# Understanding FDA's New Intended Use Rule and its Implications

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-08-11
- Length: 35m
- Episode: 223
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-08-11-understanding-fdas-new-intended-use-rule-and-its-implications
- Listen: https://podcast.greenlight.guru/episode/understanding-fdas-new-intended-use-rule-and-its-implications

## Summary

Mike Drues of Vascular Sciences joins host Jon Speer to dissect the FDA's new 'intended use' rule, explaining how labeling content—categorized as high-level (intended use, indications for use) and low-level (directions for use)—determines regulatory burden. Drues details the concept of 'manufacturer's objective intent,' which holds companies responsible for inferred or implied uses if they have knowledge of such applications, closing loopholes previously exploited by device naming strategies. The discussion highlights the strategic trade-offs between minimizing regulatory evidence requirements and managing product liability and reimbursement risks, using stents as a key example of off-label use implications.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-08-11-understanding-fdas-new-intended-use-rule-and-its-implications#t=0) Introduction: Jon Speer and Mike Drues on FDA's Intended Use Rule
- [2:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-08-11-understanding-fdas-new-intended-use-rule-and-its-implications#t=162) Defining Labeling: High-Level vs. Low-Level Claims
- [6:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-08-11-understanding-fdas-new-intended-use-rule-and-its-implications#t=382) Strategic Labeling to Minimize Regulatory Burden
- [10:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-08-11-understanding-fdas-new-intended-use-rule-and-its-implications#t=648) Intended Use vs. Indications for Use: Device vs. Patient
- [14:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-08-11-understanding-fdas-new-intended-use-rule-and-its-implications#t=889) Manufacturer's Objective Intent and Inferred Claims
- [22:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-08-11-understanding-fdas-new-intended-use-rule-and-its-implications#t=1368) Stent Loopholes and Off-Label Use Enforcement
- [27:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-08-11-understanding-fdas-new-intended-use-rule-and-its-implications#t=1674) Product Liability and Reimbursement Implications
- [31:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-08-11-understanding-fdas-new-intended-use-rule-and-its-implications#t=1882) Takeaways: What You Say vs. What People Hear

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- FDA (other)
- CDRH (other)
- CMS (other)
- Jolt Cola (product)
- Lazy Cakes (product)
- stents (product)

## Related episodes from other shows

- [143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r) (Let's Combinate)
- [047 - "Truthful Not Misleading" with Darshan Kulkarni](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni) (Let's Combinate)
- [055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis) (Let's Combinate)
- [137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-22-137-the-3-levels-of-reliability-fault-tree-analysis-needle-safety-emergency-use) (Let's Combinate)
- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (Let's Combinate)

## 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/2021-08-11-understanding-fdas-new-intended-use-rule-and-its-implications. 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.