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Five Tips for Quick FDA 510k Clearance for Medical Devices

Date:4/11/2009

FDA medical device approval, also known as the FDA 510k process, can easily take much longer than anticipated due to common mistakes or omissions. Here are five tips to avoid some of those mistakes.

Laguna Niguel, CA (PRWEB) April 11, 2009 -- Companies that have an idea for a new medical device are often confused about what they need to do to get the product cleared through the FDA. Most companies are not knowledgeable of FDA medical device approval regulations and need the assistance of an FDA consultant who can guide them in getting the product to market. Getting FDA 510k clearance is easier with the support of a professional.

"FDA reviewers are human, and if you make their life easier by making sure your device is regulated by the FDA, the device is properly classified, the lines of communication are defined, the predicate devices are appropriately selected, and the submission is formatted to their requirements, the FDA 510k reviewer can focus on the merits of the submission," says Nicolaas Besseling, FDA consultant with BesTech Consulting Services.

"Treat FDA reviewers with respect, courtesy and honesty, and you will be rewarded with a smoother path towards 510k clearance of your medical device. Nothing works more effectively against you than a reluctant reviewer, who may scrutinize your submission much more than one who is treated fairly." -- Nicolaas Besseling.

(1) Find out if the FDA regulates the device.
This may sound very basic, but it happens that a manufacturer thinks his device is classified as a medical device, but it isn't. A medical device is "intended
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Source: PRWeb
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