News & Analysis as of

Manufacturers 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

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

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 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

FDA finalizes 3D printing guidance

by Hogan Lovells on

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive Manufactured Devices”. Please see full Publication below for...more

EDNY Rejects Successor Liability in Hip Implant Case

by Reed Smith on

Happy birthday, Christopher Plummer. The great Canadian actor turns 88 today, and seems as vibrant as ever. What a marvelous career Plummer has had. He is a preeminent Shakespearean actor. We saw him play Iago to James...more

FDA Provides Guidance on 3D-Printed Medical Device Products

by Knobbe Martens on

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more

Guest post – Observations on FDA 3D Printing Guidance

by Reed Smith on

A lot has happened over the past 19 months, some good, some bad, and some just unbelievable. To name a few, and without sounding like a remake of We Didn’t’ Start the Fire, a total solar eclipse, a new human organ was...more

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

by Reed Smith on

The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration...more

Medical Device Security: FDA Releases Final Guidance On Interoperable Medical Devices

by Reed Smith on

On September 6, 2017, the FDA issued its final guidance on “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices.” This Guidance is intended to address the tension between...more

Australia aligns with the European medical device regulatory framework

by Dentons on

In July 2017, the TGA sought comments from interested parties to further align Australian and European medical device regulatory requirements to - - up-classify surgical mesh from Class IIb (medium to high risk) to...more

FDA Sets the Stage for Cures Act Breakthrough Devices Program in Highly Anticipated Guidance Document

by Reed Smith on

On October 25, 2017, FDA released a critical draft guidance on the breakthrough medical device pathway established by the 21st Century Cures Act (the “Cures Act”). The Draft Guidance For Industry, Breakthrough Device Pathway...more

Medical Device Update: FDA Releases Device Change Final Guidances and Breakthrough Devices Draft Guidance, Qualifies First Device...

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) took a number of steps to “advance medical device innovation and help patients gain faster access to beneficial technologies,” as characterized by FDA...more

Product Liability Update: October 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

New California Law Limits Drug Manufacturer Co-Pay Cards and Other Discounts in California

by Hogan Lovells on

In the most recent salvo by states eager to show an effort to contain prescription drug costs, California's governor has signed into law a bill that will prohibit, with some limited exceptions, pharmaceutical manufacturers...more

CDRH's "Critical to Quality" PMA pilot program opens to applicants

by Hogan Lovells on

The voluntary PMA pilot program will run from September 29, 2017, to December 31, 2018, or until a total of nine PMA applicants have been enrolled. The program will engage these PMA applicants to identify and define device...more

N.Y. Court Holds that Manufacturer Cannot be Responsible for Medical Malpractice

by Reed Smith on

We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket (thank you medmal damage cap statutes). We’ve said before that both Levine and Riegel...more

Netherlands Adopts US FDA-based UDI System for Medical Devices

by Knobbe Martens on

A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and...more

The life sciences industry under the antitrust spotlight in China: two practical points

by Hogan Lovells on

The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more

FDA Finalizes Guidance on Interoperable Medical Devices

by McGuireWoods LLP on

Recently, the U.S. Food and Drug Administration (FDA) finalized guidance summarizing its recommendations for interoperable medical devices, or devices that are connected to each other and to other technology. Noting the...more

FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices

by Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more

FDA Issues Guidance on Hurricane Readiness for Medical Devices

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more

OIG’s Expanded Interpretation of Warranty Safe Harbor Portends Well for Value-Based Health Care

by Ropes & Gray LLP on

In a new advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) clarified the scope of the Anti-Kickback Statute (“AKS”) warranty safe harbor (the “Warranty Safe Harbor”). In...more

Is Your Medical Device Software Compliant with the New EU Standards?

by Miles & Stockbridge P.C. on

The IEC 62304 standard specifies life cycle requirements for the development of medical software and software within medical devices. It is a standard that is harmonized between the European Union (EU) and the United States...more

Substantial Changes to South Africa’s Medical Device Regulations Have Far-Reaching Impacts

by Hogan Lovells on

Although medicines have always been heavily regulated in South Africa, medical devices have not. Recently, however, Medical Device Regulations have been issued to bring medical devices into the regulatory fold. Medical...more

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