# #429: MedTech Regulatory Risk: Navigating the FDA During a Government Shutdown

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-10-20
- Length: 22m
- Episode: 429
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-20-429-medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown
- Listen: https://podcast.greenlight.guru/episode/medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown

## Summary

Michael Nilo, President of Nilo Medical Consulting Group and former FDA Scientific Reviewer, explains how a U.S. government shutdown impacts the Food and Drug Administration (FDA) and medical device companies. He details that while new user-fee-supported submissions like PMAs and 510(k)s halt, essential activities such as IDE reviews, post-market safety surveillance, and active review of already-filed submissions continue using existing user fee reserves. Nilo advises MedTech leaders to treat the shutdown as an uncontrollable natural disaster, using the delay to improve submission quality, finalize process validation, and strengthen commercial strategies to emerge stronger once the FDA reopens.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-20-429-medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown#t=0) Introduction: Michael Nilo and Nilo Medical Consulting Group
- [2:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-20-429-medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown#t=146) FDA Operations: What Stops and What Continues During a Shutdown
- [5:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-20-429-medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown#t=304) Slowed Functions: Pre-submissions, Q-Subs, and Small Business Designations
- [8:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-20-429-medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown#t=533) MDUFA Explained: User Fees, Reserves, and Funding the FDA
- [11:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-20-429-medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown#t=679) Impact on Company Runway and Loss of Interactive Review
- [12:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-20-429-medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown#t=772) Actionable Advice: Improving Submission Quality and Parallel Activities
- [14:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-20-429-medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown#t=888) Managing Investor Communication and Board Expectations
- [19:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-20-429-medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown#t=1184) Industry-Wide Risk Mitigation and Anticipating Political Turmoil

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- FDA (other)
- Nilo Medical Consulting Group (company)
- Medtronic (company)
- PMAs (other)
- 510(k)s (other)
- IDEs (other)
- MDUFA (other)

## Related episodes from other shows

- [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)
- [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)
- [024 - "Operating Under Constraints "with Naveen Agarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal) (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)
- [Closing the gap between Regulatory and Development with Milton Yarberry](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry) (The Pragmatic Embedded Podcast)

## 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/2025-10-20-429-medtech-regulatory-risk-navigating-the-fda-during-a-government-shutdown. 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.