The United States Food and Drug Administration Medical Devices

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

Managing the Cybersecurity Risks of the Medical Internet of Things

The cybersecurity ramifications of the Internet of Things (IoT) are perhaps nowhere more crucial—potentially a matter of life and death, in fact—than in the realm of medical devices. Until recent times, a potential hack of...more

FDA Issues Draft Guidance on ‘Emerging Signals’

New guidance could present liability concerns for device manufacturers. On December 31, 2015, the Food and Drug Administration (FDA or Agency) issued a Draft Guidance for Industry titled “Public Notification of Emerging...more

Blog: Senator Calls on Med Device Leaders to Improve Cybersecurity

Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in...more

Blog: FDA Issues Draft Guidance on Medical Device Cybersecurity

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers...more

Pecking A Blow For Chicken Preemption

It may have been our limited caffeine intake to that point in the day, but, when Bexis asked us to do a post on a case about representations about chicken, our initial thought was of some of the songs sung a la chicken. When...more

FDA Regulatory and Compliance Monthly Recap — January 2016

OPDP enforcement reaches record low in 2015 as drugmakers face uncertainty in digital marketing - Enforcement by the OPDP has fallen notably since 2010. The decline has been attributed, in part, to the agency's slow...more

Postmarket Cybersecurity Recommendations for Medical Devices Issued by the FDA

We’ve blogged about medical device cybersecurity topics. The topic is in the news yet again with the FDA issuing a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity...more

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details...more

FDA Recommends Medical Device Manufacturers Implement a Comprehensive Cybersecurity Risk Management Program in Accordance with...

Medical devices increasingly contain software or connect to networks that may leave the devices vulnerable to cyber-attacks. The U.S. Food and Drug Administration (“FDA”) has recognized the potential risks that these...more

FDA's Expanding Views on Cybersecurity and Medical Devices: Draft Guidance on Postmarket Management of Cybersecurity

Medical device manufacturers need to consider cybersecurity controls in all aspects of the product development process, from conception through commercialization. In response to concerns about increased cybersecurity...more

FDA Releases Draft Guidance for Medical Device Cybersecurity

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called...more

FDA Approves the First Insulin Pump and Glucose Monitoring System for Children

West Chester, Pennsylvania-based Animas Corporation recently announced FDA approval for the use of the Animas®Vibe® Insulin Pump and Continuous Glucose Monitoring (CGM) System for children and adolescents, ages two to...more

Food And Drug Administration Issues Draft Guidance On Cybersecurity In Medical Devices

On January 22, 2016, the Food and Drug Administration (“FDA”) released draft guidance regarding postmarket management of cybersecurity risks in medial devices. This guidance comes over a year after the FDA issued similar...more

Washington Healthcare Update

This Week: Because of the Blizzard of 2016—also known as “Snowzilla”—in Washington, D.C., and other parts of the East Coast, this is a combined issue... The House of Representatives opted not to come back to town until next...more

FDA applies postmarketing requirements to evolving medical device cyber-risks – key messages to manufacturers

With incursions on cybersecurity occurring daily across a variety of platforms, cybersecurity risks are top of mind for FDA and for the device industry....more

Recalled Brainlab Digital Neurosurgery Device Could Pose Serious Injury, Death to Patients

A medical device created by Brainlab and marketed as easy-to-use, intuitive, precise and tailored to surgeons’ needs has been recalled by the U.S. Food and Drug Administration. Cranial-navigation systems sold by...more

Medtronic Launches FDA-Cleared OsteoCool RF Ablation System

According to Medtronic, the OsteoCool RF Ablation System has received U.S. Food and Drug Administration (FDA) 510(k) clearance and they are launching the device in the United States. However, this news may not be...more

Cybersecurity In Postmarket Medical Devices: New Guidance From The FDA

On January 22, 2016, the U.S. Food and Drug Administration ("FDA") issued draft guidance for the medical device industry. The guidance outlines the steps medical device manufacturers should take to monitor, identify, and...more

The FDA’s Draft Guidance on Cybersecurity for Networked Medical Devices

Yet another regulator has weighed in on cybersecurity issues, adding to an already complicated and daunting mosaic of regulatory enforcement actions and guidance. Last week, the U.S. Food and Drug Administration (“FDA”)...more

FDA-regulated industries: Plan now for these changes in 2016

In our last post, Life Sciences Decoded took a look at new food industry regulations that will roll out in 2016 under the FDA’s Food Safety and Modernization Act. But it’s not just the food industry that will need to prepare...more

FDA Proposes Public Notification of “Emerging Signals”

The Food and Drug Administration has proposed a new policy for earlier public notification of medical device safety issues. These notifications will be in addition to the recall notices, safety communications, and press...more

Cybersecurity of Postmarket Medical Devices Addressed by FDA in Draft Guidance

If you read one thing... - FDA released Draft Guidance outlining steps for medical device manufacturers to ensure cybersecurity of medical devices already on the market; comments are due by April 21, 2016. -...more

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more

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