Navigation Links
Five Tips for Quick FDA 510k Clearance for Medical Devices

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 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". The full definition of a medical device can be found at The FDA tends to interpret "other conditions" broadly: for instance, a device to treat facial wrinkles is considered a medical device, even though wrinkles can hardly be called a "disease".

(2) Make sure the classification of the device is correct.
The classification of a device can be difficult. The FDA has extensive lists of device classifications, identified by product code. Each product code refers back to a specific section in the FDA regulations. If a device does not fit into any of these classifications, one must select the classification that is "closest". A company can get some pointers by looking up the classifications of a competitor's devices. If still unsure what to do, a company representative should ask the FDA's Division of Small Manufacturers.

(3) Determine who will be the owner of the 510(k), and who will be the official correspondent.
Before legally selling a medical device in the USA, the device must have FDA 510(k) clearance. The entity submitting the 510(k) request can be a FDA consultant, the manufacturer, a distributor, or another stakeholder. The owner of the 510(k) must be clearly identified in the submission document. The official correspondent, who does not need to be the owner, must be clearly identified also.

(4) Use (a) predicate device(s) that is close to the new device.
The new and the predicate medical device should be close in intended use and technology. Intended use is more important than technology. If the new medical device combines features of multiple devices, one may be able to use multiple predicates, each representing some of the features of the new medical device. If the new device uses an existing technology for a new intended use, don't expect a speedy process, but negotiate an acceptable submission path with the FDA.

(5) Pay close attention to the formatting of the submission.
The FDA has published extensive guidelines and checklists to help companies format the document(s) to the FDA's liking. If the submission complies with these guidelines, the FDA will have an easier time to judge the merits of the submission. Keep in mind that FDA's reviewers may be specialists in the field, but this particular medical device is usually new to them. A transparent and well-organized submission makes it easier for the reviewer to understand the merits of the new device.

For more information about FDA medical device approval, visit or contact Nicolaas Besseling, FDA consultant.

About BesTech Consulting Services:
After 22 years leading medical equipment design and development teams at world-class firms such as Siemens Medical Solutions, Mr. Besseling started BesTech Consulting Services in 1996 to provide Regulatory Consulting services to medical device companies. The majority of BesTech's clients are small to medium-sized companies that need a personalized approach to their own problem resolutions.

BesTech Consulting Services

# # #

Read the full story at

Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Related medicine news :

1. Meditation a Quick Fix for Stress
2. Twinkle after effect can help retinal patients detect vision loss quickly and cheaply
3. Twinkle After-Effect Can Help Retinal Patients Detect Vision Loss Quickly and Cheaply and Prevent Further Loss
4. Thyroid treatment no quick fix for weight loss in children
5. Greenway Experiences Quick Success in the Community EHR Marketplace by Securing Contracts with 10 Community-Based Health Organizations
6. Mercury in Childhood Vaccines Excreted Quickly
7. Penn Treaty Introduces LTCi QuickPass(SM) Program
8. MITs PANTHER sensor quickly detects pathogens
9. New TB test means quicker and easier diagnosis for patients
10. Huron Capital Moves Quickly To Expand O&P Business
11. Researchers Develop Quick Way to Create Human Antibodies
Post Your Comments:
Related Image:
Five Tips for Quick FDA 510k Clearance for Medical Devices
(Date:11/27/2015)... ... ... According to an article published November 15th by ABC News, ... in light of the recent terrorist attacks in Paris, other cities are taking extra ... from reaching U.S. soil. Especially around special events that may be high-profile in nature, ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, from Hopkinsville, ... prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. , The ... medications. In doing so, it could help to prevent potential overdose situations. As ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... edition of USA Today in Atlanta, Dallas, New York, Minneapolis, South Florida, with ... digital component is distributed nationally, through a vast social media strategy and across ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... of progress through sharing, the 2016 Building Better Radiology Marketing Programs ... will begin on Sunday, March 6, 2016, at Caesars Palace in Las Vegas ...
(Date:11/27/2015)... ... November 27, 2015 , ... The moment you ... for not only fulfilling the needs of advisers and clients but going above ... and providing top-tier customer service. However, there's always room for improvement, which is ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)...  The total global healthcare industry is expected to grow ... Latin America has the highest projected growth at ... Japan ), is second with growth projected at 11.5%. ... healthcare expenditure. In 2013-2014, total government funded healthcare was nearly ... to 41.2% in 2013-2014. In real terms, out of pocket ...
(Date:11/25/2015)... Nov. 25, 2015  The American Academy of ... (ACOG), and the March of Dimes cheered today,s ... Our Infants Act of 2015 (S.799), which ... newborns born exposed to drugs, such as opioids, ... introduction, all three organizations have worked together leading ...
(Date:11/25/2015)... Nov. 25, 2015 AAIPharma Services Corp./Cambridge ... of at least $15.8  Million to expand its ... NC . The expansion will provide additional ... the growing demands of the pharmaceutical and biotechnology ... expansion will provide up to 40,000 square feet ...
Breaking Medicine Technology: