22 November 2008 E-MAIL SEARCH Home Page Newsroom From the Top Business Buzz Marketing Mix Financial Focus Management Matters PR Points Web Wisdom Industry Reports Business Glossary Resources U.S. Gov. Resources      FDA: What You Need to Know   Any company that develops a new medical device wants to market it in the United States, the world's largest single market for medical products. And that means getting market clearance (approval) from the U.S. Food and Drug Administration (FDA). In the majority of cases, obtaining this approval involves an application process and a significant amount of work and time. Understanding the approval process is very helpful, if not crucial, in successfully overcoming the barriers. Paving the Way with the FDA FDA Classifications and Approval Routes PMA: any premarket approval application for a class III medical device IDE: approved or considered approved investigational device exemption 510K: a submission for approval that demonstrates that the device to be marketed is substantially equivalent to existing devices Many medical device companies believe that the first time they will deal with FDA issues, or even the FDA itself, will come when they apply for their approval — but actually this may be too late, according to Dr. Eli Orbach, a seasoned regulatory professional and authority on FDA regulations and procedures. "At every stage, starting from the original idea for a medical product based on some novel or advantageous technology, there is important FDA-related input which the CEO/CTO should take into account in forming the company's strategy and plans," notes Orbach. The FDA issues range from definitions of the intended use of the product to identification of safety and effectiveness issues that need to be tackled during product development that can assure a viable product to estimating the time required to obtain regulatory approval. If you've spent months developing software for a medical device, but haven't kept the appropriate records or undertaken the appropriate testing, it's going to be a major headache to have to redo it. Or, if you've conducted various clinical trials at different hospitals following a protocol that the FDA may consider inadequate, it is going to take a great deal of analysis and explanation, if not doing the tests over, in order to verify your claims. "Manufacturers need to have a detailed understanding of the FDA's criteria and standards," says Orbach. "If you require clinical data to get your medical device approved, you have to ensure that the experiment is correctly carried out and that it provides the type of results the FDA wants to see." A Matter of Class Device Classes Class 1: low risk; often exempt from approval Class 2: approval by comparison with existing devices Class 3: high risk; premarket approval by demonstration of safety and effectiveness Every medical device must have labeling that describes its intended use, which should be defined at an early stage. Device classification and the type of approvals required depend on the intended use(s) of the device. "This is a very real issue," says Orbach. It is far more difficult to get approval for a device with a novel application than it is to get approval on a device with an accepted application. Manufacturers may find it advantageous, when appropriate, to get approval on well-known application of the device first (to get a foothold in the market) and then get approval on the novel application at a later time. Having a good grip on these issues doesn't just affect your chances of getting FDA approval, it can also have a significant impact on fundraising, points out Orbach, It is crucial to gain the confidence of investors that the company is led by knowledgeable people who understand the process and have structured their development plan accordingly. Collaborating with the FDA FDA website FDA — Center for Devices and Radiological Health "Device Advice Center" It used to be difficult to get feedback from the FDA, but no longer. The FDA Modernization Act of 1997 set out to open the channels of communication between manufacturers and the FDA and to encourage early collaboration. The idea is to smooth the path to FDA approval by explaining the process, determining what questions are going to be asked, and reviewing how evidence and arguments should be submitted. This works to the advantage of both the manufacturers and the FDA The FDA can serve as a partner in developing technology by helping to suggest approaches to address clinical testing needs and reduce risks, and warning against approaches or application strategies that won't make the grade. The path to FDA approval is paved with pitfalls. Having a sound regulatory strategy and getting good feedback from the FDA from product concept through completion can save both time and money. The Trendletter team welcomes your comments. ©2002–2008 Trendlines International Ltd. All rights reserved. Phone: +972.4.958.3323 | postmaster@trendlines.com Directions | Privacy Policy | Site Map This site contains material copyrighted by third parties. This site is best viewed in Internet Explorer version 5 or higher.