# When to Throw the Least Burdensome Flag on FDA

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-10-06
- Length: 34m
- Episode: 230
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-06-when-to-throw-the-least-burdensome-flag-on-fda
- Listen: https://podcast.greenlight.guru/episode/when-to-throw-the-least-burdensome-flag-on-fda

## Summary

Mike Drues, President of Vascular Sciences, explains how medical device manufacturers can respond to overly burdensome Additional Information Requests (AIR) from the FDA using the 'Least Burdensome Flag' pilot program. He outlines a hierarchy of responses, starting with informal negotiations with reviewers to reach a compromise, escalating to division management, and formally invoking the flag if necessary. Drues emphasizes that companies must justify testing requests based on biology and engineering rather than blindly complying, warning that the 'nuclear option' of involving the Ombudsman can damage long-term relationships with the agency.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-06-when-to-throw-the-least-burdensome-flag-on-fda#t=0) Introduction: Mike Drues and Vascular Sciences
- [1:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-06-when-to-throw-the-least-burdensome-flag-on-fda#t=117) Context: Pushing Back on Overly Burdensome FDA Requests
- [6:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-06-when-to-throw-the-least-burdensome-flag-on-fda#t=393) Case Study: Biocompatibility Testing and Polyurethane Foam
- [8:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-06-when-to-throw-the-least-burdensome-flag-on-fda#t=500) Informal Options: Compromise and Escalation Tactics
- [12:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-06-when-to-throw-the-least-burdensome-flag-on-fda#t=773) The Least Burdensome Flag: Criteria and Mechanics
- [19:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-06-when-to-throw-the-least-burdensome-flag-on-fda#t=1142) The Nuclear Option: The Ombudsman and Last Resort
- [23:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-06-when-to-throw-the-least-burdensome-flag-on-fda#t=1388) Strategy: Calling the FDA's Bluff and Justifying Testing
- [29:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-06-when-to-throw-the-least-burdensome-flag-on-fda#t=1770) Conclusion: Mutual Respect and Knowing Your Product

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Greenlight Guru (company)
- FDA (other)
- CDRH (other)
- 510(k) (other)
- IDE (other)
- ISO 10993 (other)

## Related episodes from other shows

- [077 - 8 Databases and How To Use Them with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott) (Let's Combinate)
- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (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)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (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/2021-10-06-when-to-throw-the-least-burdensome-flag-on-fda. 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.