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

Administration Releases Spring 2016 Regulatory Agenda with Timeline for Rulemaking

The Obama Administration has posted its updated 2016 regulatory agenda, which lists major pending or planned rulemaking and the expected timing for action. The latest agenda includes numerous rules in the pipeline impacting...more

FDA’S Draft Guidelines for 3D Printing of Medical Devices

On May 10, 2016, the FDA issued a document entitled Technical Considerations for Additive Manufacturing Devices. The document consists of 25 pages of “draft” guidelines that provide the FDA’s “initial thinking on...more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

AGG Food and Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

FDA Releases Draft Guidance for 3D Printed Medical Devices

On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations...more

FDA Outlines Future Medical Device Coordinating Center

The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to...more

Guest Post – Highlights of FDA Draft Guidance on 3D Printing

Another guest post today, this one by Reed Smith’s Matt Jacobson on the draft guidance document released earlier this week by the FDA. With the 3D printing of medical devices at the forefront of the burgeoning additive...more

FDA Draft Guidance Outlines Regulatory Requirements for 3D Printed Medical Devices

On May 10, 2016, FDA released a much-anticipated draft guidance (the “Guidance”) concerning medical devices that incorporate additive manufacturing (AM) technologies, a category which includes 3D printed devices. AM...more

FDA Issues Draft Guidance for 3D Printed Medical Devices

The U.S. Food and Drug Administration (FDA) issued draft guidance for additive manufactured medical devices, more commonly known as 3D printed medical devices, on May 10, 2016. The draft guidance document, available here, is...more

Plaintiff’s Claim that Manufacturer Improperly Trained Physician in use of Class III Medical Device Preempted by Federal Law

In Ashley Glennen v. Allergan, Inc., 2016 Cal. App. LEXIS 347, published April 29, 2016, the California Court of Appeal, First District, affirmed the trial court’s sustaining of a demurrer in a Lap-Band injury case on the...more

When Customer Supply Contracts Lead to Trouble: Exclusive Dealing Provisions Result in FTC Monopolization Action against Invibio

The Federal Trade Commission (FTC) continues to aggressively enforce the antitrust laws. On April 27, 2016, the FTC took action against Victrex, plc and its wholly owned subsidiaries, Invibio, Inc. and Invibio Limited...more

Benesch’s 2nd Annual 3D Printing Seminar (A Summary Repeat)

Several hundred business leaders, engineers, attorneys and academics gathered last week for an annual symposium on 3D Printing hosted by Benesch, Friedlander, Coplan & Aronoff. The ability to form physical objects from...more

Preemption: Oregon Has Not Gone Bananas

Can you get sued over a picture of a banana? It seems the answer might depend on where you live and probably not in Oregon. That is one takeaway from a good preemption case that came out of the District of Oregon last week,...more

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

C.D. Cal. Dismisses Infusion Pump Complaint

The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain. According to the plaintiff, the device...more

FDA Extends Comment Period on Third-Party Medical Device Servicing

As an update to my post on Friday, April 22, FDA has extended the deadline for comments on third-party servicing of medical devices. According to FDA’s notice of extension, comments are now due by June 3, 2016....more

FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation

On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing...more

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

Settle or Fight FDA/DOJ Off-Label Use Allegations? WSJ Editorial Looks at Vascular Solutions Trial Win and Asks What's Next?

In an editorial this weekend entitled “No Justice for Business,” The Wall Street Journal hailed a recent trial win by medical device maker Vascular Solutions, Inc. (VSI) as a “victory for common sense and the First Amendment”...more

FDA Active on the Device Front for Q1 2016

Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more

FDA Medical Device Quality Inspections Drop in 2015

The U.S. Food & Drug Administration (FDA) has released statistics showing that it inspected fewer medical device manufacturers in 2015 than in 2014....more

Life Spine Announces FDA Clearance of PROLIFT Expandable Interbody System

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the PROLIFT Expandable Interbody System of Life Spine. Accordoing to its website, Life Spine is a medical device company based in Huntley, Ill.,...more

Heater-Cooler Devices Linked to Infections

Heater-cooler devices are used during cardiothoracic surgeries, and other medical and surgical procedures to warm or cool a patient. They include water tanks that provide temperature-controlled water to external heat...more

FDA Issues Draft Guidance on Medical Device Interoperability

On January 26, 2016, the FDA offered for public comment its draft guidance on medical devices and interoperability, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices—Draft...more

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