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.
Sauberman
H R
HR
Office of Device Evaluation, United States Food and Drug Administration, Rockville, Maryland, USA.
D003257:Consumer Product Safety; D006801:Humans; D010036:Otolaryngology; D019736:Prostheses and Implants / Q000592:standards* / Q000706:statistics & numerical data*