News & Analysis as of

Medical Devices

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by DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. FDA publishes guidance for menu-labeling rule. On November 7, the FDA published...more

UK publishes paper on Brexit and medicines regulation

by Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

FDA Finalizes De Novo Evaluation Guidance and Issues Associated Refuse to Accept Checklist

by Hogan Lovells on

On October 30, 2017, the Food and Drug Administration (FDA or the Agency) released its final De Novo request guidance document entitled, De Novo Classification Process (Evaluation of Automatic Class III Designation) (Final...more

C.D. Cal. Excludes Three Plaintiff Experts in Breast Implant Case

by Reed Smith on

It is not as if we are delighted to see efforts to resuscitate breast implant litigation, but we won’t groan when the rulings are as good as they are in Laux v. Mentor Worldwide, LLC, No. 2:16-cv-01026-ODW(AGR) (C.D. Cal....more

FDA Issues Guidance on Submitting 510(k)s for Changes to Existing Devices

by Arnall Golden Gregory LLP on

On October 25, 2017, the Food and Drug Administration (FDA) issued a final guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, which describes when a change in a medical device would...more

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices

by Reed Smith on

FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information...more

FDA Issues Final Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. The guidance is far reaching...more

FDA Issues Draft Guidance on Breakthrough Devices Program

The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more

Recent FDA Steps to Advance Medical Device Access and Innovation

by K&L Gates LLP on

On November 6, 2017, U.S. Food and Drug Administration (“FDA” or “the Agency”) Commissioner Dr. Scott Gottlieb reiterated the Agency’s commitment to advancing medical device access and innovation by stating, “[o]ur goal is to...more

Sudan Now Open For Business, But Risks Remain

On October 12, 2017, the United States made permanent its lifting of a longtime general embargo on trade and investment with Sudan. As a result, U.S. individuals and companies are now generally free to engage in transactions...more

Digital Health Report - Fall 2017

Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...more

Clinical trials Part II: Privacy, cybersecurity risks, and managing ePHI

by Thompson Coburn LLP on

The ongoing digitization of the drug and medical device industries continues, and, as a result, new considerations have come to the forefront for companies engaged in clinical trials. In Part 1 of this series, we described a...more

Petitioners Must Explain Combining Multiple Embodiments of Reference in Obviousness Argument

by Jones Day on

In a series of recent decisions, the PTAB denied institution on a dozen petitions on related patents because of one problem it identified in the petitioner’s arguments. All of the petitioner’s proposed grounds challenged the...more

FDA Issues Long-Awaited Final Guidance on When a Device Modification Requires a New 510(k)

by Hogan Lovells on

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission of a new 510(k) notice, the U.S. Food and Drug Administration (FDA or the...more

China FDA’s Device Regulations Ready for Public Comments

by Ropes & Gray LLP on

The China Food and Drug Administration (CFDA) has published its proposed amendment of the Medical Device Regulations (MDR), previously known as the State Council Order # 650, for public comments. This Alert summarizes the key...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

FDA Issues Guidance on Drug and Device Classifications

by Arnall Golden Gregory LLP on

On September 26, 2017, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled Classification of Products as Drugs and Devices & Additional Product Classification Issues to clarify FDA’s...more

Second Circuit Affirms Exclusion of Plaintiffs’ Experts – and Summary Judgment for Defendant – in Mirena MDL

by Reed Smith on

As we write this, our fair city remains in a blissful haze following our Eagles’ 33-10 rout of the 49’ers to go 7-1 in the NFC East, so it might be appropriate to call today’s opinion a “touchdown.” On the other hand, the...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Majority Leader Kevin McCarthy (R-Calif.) said lawmakers will vote this week on legislation to renew federal funding for the Children’s Health Insurance Program (CHIP), even amid unresolved partisan disagreements over...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

Bad For Your Health: Lawsuit Advertising Implications And Solutions

by Shook, Hardy & Bacon L.L.P. on

Shook, Hardy & Bacon Partner Cary Silverman has authored a report for the U.S. Chamber Institute for Legal Reform examining the effects of advertising soliciting plaintiffs for lawsuits targeting prescription drugs and...more

OIG Wants CMS to Track Medicare Costs from Device Failures

by Reed Smith on

A recent Office of Inspector General (OIG) report suggests that the lack of medical device-specific information on Medicare claim forms complicates CMS efforts to identify and track Medicare costs related to the replacement...more

Three Strikes And . . . You Get Another Chance?

by Reed Smith on

“Legal conclusions, though, are not entitled to the assumption of truth.” If that were the only point we could take away from Wright v. Howmedica Osteonics Corp., No. 5:17-cv-459, 2017 U.S. Dist. LEXIS 168785 (M.D. Fla. Oct....more

As medical costs climb, it’s not just drip, drip waste, look at hospital bloat, too

Whether it happens in the drip, drip, drip of costly eye drops or it occurs in the flash of a pricey imaging scan, patients get gouged by modern medicine’s wasteful practices. The inefficiencies can be traced to many and...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

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