H R Sauberman | PubMed Health

PubMed1995

Approval process for implants in otolaryngology.

As the reader can see, the regulatory approval process for implant devices, especially those intended for use in otolaryngology, is complex. The procedural steps in filing IDE and PMA applications require an understanding of clinical trial design, sponsor responsibilities, investigator requirements and IRB oversight as well as concern for subject safety and welfare. For the most part, once these building blocks are in place and the events and procedures are understood, one can proceed in a fairly straightforward and efficient manner through the review and approval process.

Consumer Product Safety↗

PubMed1983

Impact of FDA regulations on the cochlear implant field.

An overview of the impact of the FDA's investigational device regulation on the field of the cochlear implants has been presented. It can be seen that the regulation has been established to provide a legal framework for conducting clinical investigations with medical devices. The regulation incorporates the concepts of institutional review and the informed consent of the patient. These concepts are not new; they have existed for a long time as part of medical research in the United States. We believe that the institutional review board will serve to effectively review and monitor the clinical course of patients receiving cochlear implants. We also believe that we have developed a regulation that maximizes patient safety, while encouraging investigation of the device. We understand and appreciate that IRB monitoring is far more efficient and effective than having FDA personnel on hand at various institutions around the country to monitor investigational studies. We know full well the added complexity that a bureaucratic monitoring process can bring to a clinical investigation. We think that the IRB approach is the most direct, straightforward, protective, and cost-effective approach that can be taken. We appreciate the benefit that a patient receives in having a competent and expert investigator. The regulations were written to rely on these investigators for expertise in their particular specialty in conducting and evaluating the clinical studies. We recognize the role of the sponsor, who has made a commitment to the improvement of health care through advancement in technology, and who seeks to restore or to produce some degree of hearing for the totally deaf. Without a sponsor, these studies would not be possible. And last, but not least, we recognize the all-important role of the patient, who provides the clinical data base. The patient's welfare and safety must be considered in any clinical study. The IDE regulation has been in effect since July 1980. It provides the opportunity for the FDA and the medical and scientific communities to work together for the success of medical-device investigations. We can all pride ourselves on our high standard of medical excellence. When we can work together, this standard will rise even higher.

Cochlear Implants↗

PubMedDate not supplied

The Ear, Nose, and Throat Devices Classification Panel of the Food And Drug Administration.

The passage into law in 1976 of the Medical Device Amendments authorized the FDA to regulate the safety and efficacy of medical devices. The effects of this regulation are contrasted with the mode of entry of medical devices onto the market prior to 1976. The structure and operation of Ear, Nose, and Throat Devices Classification Panel is described briefly. Continued input from otolaryngologists and allied professionals is encouraged.

Legislation, Medical↗