Direction or inertia: the future for regulation of surgical implant devices.

The time has arrived when certain standards are to be introduced to control the introduction of and appropriate use of surgical implant devices. Now is the time for the professional groups involved in standards and medical device legislation to become active and develop surgical implant device standards to be applicable for the future. A commission could be established to work with FDA in respect to the requirements for surgical implant devices. It is time for the clinical organizations involved in writing consensus standards to cooperate in the introduction of surgical implant device standards.