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.
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.
(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 http://www.fda.gov/cdrh/devadvice/312.html. 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 www.bestechconsulting.biz or contact Nicolaas Besseling, FDA consultant.
Source: Medical Design Online