USA -
Will a new FDA user fee discourage innovation in medical devices ?

More medical device companies have been using an alternative pathway to get innovative products on the market faster, but a new user fee on industry could affect the use of this pathway.

The “de novo” classification pathway has been used to get devices on the U.S. market such as Accelerate Diagnostics Inc.'s PhenoTest BC Kit, the first test to identify organisms that cause bloodstream infections and provide information on the correct antibiotics for treatment. De novo is a way to get products on the market without going through the Food and Drug Administration’s most stringent review process, known as premarket approval.

However, if companies have to pay a new fee that is seen as relatively burdensome, it could dissuade applicants from seeking de novo classification...

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USA -
Medtronic Settles Deceptive Advertising Lawsuit for $12M

State attorneys general in Massachusetts, Oregon, California, Illinois and Washington on Wednesday announced a $12 million multi-state settlement with Medtronic to resolve claims the company deceptively marketed one of its devices known as Infuse. The complaint alleged that Medtronic used deceptive company-sponsored scientific literature to convey false and misleading claims about the device’s safety, comparative efficacy and superiority to expand its market. Specifically, the complaint alleged that to promote the device, used in spinal fusion procedures, Medtronic paid millions in consulting...

USA -
FDA proposes new fast path to market for certain medical devices

The U.S. Food and Drug Administration on Monday proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approval. Commissioner Scott Gottlieb announced the proposal in a blog posted on the FDA’s website. If implemented, it could save device companies millions of dollars in product testing and shave years off development times. The proposals make good on President Donald Trump’s promise to cut regulations and sparked concern from public health advocates who fear the moves will harm patients. Already dozens of...

Europe -
Dans quels cas les LAP sont des DM - Affaire Snitem et Philips France c/ Ministre de la santé - arrêt CJUE sur questions préjudicielles

La CJUE vient de rendre sa décision dans l'affaire C329/16 Snitem et Philips France c/ Ministre de la santé, et a entériné les conclusions de l’Avocat Général. La CJUE retient qu'un logiciel d'aide à la prescription (LAP) constitue un dispositif médical au sens de la Directive 93/42 dès lors que l’une des fonctionnalités de ce logiciel permet l’exploitation de données propres à un patient, aux fins, notamment, de détecter les contre‑indications, les interactions médicamenteuses et les posologies excessives, et ce même si un tel logiciel n’agit pas directement dans ou sur le corps humain. La...

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