Cost recovery and the future of the medical device regulation program in Canada.
It is a perennial problem that some government programs seemingly have an abundance of financial capacity while others seem chronically under-funded. Over the years, legislators, ministers, and other government officials have tried a variety of methods to address under-funding. One such method was announced by the Treasury Board on...

Prescription remedies.
A broad coalition of deregulators is gearing up to reform the FDA. How far will they go? "The Food and Drug Administration has made American drugs and medical devices the envy of the world," wrote Bill Clinton in his introduction to the March National Performance Review proposal to "reinvent"...

Topical devices for atopic dermatitis: what is the data behind these new products?
The last 5 years have brought a host of new treatments for dermatitis marketed as devices, rather than drugs, to work as stabilizers of the epidermal barrier. Their active ingredients have been tested independently and they are approved through a medical device approval process as 510(k) medical devices. This...

Impregnated dressings: drugs or devices?
Introduction This article outlines the main legal and regulatory aspects concerning the registration and reimbursement of drugs and dressings in caring for the diabetic foot in the UK. When inventing or developing a novel product or treatment, it is essential to understand the regulatory system for both...

Silicone gel-filled breast implants may make a comeback.
A clinical trial testing a new kind of silicone gel breast implant may herald a return to more widespread use of these implants. Currently, their general use is still banned by the US Food and Drug Administration (FDA). They are defined as Class III medical devices, subject...

State lawsuits may proceed against medical device manufacturers.
I. INTRODUCTION II. MEDICAL DEVICE AMENDMENTS III. PREEMPTION IV. FACTS OF LOHR A. District Court B. Eleventh Circuit Court of Appeals C. Supreme Court 1. Negligent Design Claims Under Section 510(k) 2. "Requirement" Under Section 360k(a) 3. Breyer's...

Agency's approval plan flawed.
FDA is considering new guidance that would allow drug companies to use journal articles to promote "potentially dangerous uses" of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform,...

Supreme Court upholds federal pre-emption of state device liability laws.
The U.S. Supreme Court Feb. 20 upheld federal preemption of state liability laws when it comes to lawsuits involving medical devices approved through PMAs. The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation, according...

President Bush proposes about $97 million more for medical product safety, user fees for generics.
FDA is requesting nearly $2.4 billion in the administration's fiscal year 2009 budget--a 5.7% increase over the budget that FDA received for the current fiscal year--the agency announced Feb. 4. The fiscal 2009 request, which covers the period Oct. 1, 2008, through Sept. 30, 2009, includes $1.77...

Mentor's saline breast implants on way to full approval in the USA.
Mentor Corp is on the way to winning full US Food and Drug Administration (FDA) approval for its saline-filled breast implants. The FDA's Medical Devices Advisory Committee recommended in early March the approval, with conditions, of the company's premarket approval (PMA) application. The vote was seven to...