Problems Caused By Regulatory Delays And Lack Of Regulation

An FDA perspective on some of the problems encountered during the device review process is describe& Emphasis is placed on the need for communication and teamwork among all parties to make the system work. Manufacturers are encouraged to 'Do it right the first time.' Pertinent questions are asked of the manufacturers and proposed solutions are presented. Day to day reality at FDA is described and document workload is revealed. Lack of regulation, or more appropriately, when less regulation is appropriate is discussed, FDA has distributed to manufacturers a new draft guidance document to help in the decisionmaking process and when to submit a 510(k) when modifications are made to a device. This and other mechanisms are in place at the FDA to streamline the review process. Manufacturers are cautioned about their decisions and to seek advice from qualified persons. FDA emphasizes that help is available and that when in doubt, call.