Medical Devices
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How To Market Your Medical Device
Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s1 and Premarket Approvals. Introduction One of the most difficult aspects of getting a medical device to market is KNOWING WHERE TO BEGIN i.e., what are the steps for marketing and in what order they are to be taken. Essentially, medical devices are subject to the general controls3 of the Federal Food Drug & Cosmetic (FD&C) Act4 which are contained in the final procedural regulations in Title 21 Code of Federal Regulations Part 800-1200 (21 CFR Parts 800 - 12995). These controls are the baseline requirements that apply to all medical devices necessary for marketing, proper labeling and monitoring its performance once the device is on the market. Three Steps to Obtaining Marketing Clearance from CDRH STEP ONE in the marketing process is to make absolutely sure that the product that you wish to market is a medical device6, that is, does it meet the definition of Read More... -
Is The Product A Medical Device?
Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s1 and Premarket Approvals, Introduction Determine if your product meets the Definition of a device. If it does, there are FDA requirements that apply. First, see the definition below. Medical Device Definition Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products3 with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Read More... -
Buying Medical Devices and Diagnostic Tests Online
Many consumers consider buying medical devices on-line. The medical devices include such products as hearing aids, contact lenses, magnets, and laboratory diagnostic test kits. What is considered a medical device? The Food, Drug, and Cosmetic Act defines a medical device as an instrument, a machine, an implant, or a diagnostic test used to help diagnose a disease or other condition or to cure, treat, or prevent disease. Types of medical devices range from thermometers to artificial hearts to at-home pregnancy test kits. Buying online has advantages, but it also can produce pitfalls for some consumers. Buying on-line offers privacy, convenience and potential cost-savings, but personal data given by the consumer can be misused by unscrupulous dealers. While the Internet offers many quality medical devices from legitimate sites, it also offers medical devices that don't work and some that may even harm you or your family. Some Web sites sell medical devices for unapproved uses, or t Read More...
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