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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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How to prepare your medical device company for an FDA inspection

The FDA has arrived at your premises. What is your reaction? Are you ready? If you’re lucky, the FDA might have announced that they’re coming, but otherwise, they may turn up at any time. This means your company needs to be prepared at all times to go through an inspection. Here are some of the issues that we commonly see medical device companies trip over: Be prepared! People often hear that an inspection will happen, but don’t really believe it. Inspections are mandated, particularly for Class II or III medical devices. You will be inspected and the inspection may or may not be announced...

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Webinar - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Webinar Materials Presentation (WMV - 253.6MB) Printable Slides (PDF - 292KB) Transcript (PDF - 249KB) On Tuesday, October 10, 2017, from 1:00-2:30 PM EST, the FDA will host a webinar for industry interested in learning more about the final guidance document “ Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices .” This guidance is applicable to all devices, as that term is defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act); including software that meets the definition of a device. This guidance clarifies how the agency...

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FDA Finalizes Guidance on Medical Product Classification

On September 26, 2017, FDA announced in a Federal Register notice the availability of the final guidance document, Classification of Products as Drugs and Devices & Additional Product Classification Issues . This guidance provides the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues, such as the request for designation (RFD) process. The guidance combines and finalizes two draft guidance documents from 2011: Classification of Products as Drugs and Devices and Additional Product Classification...

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