Webinars>>Lab Developed Diagnostic Tests (FDA Regulation and Compliance)
New Rules for FDA Regulation of Lab Developed Diagnostic Tests (LDT)
For the last two years, since the announcement of new rules for regulating LDTs, FDA has been aggressively enforcing better testing, registration and marketing of LDTs. Currently there are more than 4000 LDTs offered by hundreds of lab across the country subject to the new rules. These new rules intend to change the entire landscape of LDT regulation by FDA.
Under these rules, there is a new classification for LDTs based on the perceived risk, and new rules for registration, testing, approval and adverse event reporting requirements for LDTs. In the near future, FDA intends to apply enforcement discretion for the premarket approval requirements and quality system regulations, but these discretions will also be phased out in the next few years.
Why should you attend:
Since the announcement of these rules, there has been intense discussion on the utility and practicality of these rules. The industry is worried that these may discourage innovation and access to widely used tests now routinely used by healthcare professionals. On the other hand, FDA strongly believes these rules are needed in the current landscape where these tests are widely used and raise significant concerns about their safe use by patients and physicians alike.
This seminar will discuss the current rules and practical tips for being compliant to the current rules. The instructor will provide advice based on his extensive regulatory experience on the best and worst case scenarios for various kinds of LDTs under current regulations.
This seminar is intended for general instructions to all LDT providers such as laboratories, clinics, physicians, hospitals, reimbursement experts, clinical trial users, and regulators who wish to have a better understanding of how FDA intends to regulate LDTs.
Areas Covered in the Session:
Who will benefit:
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: email@example.com