# Ad Promo and The Difference in Regulatory & Legal

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-05-24
- Length: 1h 26m
- Episode: 320
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal
- Listen: https://podcast.greenlight.guru/episode/ad-promo-and-the-difference-in-regulatory-legal

## Summary

Mark DuVal, founder of Duval & Associates, explains the '4 buckets' framework for medical device promotion: on-label promotion, off-label dissemination, off-label communication, and the emerging fourth bucket of off-label promotion with disclosures. He contrasts the scientific perspective of regulatory affairs professionals with the advocacy-driven approach of regulatory attorneys, emphasizing the legal tension between FDA enforcement and First Amendment rights established in cases like *Howard Root* and *Washington Legal Foundation*. DuVal details how companies can navigate these boundaries using guidance documents, ensuring all communications are 'truthful, not misleading, and fairly balanced,' while managing risks like strict liability for executives and compliance monitoring of contract sales forces.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal#t=0) Introduction: Mark DuVal and Duval & Associates
- [6:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal#t=385) Regulatory Strategy and the 510(k) Pathway
- [10:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal#t=627) Regulatory Affairs vs. Regulatory Attorneys
- [15:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal#t=930) The 4 Buckets of Information Flow
- [27:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal#t=1629) Off-Label Promotion and the Howard Root Case
- [31:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal#t=1876) Fair Balance, Social Media, and Compliance
- [45:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal#t=2730) Staged Regulatory Strategy and Real World Evidence
- [1:02:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal#t=3770) General vs. Specific Intended Use

## Topics

- [Marketing & brand](https://hardwarepodcasts.com/topic/marketing-and-brand)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Duval & Associates (company)
- FDA (other)
- Washington Legal Foundation (other)
- Howard Root (other)
- 3M (company)
- Coaxia (company)

## Related episodes from other shows

- [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)
- [056 - "Non-Promotional Compliance" with Darshan Kulkarni](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-26-056-non-promotional-compliance-with-darshan-kulkarni) (Let's Combinate)
- [#216 - Food Labeling Law 101 with Lauren Handel](https://hardwarepodcasts.com/podcast/the-startup-cpg-podcast/2025-09-30-216-food-labeling-law-101-with-lauren-handel) (The Startup CPG Podcast)
- [135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su) (Let's Combinate)
- [204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-03-204-the-dictionary-thesaurus-of-combination-products-finally-explained-with-susa) (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/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal. 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.