Postmarket surveillance procedures were once "nice to know" information. Nowadays, they are "need to know" since the FDA now requires manufacturers to conduct postmarket surveillance. You have only 30 days to develop a PS plan and submit to CDRH for approval once an order is issued.
In a new Medical Device Daily audio conference, Elaine Tseng, former FDA Regulatory Counsel, reveals what you need to know to comply with a postmarket surveillance order. She'll describe postmarket surveillance plans that can meet FDA requirements, and can be "least burdensome" to implement and explain what should be in your PS plan.
"How to Comply with New Medical Device Postmarket Surveillance Requirements" is just $349 per listening site. Scheduled for December 4th, from 1-2:30pm ET, it includes presentation handouts and a Q&A session with the speaker. A conference CD (MP3 format) is also available. Please call 800-688-2421 or 404-262-5474 and mention conference code T08524.