Manufacturers The United States Food and Drug Administration

News & Analysis as of

FDA launches medical device database: AccessGUDID

On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,” or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and...more

Tenth Circuit affirms federal preemption of state law tort claims for medical devices

In Caplinger v. Medtronic, __ F.3d __ (10th Cir. 2015), the Tenth Circuit Court of Appeals affirmed dismissal of a patient’s state law tort claims against a medical device manufacturer as preempted by federal law. The Tenth...more

Weird "Science" = Preemption

Here at the DDL Blog, we write from time to time on food litigation. You might think it’s out of left field, and sometimes we even justify our food posts by pointing out that the “F” in FDCA stands for “Food.” But we need...more

Are Cosmetics Gaining Higher Congressional and FDA Scrutiny?

Currently, FDA regulates cosmetics to ensure they are not adulterated or misbranded, but does not have the authority to order cosmetic recalls or require adverse event reporting. Senators Dianne Feinstein (D-CA) and Susan...more

Bipartisan Senate Bill Would Introduce Largest Increase in FDA Oversight of Personal Care Products—Including Cosmetics—in over 70...

Personal care products, which include cosmetics, are a large, profitable, growth industry. In the United States, cosmetics are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug & Cosmetic...more

Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements [Video]

The FDA provides oversight of dietary supplements. Recently, the New York Attorney General's Office sent cease and desist letters to four major national retailers accusing them of selling dietary supplements that failed to...more

FDA Issues New Rules for Testing of Reusable Medical Devices

The U.S. Food and Drug Administration (FDA) recently announced its tougher new requirements for testing reusable medical devices. ...more

What’s Really in Your Supplements?

New York State Attorney General’s Investigation Has Sparked a Coalition of State Attorneys General Against Herbal Supplement Manufacturers: What does this mean for the industry as a whole in terms of product liability...more

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Long-tail Risk on the Horizon for the Tanning Bed Industry

As the United States continues through a winter that included a historic blizzard in the Northeast, many of us may be longing for summer days spent on the beach, soaking up the sun and working on a tan. A number of people,...more

Some Ideas About 3D Printing

The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators. We’ve given you the link, but it might be behind a paywall. The article indicates...more

Patterson Companies Lead the Charge to Secure Dental Supply Chain

On January 14, 2015, Patterson Companies, LLC, announced that it is formalizing its efforts to shore up its supply chain integrity for its dental customers. The program will assure that dental products that Patterson Dental...more

Product labeling requirements aren't all black and white

Your company has created and developed a new, innovative product. You’ve tested your product, you’ve adopted a new trademark, and you’re ready to begin manufacturing. The remaining steps of preparing your product for sale,...more

Food and Beverage News and Trends

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Congress compromises on school lunch changes. Congress reached a...more

New FDA Cybersecurity Guidance for Medical Device Manufacturers

Last month, the U.S. Food and Drug Administration issued its final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Those guidelines make non-binding recommendations on the...more

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

FDA Issues Cybersecurity Guidelines - Manufacturers of Medical Devices Encouraged to Develop Cybersecurity Controls

The Food and Drug Administration (FDA) issued guidelines this month recommending that manufacturers develop a set of cybersecurity controls in the design of medical devices capable of connecting to the Internet, a network, or...more

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more

Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

FDA Takes a Bold Step Toward Laboratory Developed Test Regulation: How Labs and IVD Manufacturers Should Prepare for the Future

On July 31, 2014, the U.S. Food and Drug Administration ("FDA") announced plans to regulate laboratory developed tests ("LDTs"). In this Client Alert, we explore FDA's proposed regulatory framework for LDTs and discuss some...more

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

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