Medical Devices, FDA | JD Supra Law News

Robotic Surgical Machines: Safe or Deadly?

by The Rothenberg Law Firm LLP on 5/17/2013

Imagine your doctor recommends routine spleen removal surgery. When discussing your surgical options, the doctor tells you about da Vinci® - an increasingly used surgical robot. The doctor raves about the safety,...more

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 5/15/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

by Fuerst Ittleman David & Joseph, PL on 5/10/2013

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

Intuitive Surgical Securities Fraud Investigation and Class Action Lawsuit FAQ

by Wohl & Fruchter LLP on 4/29/2013

Our firm is investigating possible violations of federal securities laws by officers and directors of Intuitive Surgical, Inc. (Intuitive Surgical) (Nasdaq: ISRG). A class action lawsuit has recently been filed against...more

An “App” a Day Will NOT Keep the FDA Away: The Rise of Mobile Medical Applications

by Nicholas Weiss | Sedgwick LLP on 4/26/2013

The number of mobile applications (apps) available to consumers on their iPhones, Androids, and iPads is astonishing. As of January 2013, there were more than 775,000 different apps available to iPhone and iPad users. It...more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

by Matthew A. Reed | Sedgwick LLP on 4/26/2013

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

Update on Transvaginal Mesh Litigation

by Phillips Law Offices on 4/24/2013

We are at the forefront of Chicago law firms representing women injured by surgical mesh, a product used to treat pelvic organ prolapsed (POP) and Stress Urinary Incontinence (SUI). Made of woven polyester, polypropylene or...more

Thoughts on Regulatory Constraints of Business Models

by Seth Mailhot | Sheppard Mullin Richter & Hampton LLP on 4/8/2013

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more

DePuy Owes $8.3M After First Hip Replacement Trial

by Michele Bowman | Lawyers.com on 3/14/2013

A jury in California on Mar. 8 ordered DePuy Orthopaedics to pay over $8.3 million to a man who says the Johnson & Johnson subsidiary knowingly made and marketed a faulty hip replacement device. ...more

Vaginal Mesh Damages Against Johnson & Johnson Exceed $11 Million

by Audet & Partners, LLP on 3/5/2013

The first jury verdict against Johnson and Johnson (J&J)’s Ethicon subsidiary has resulted in a powerful statement regarding the pharmaceutical company’s lack of adequate warnings of the health risks posed by the transvaginal...more

FDA Issues Draft Guidance on Medical Device Recalls - How to Distinguish Recalls from Product Enhancements

by King & Spalding on 3/4/2013

On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the...more

FDA Draft Guidance on Device “Product Enhancements” Could Lead to Increased Recalls

by Ropes & Gray LLP on 2/27/2013

On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance...more

FDA Issues Supplemental Notice of Proposed Rulemaking and Draft Guidance Regarding Inclusion of Pediatric Subpopulation...

by King & Spalding on 2/27/2013

On February 19, 2013, FDA issued a supplemental notice of proposed rulemaking in the Federal Register, re-proposing amendments regarding information about pediatric subpopulations that must be submitted for certain medical...more

CMS Issues Final Rule for Implementing Sunshine Act

by Wilson Sonsini Goodrich & Rosati on 2/14/2013

On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

When Medical Devices Kill or Injure

by Lanier Law Group, P.A. on 2/1/2013

Ventlab Corporation, based in Mocksville, NC, issued a recall over the summer for a number of manual resuscitator devices. The devices are designed to help patients who cannot breathe on their own. According to the FDA, a...more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

by Erin M. Bosman, Julie Y. Park, Joanna Simon | Morrison & Foerster LLP on 1/15/2013

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

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Medical Devices › The United States Food and Drug Administration

Robotic Surgical Machines: Safe or Deadly?

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

Intuitive Surgical Securities Fraud Investigation and Class Action Lawsuit FAQ

An “App” a Day Will NOT Keep the FDA Away: The Rise of Mobile Medical Applications

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

Update on Transvaginal Mesh Litigation

Thoughts on Regulatory Constraints of Business Models

DePuy Owes $8.3M After First Hip Replacement Trial

Vaginal Mesh Damages Against Johnson & Johnson Exceed $11 Million

FDA Issues Draft Guidance on Medical Device Recalls - How to Distinguish Recalls from Product Enhancements

FDA Draft Guidance on Device “Product Enhancements” Could Lead to Increased Recalls

FDA Issues Supplemental Notice of Proposed Rulemaking and Draft Guidance Regarding Inclusion of Pediatric Subpopulation...

CMS Issues Final Rule for Implementing Sunshine Act

When Medical Devices Kill or Injure

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Digital Health: Where is the Action for Entrepreneurs? [Video]

FDA Announces Public Meeting to Discuss Standardization and Availability of Medical Device Labeling

FDA Issues Final Guidance Documents on FDA’s eCopy Program for Medical Device Submissions

FDA Issues New Guidances Regarding Its Preliminary Review of 510(k) Notices and PMA Applications

FDA Issues Final Guidance on Filing PMAs and 510(k)s

Excise Tax Kicks In Jan. 1 On Certain Medical Devices

Foley Hoag and AdvaMed Collaborate on Industry Guidance on Retail Exemption in Final Device Tax Regulations

Medical Device Law Update - December 2012: FDA and Industry Form “Consortium” to Improve Device Approval Process

IRS Releases Final Rule on Medical Device Tax

Digital Health: Where is the Action for Entrepreneurs? [Video]

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