The training program will cover the roles of each legal perspective and how it might work towards regulating laboratory-developed tests (LDTs). The FDA has proposed to actively regulate LDTs. FDA’s regulations overlap with the Clinical Laboratory Improvement Act that falls under the Centers for Medicare and Medicaid Services (CMS).
Why Should You Attend:
The webinar will map out the legal players in the legal skirmish for regulating LDTs. For decades the FDA used enforcement discretion for LDTs, which meant the FDA held its regulatory controls in abeyance. In light of the FDA’s recent draft guidance on regulating LDTs, the webinar will address how FDA plans to actively regulate in-vitro diagnostic laboratories that produce LDTs.
Who Will Benefit:
Laboratory service providers for LDTs
Pathologists and medical practice groups
Third-party insurers/ reimbursement
Patient advocacy groups
In-vitro diagnostic manufacturers
Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an associate center director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value.
Use coupon code 232082 and get 10% off on registration.