Laboratory Developed Tests (LDT) - The Impact of the Final Rule

Lab Developed Tests are IVDs under the US FDA definition, including when the manufacturer of the IVD is a laboratory. IVDs are intended for use in the collection, preparation, and examination of specimens taken from the human body, and can be used to measure or detect substances or analytes in the body to provide information about a patient's health, including to diagnose, monitor, or determine treatment for diseases and conditions.

The LDT final rule amends the FDA's regulations to make explicit that IVDs are devices under the FD&C Act, including when the manufacturer of the IVD is a laboratory. This amendment is not specific to certain types of LDTs, but rather relates to all IVDs manufactured by laboratories. In addition, the preamble to the LDT final rule describes a tailored phaseout policy under which the FDA will provide greater oversight of IVDs offered as LDTs through a phaseout of its general enforcement discretion approach for LDTs over the course of four years. The phaseout policy includes targeted enforcement discretion policies for specific categories of IVDs, including policies for currently marketed IVDs offered as LDTs and LDTs for unmet needs under certain circumstances.  As described in the preamble to the final rule, the FDA intends to exercise enforcement discretion with respect to premarket review and most Quality System (QS) requirements for currently marketed IVDs offered as LDTs that were first marketed before the LDT final rule issued. Additionally, as described in the preamble to the final rule, the FDA intends to exercise enforcement discretion with respect to premarket review and most QS requirements for LDTs manufactured and performed by a laboratory integrated within a health care system to meet an unmet need of patients receiving care within the same health care system. However, FDA expects compliance with other device requirements for IVDs falling within these policies.

Why You Should Attend:

The FDA is phasing out the general enforcement discretion approach for LDTs so that IVDs manufactured by laboratories will generally fall under the same enforcement approach as other IVDs. Compliance with device requirements under the FD&C Act will help assure IVDs offered as LDTs are appropriately safe and effective and put patients in a better position to have confidence in IVDs regardless of where they are manufactured. Device requirements include, among others:

• Adverse Event Reporting
• Establishment Registration
• Device Listing
• Labeling Requirements
• Investigational Use requirements
• Quality System Requirements
• Premarket Review

Areas Covered in the Session :

• The LDT final rule 
• LDTs are IVDs
• The FDA's various enforcement options with LDTs
• Reductioin in uncertainty re FDA and LDTs
• The meaning of the FDA's "enforcement discretion
• Key changes under the Final Rule
• Modified and unmodified LDTs

Who Should Attend:

• Senior management in Devices, Combination Products
• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Medical Device product development teams
• Consultants

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.