Preparing for the LDT Regulation - Webinar CD/Transcript
Preparing for the LDT Regulation: CLIA Won’t Satisfy the FDA
FDA has long asserted that design and manufacture of Laboratory Developed Tests (LDTs) falls under the device regulations. CLIA regulations apply to performing the tests and do not meet the device regulations.
Come up short in an inspection and the FDA can issue a Form 483, as recently happened with Theranos. They explained: “All observations were specific to the nanotainers [blood specimen device] operating under the CLIA lab quality framework. The correction to the observations was to cut over to the FDA Quality Systems framework.” The solution is to draw a bright line between device operations and laboratory operations.
Laboratories will not be ready to become device manufacturers without a lot of work. The regulations are extensive have many differences, with more rigorous requirements, than the CLIA regulations. Compliance will be a major project for labs requiring planning, resources, and money.
This presentation provides practical information you need to understand the FDA’s intentions. It provides vital information a lab needs to prepare for the change. For example, the various timelines are confusing, but the webinar uses diagrams and simple explanations to clarify the issues.
In 90 minutes you will learn:
- The need to notify FDA of all LDTs within six months
- The new requirements for adverse event reports that apply to LDTs
- The role of registration and listing, and the current fees
- The requirements for premarket review, the timing, and fee issues
- The structure of FDA’s schedule for premarket review
- LDTs that FDA won’t regulate