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| Expert Advice on the FDA |
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Earlier this month I attended Dr. Eli Orbach's seminar, "FDA Approval of Medical Devices: What You Need to Know." This veteran professional in the regulatory industry provided the participants with some excellent insights and knowledge for navigating a critical, but often confusing, subject.
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What Is a Device?
According to the FDA, the term device means an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is:
- recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes."
Orbach pointed out that under this definition, even a cane for walking can be a medical device and subject to marketing approval.
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Held in a Tel Aviv hotel, the all day event was sponsored by In Other WORDS, one of Israel's leading technical communications companies. Orbach, of International Regulatory Consultants, is a biophysicist with 20 years of multidisciplinary experience in the biomedical industry. He is an engaging speaker who kept the attendees alert and interested throughout the day.
To introduce his subject, Orbach presented a clear, comprehensive overview of the procedures and considerations involved in applying for FDA marketing approval of medical devices. In a concise, logical way, Orbach provided anyone developing a medical device with the ability to understand precisely where they stand in regard to classifying their device and going about getting the appropriate type of application.
Orbach then proceeded to give a history of the Food and Drug Law, explain the structure of the FDA, and discuss the tangle of terms and acronyms whose use can trip up anyone.
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| The FDA, Just a Phone Call Away?
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Overwhelming to new applicants, Orbach reassured participants that it is actually possible to obtain personal assistance in sorting it all out. First, he reviewed the FDA and the Center for Devices and Radiological Health (CDRH) websites. (The CDRH is the section of the FDA that deals with medical devices.) He also emphasized the importance of looking for information on the Division of Small Manufacturers Assistance (CDSMA) website.
Then, Orbach went on to explain that it used to be virtually impossible to contact anyone directly at the FDA, let alone ask questions about devices and procedures. Fortunately, those days are long gone. Now, he remarked, it is completely acceptable and comparatively easy. Names and contact information of all the relevant people are published on the website. With a little persistence (sending e-mails, setting convenient times to phone), it is possible to speak directly to the people in a particular area. He added that they are friendly and helpful.
It appears, too, that the U.S. government has tried to help manufacturers cope with the approval process by passing the Food and Drug Administration Modernization Act of 1997 — wide-ranging legislation with measures to accelerate the review of devices and to find the least burdensome clinical trials to demonstrate reasonable (a new concept) safety and effectiveness.
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| Taking the First Step
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Companies developing medical devices should be in contact with the FDA very early in their development process in order to understand the type of approvals needed or the standards and regulations they may need to comply with. Orbach pointed out that initially the most important thing a company should do is determine the class of device and which marketing application is appropriate for it by carefully reading the regulations, then verifying by contacting the FDA. Orbach noted that this step is extremely important for early-stage companies seeking investment money for two reasons: (1) the type of procedure necessary affects the investment, and (2) it is an important aspect of the business plan.
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The Trendletter team welcomes your comments.
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Naomi Alper
Senior Project Manager
The Trendlines Group
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