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Medical Devices › Medical Device Accessories

Snell & Wilmer

Ninth Circuit Upholds Felony Conviction of Urologist, Under FDCA, for Reusing Single-Use Needle Guides During Prostate Biopsies...

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In 2014, Las Vegas urologist, Dr. Michael Kaplan, was convicted by a federal jury for reusing single-use plastic needle guides during prostate biopsies. He was convicted of conspiracy to commit adulteration in violation of...more

K&L Gates LLP

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

K&L Gates LLP on

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

Knobbe Martens

FDA Issues Guidances for Medical Device-Related Apps and Systems

Knobbe Martens on

The U.S. Food and Drug Administration (“FDA”) recently issued guidance on an array of medical device-related software and systems. A first guidance for ”Data Systems and Imaging Devices” issued on February 9, 2015, and...more

Stinson LLP

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Stinson LLP on

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate.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

Sheppard Mullin Richter & Hampton LLP

Go For De Novo: FDA’s Revised Approach to Medical Device Accessories

Sheppard Mullin Richter & Hampton LLP on

Accessories are an everyday reality for almost all users of technology products today.  They can help improve efficacy, increase usability and make many other improvements to the technology we use.  Increasingly, accessories...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?

Sheppard Mullin Richter & Hampton LLP on

On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that...more

Sheppard Mullin Richter & Hampton LLP

Interface without Regulation – FDA Deregulates MDDS and Related Technologies

Sheppard Mullin Richter & Hampton LLP on

2015 has been a busy year for the Food and Drug Administration (FDA). In January, the FDA issued guidance documents addressing wellness applications as well as accessories to medical devices and it looks like the...more

McDermott Will & Emery

FDA Will Not Enforce Regulatory Controls for Medical Device Data Systems and Two Other Health IT Devices

McDermott Will & Emery on

In a move certain to please developers of health information technology (IT) products, on February 6, 2015, the U.S. Food and Drug Administration (FDA) posted final guidance announcing its intent to exercise enforcement...more

King & Spalding

FDA Issues Draft Guidance That Affects Health IT

King & Spalding on

The U.S. Food and Drug Administration (“FDA”) recently issued draft guidance that directly affects health information technology (“Health IT”), specifically medical device accessories and general wellness products. The new...more

King & Spalding

FDA Issues Draft Guidance on Medical Device Accessories

King & Spalding on

On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015)...more

McDermott Will & Emery

FDA Issues Draft Guidance on General Wellness Devices and on Medical Device Accessories

McDermott Will & Emery on

On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA’s proposed approach to the regulation of general wellness devices (Draft General Wellness Guidance) under the...more

Morrison & Foerster LLP

FDA Policy On Wellness Products Is Healthy For Industry

Morrison & Foerster LLP on

On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more

Morgan Lewis

Medical Device Update: FDA Releases General Wellness Products and Device Accessories Guidance Documents

Morgan Lewis on

Background - On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more

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