DESIGN AND DEVELOPMENT OF MEDICAL ELECTRONIC ...

444 EPILOGUEAll data supplied by the manufacturer is subjected to thorough, independent review byFDA employees and medical advisors, including specialized medical devices advisorypanels composed of scientists and practicing physicians. If the reviewing team makes apositive recommendation for approval, a manufacturing site inspection is conducted by theFDA. A final notification of the FDA decision is mailed to the manufacturer following concludingdiscussions.ExceptionsThere are some exceptions to these rules. Medical devices that have not been approved bythe FDA for marketing can be used with human subjects under a Humanitarian DeviceExemption (HDE), an Investigational Device Exemption (IDE), or a Product DevelopmentProtocol.Humanitarian Use Devices (HUDs) are devices intended to diagnose or treat a conditionthat affects fewer than 4000 U.S. patients per year. The HDE application is similar toa PMA but does not require the manufacturer to demonstrate effectiveness, only safety.This path was provided through the 1990 Safe Medical Devices Act as a way to reduce thefinancial burden of R&D in the development of devices with limited market potential, butwhich may provide benefit to the patients who need them.A clinical trial for a device may be conducted through an investigational exemption tothe restraint on commercial distribution of unapproved medical devices. An IDE applicationrequires sufficient evidence of the device’s safety and a reasonable expectation ofeffectiveness to warrant its testing in humans. The FDA recognizes the investigationalnature of a clinical trial done under an IDE, allowing fewer rigors than in a PMA application.Nevertheless, important safety issues must be addressed through thorough bench andanimal testing before using the device on human subjects. The use of a medical deviceunder an IDE is very restricted:• The device can be made available only to designated investigators.• The device is to be used only under the terms of the approved IDE application.• Designated investigators are responsible for ensuring that the investigation adheres tothe investigational plan as well as any and all conditions imposed by the host hospital’sInstitutional Review Board (IRB) and the FDA.• The rights, safety, and welfare of subjects is maintained according to ethical guidelinesof the World Medical Association Declaration of Helsinki.• Strict control is maintained over the devices under investigation.Finally, section 515(f) of the FD&C Act provides an alternative to the PMA process forclass III devices. A Product Development Protocol (PDP) should be submitted by the manufacturerto the FDA very early in a device’s development cycle. The PDP defines the typesof data and specific safety and performance levels that the device must achieve to receivemarket clearance. The product can be introduced to the market as soon as the FDA verifiesthe manufacturer’s data, showing that it meets the preestablished safety and performancelevels.MARKETING AN IDEADespite the strong skepticism that is commonly encountered by new biomedical technologies,market statistics show that investors are eager to back medical device ventures. Infact, a recent survey by Medical Device and Diagnostic Industry magazine indicated that