The FDA Process

The FDA process is discussed generally in the context of the type of clearance anticipated can be obtained for the medical devices.

A. The 510(k) Process - Class I and II Devices

Devices classified by the FDA as posing less risk are placed in Class I or Class II. Class I or II only require the manufacturer to seek a 510(k) clearance from the FDA.

The clearance is generally granted when the submitted information establishes that a proposed device is:

1. "Substantially Equivalent" in intended:

1. use
2. safety, and
3. effectiveness

2. to a "predicate device" which is either:

1. a Class I or II device already legally on the market; or
2. "preamendment" Class III device (one that has been in commercial distribution since before May 28, 1996) for which the FDA has not called for PMA applications.

Process takes from 4 to 12 months from date of submission. FDA may determine that it needs additional information or that the proposed product is precluded from receiving clearance because it is not substantially similar to a predicate device.

After clearance is received, any modifications that:

1. could affect the device's safety or effectiveness, or
2. would constitute a major change in the intended use of the device

will require a new 510(k) submission.

While the devices incorporate the novel patented features, it can be strongly argued that they also utilize electrosurgical principles widely understood and are substantially equivalent to other Class I or II predicate devices already legally on the market.

B. PMA - Class III Devices

If, for some chance, a device does not qualify for the 510(k) clearance it is placed into Class III, which is reserved for devices classified by the FDA as posing the greatest risk in that they are:

1. Life-sustaining,
2. Life-supporting or implantable devices; or
3. Not substantially equivalent to a predicate device.

The PMA submission requires a more in-depth review and procedure and may take from 1 to 3 years, or longer.

C. Clinical Trial

A clinical trial in support of a 510(k) submission or PMA application requires an Investigative Device Exemption ("IDE") application.

A. Regular Procedure
The IDE application must be approved by the FDA:

1. In advance; and
2. For a limited number of patients.

B. Shortcut
If device presents a "nonsignificant risk" to the patients, the sponsor may begin the clinical trial after obtaining approval for the study by one or more institutional review boards ("IRBs") without the need for the FDA approval.

However, there is no assurance that the FDA will agree with the determinations of the IRBs and not require the sponsor to obtain the approval of the IDEs before continuing the clinical study.

Submission of the IDE application does not assure FDA will approve it, or if approved, that the FDA will determine that the data derived from the clinical studies supports the substantial equivalence or the safety and efficacy of the device or even warrant the continuation of the clinical trial.

D. Summary

Since the devices rely on known electrosurgical principles and operate utilizing approved electrosurgical generators, a strong argument exists that the devices present a "nonsignificant risk" to patients when compared to existing monopolar devices.