FDA's SECOND LDT Webinar to be held on June 5, 2024
FDA WEBINAR - FINAL RULE: MEDICAL DEVICES; LABORATORY DEVELOPED TESTS
On Wednesday, June 5, 2024, the US Food & Drug Administration will hold its second webinar on LDTs since the new rule was released, which is expected to summarize the two guidance documents released with the final rule:
- FDA Guidance: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
- FDA Guidance: Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency
It is expected to be a high-level presentation summarizing the guidance documents. The FDA will commit a portion of the webinar to provide responses to questions submitted to their dedicated webinar mailbox.
Details about the upcoming webinar and the mailbox for submitting questions can be found here:
FDA's first LDT Webinar held on May 14, 2024
FDA WEBINAR - FINAL RULE: MEDICAL DEVICES; LABORATORY DEVELOPED TESTS
On May 14, 2024, the US Food & Drug Administration held its first webinar for LDTs since the final rule was issued, which was introductory and reviewed the content of the final rule. There was a Q&A session as part of the webinar. The webinar covered the following topics:
- Provided an overview of the final rule amending the FDA's regulations to make it explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory; and
- Described the phaseout of the FDA's general enforcement discretion approach to laboratory developed tests (LDTs).
Review the webinar deck and video here:
FDA Final rule on ldt ISSUED on may 6, 2024
FDA FINAL RULE - MEDICAL DEVICES; LABORATORY DEVELOPED TESTS
On May 6, 2024, the US Food & Drug Administration issued its final rule, which makes explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. The rule becomes effective July 5, 2024.
The final rule sets several stages and dates where compliance must be achieved.
Read the final rule here:
The FDA also released two guidance documents with the final ruling on May 6th:
- "Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564", which can be read here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-certain-in-vitro-diagnostic-devices-immediate-public-health-response-absence
- "Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency", which can be read here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/consideration-enforcement-policies-tests-during-section-564-declared-emergency
