDA”) announced the implementation of the Technical Guidelines Governing Acceptance of Medical Device Clinical Data from Foreign Studies (the “2017 Guidelines”)....more

[Webinar] Software as a Medical Device (SaMD): What It Is and How Can We Protect Our Related IP? - January 31st, 10:00am PT

Software as a medical device (SaMD) is a rapidly expanding field, melding pharmaceuticals and digital health, from wearable health trackers to apps capable of diagnosing and treating diseases. Fueling the fire are the recent...more

NDA/ANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book

by Mintz Levin on

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more

Dental Device Class Action Comes Back To Bite Plaintiffs

by Reed Smith on

You don’t see class actions going to trial very often, but that is what happened in Patricia A. Murray Dental Corp. v. Dentsply International, Inc., and the defendant device manufacturer came away with a defense verdict that...more

GDPR promises stringent penalties for noncompliance: Be ready for the May 2018 deadline

by Hogan Lovells on

In 1995, the European Union (EU) sought to improve the security of business data within its member countries by introducing the Data Protection Directive. ...more

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

by Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

Guest Post – No Way For Non-Resident Plaintiffs To “MacGyver” Their Way Into Illinois Court Due To Forum Non Conveniens

by Reed Smith on

Today’s post is another guest post from Kevin Hara, of Reed Smith, who is on his way to becoming a semi-regular blog contributor. This post is about forum non conveniens, which is more discretionary, and less enforceable...more

FDA Releases 2018 Roadmap: Focus On Digital Health Continues

by Kelley Drye & Warren LLP on

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities,...more

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about...more

FDA Presents Webinar on Technical Considerations for Additive Manufactured Medical Devices

by Reed Smith on

On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug...more

No Old Kentucky Home for Parallel FDCA-Based Tort Claims

by Reed Smith on

Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following: "In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the...more

FDA 2017 Year in Review

by McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

The Life Sciences Report - Winter 2018

Life Beyond FDA Clearance or Approval: The Reimbursement Challenge - To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more

Report Finds European Union's Assessment of High-Risk Medical Devices of Low Quality

by Knobbe Martens on

A report appearing in the December 2017 issue of Value in Health, (a journal of the International Society for Pharmacoeconomics and Outcomes Research) concluded that assessments of high-risk medical devices in the European...more

Microbot Medical to Acquire CardioSert's Technology

by Knobbe Martens on

Microbot Medical Inc. announced that it entered into an agreement with CardioSert Ltd. to acquire CardioSert’s patented guidewire technology, including R&D information, technical know-how, and intellectual property....more

New cybersecurity threats with potential to impact health care industry identified

by Bricker & Eckler LLP on

On January 4, 2018, the National Health Information Sharing and Analysis Center (NH-ISAC) posted an announcement regarding the cybersecurity threats Meltdown and Spectre that were recently identified....more

Proposed amendments to Food and Drug Regulations and the Medical Devices Regulations to publicly release clinical data after...

by Smart & Biggar on

Following release of a white paper in March, on December 9, 2017, Health Canada released proposed amendments to the Food and Drug Regulations under which “clinical summaries, reports and supporting data of clinical trials...more

New FDA Guidance Clarifies Exemptions for Digital Health Software

• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more

FDA Guidance on Decision Support Software: Implications for Industry

by Epstein Becker & Green on

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software” (“CDS Guidance”). According to FDA Commissioner Scott Gottlieb, M.D., the CDS...more

Capitol Hill Healthcare Update

by BakerHostetler on

Lawmakers return to Capitol Hill this week ahead of more self-imposed deadlines to resolve a series of thorny healthcare policies, including funding for the Department of Health and Human Services (HHS) and the rest of the...more

Where To Find Our Research 3.0

by Reed Smith on

Happy New Year! - It’s been 3 ½ years since we last updated our index to our online research resources. That’s almost ? of the total life of the blog, which started in way back in 2006. We’ve been blogging now for well...more

The Highs - Celebrating the Ten Best Prescription Drug/Medical Device Decisions of 2017

by Reed Smith on

Ending the year on a high note is one thing that the blog tries to do – with the top ten drug/device product liability decisions of the year. Occasionally, a court will do something that ruins the party, with an eleventh-hour...more

China FDA Solicits Comments on Conditional Approvals for New Drugs and Compassionate Use of Investigational Drugs

by Ropes & Gray LLP on

The China Food and Drug Administration (“CFDA”) recently proposed two draft circulars for public comments, namely (a) the Technical Guidelines for Conditional Approvals for Urgently Needed Drugs (“Draft Conditional Approvals...more

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

The Case of the Double-Dipping, Creative-Editing Plaintiff

by Reed Smith on

This week saw the birthdays of two folks who were sort of prominent in our youth. First, Uri Geller, the Israeli ‘psychic’, turned 71. He showed up on our tv constantly in the 1970s and 80s, bending spoons with his mind. ...more

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