FDA Response Expected Expected Soon for Bovie (AMEX:BVX)

On August 3, 2009, Bovie Medical Corporation (AMEX:BVX) announced that it has submitted a 510(K) to the FDA, for its ICON VS electrosurgical generator, in order to obtain pre-market approval. We hope the company will get a response from the FDA after 6 months, around February 3, 2010. However, the FDA may not give its decision on this date and there is no way to find out when it will, since the FDA is not bound by law to notify about decision dates for any submission, such as 510(K), related to medical devices.

So, what exactly is a 510(K) submission? It is an application submitted to the Centre for Devices and Radiological Health (CDRH), an organ of the FDA, by companies who want to commercialize a line of medical devices that they have developed. Almost all medical devices need the submission and approval of the 510(K) application. The 510(K) submission basically allows the company to prove to the Food & Drug Administration that the medical device is both safe and effective. On the other hand, the 510(K) submission may also show how the medical device is same as a predicate device, that is, a device that is already legally available in the market and does not require submitting a pre market approval to the FDA.

In general, a 510k submission contains information about a description of the medical device, about data related to its clinical, preclinical and non clinical performance, about the labeling of the medicine equipment, about the instructions on how the device must be used, about other comparative products about a description of any software or firmware that has been used in the medical device.

Since the Center for Devices and Radiological Health (CDRH) gets about 4000 510(K) submissions every year, the Food and Drug Administration cannot submit an immediate response to the company who submits an application. The Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), both of which are in the CDRH, are responsible for processing and reviewing 510(k) submissions. The FDA reviewers, who will determine whether a new medical device is safe, effective and thus can be marketed in the United State, are usually physicians, biomedical engineers, chemists, microbiologists, and other professionals. In general, the FDA issues a response to a 510K submission within 90 days. However, Bovie Medical Corporation is expecting a response much later than 90 days.

If the ICON VS electrosurgical generator gets approved, it will be used with its Seal-N-Cut line of medical instruments. The generator is completely digital and extremely user friendly which allows the surgeons to choose what actions they want to perform with the Seal-N-Cut instrument. The Seal-N-Cut medical device line consists of hybrid (i.e. a combination of) monopolar and bipolar forceps. The monopolar forceps give out monopolar energy during a surgery while the bipolar forceps give out bipolar energy. As a result, this innovative Seal-n-Cut device can provide both monopolar and bipolar energy. It is also based on another innovative function: receiving intelligent feedback that comes from the Hybrid VS electrosurgical generator, also manufactured by Bovie Corporation.