# #340: LDTs & the FDAs Proposed Ruling

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-10-19
- Length: 46m
- Episode: 340
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling
- Listen: https://podcast.greenlight.guru/episode/340-ldts-the-fdas-proposed-ruling

## Summary

Shannon Bennett, Director of Regulatory Affairs, joins host Etienne Nichols to dissect the FDA's October 2023 proposed rule to regulate Laboratory Developed Tests (LDTs) as medical devices. Bennett outlines the four-year phased implementation plan, detailing the shift from CLIA oversight to FDA requirements for adverse event reporting, registration, and Quality System Regulation (QSR) compliance. He highlights the massive administrative burden, estimating 80,000 to 100,000 submissions and $55 billion in annual industry costs, while discussing the potential disruption to patient access and the need for clear guidance on risk categorization and new test submissions.

## Chapters

- [0:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling#t=59) Introduction to LDTs and FDA Proposed Rule
- [4:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling#t=295) LDT vs IVD Definitions and Regulatory History
- [10:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling#t=605) The Valid Act and IVCT Concept
- [12:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling#t=760) CLIA Baseline and Industry Regulation Reality
- [21:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling#t=1316) Year 1: Adverse Event Reporting Challenges
- [23:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling#t=1438) Year 2: Registration, Listing, and Labeling
- [25:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling#t=1541) Year 3: QSR/GMP and Design Controls
- [30:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling#t=1855) Years 3.5 and 4: PMA Submissions and Volume
- [35:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling#t=2141) Technology Certification and Future Guidance
- [42:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling#t=2534) Conclusion: Disruption and Call to Action

## Topics

- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

large enterprises

## Mentioned

- Greenlight Guru (company)
- FDA (company)
- CLIA (other)
- Valid Act (other)
- CMS (company)
- CAP (company)
- EU MDR (other)
- ISO 13485 (other)

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## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-19-340-ldts-the-fdas-proposed-ruling. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.