# Why the PMA Process is so Dreaded by Manufacturers in the US Market

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-03-25
- Length: 46m
- Episode: 187
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-25-why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market
- Listen: https://podcast.greenlight.guru/episode/why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market

## Summary

David Pudwill, known as Mr. Regulatory, explains why the FDA's Premarket Approval (PMA) pathway for Class III medical devices is feared by manufacturers due to its high cost, long timelines, and uncertainty. He contrasts the PMA process with 510(k) and De Novo pathways, highlighting that PMAs require substantial clinical data and carry significant user fees, such as $366,000 for original submissions. Pudwill advises companies to consider strategic alternatives, such as using lower-risk classifications for initial revenue generation or leveraging the Pre-Submission program to engage with the FDA early in development.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-25-why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market#t=0) Introduction: David Pudwill and the PMA Fear
- [2:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-25-why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market#t=127) Why Manufacturers Dread PMA: Time, Cost, and Uncertainty
- [7:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-25-why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market#t=439) Reimbursement Challenges and FDA-CMS Collaboration
- [11:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-25-why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market#t=669) Strategic Pathways: 510(k) vs. PMA and Biliary Stents
- [16:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-25-why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market#t=1019) Historical Context and Definition of PMA Devices
- [23:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-25-why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market#t=1436) The PMA Process: Pre-Submissions, IDEs, and Modular PMAs
- [36:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-25-why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market#t=2187) PMA User Fees and Supplement Costs
- [42:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-25-why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market#t=2573) Key Takeaways and Resources for Manufacturers

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- FDA (other)
- CMS (other)
- Green Light Guru (company)
- Mr. Regulatory (other)

## Related episodes from other shows

- [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)
- [027 - "Become a Historian of the Problem" with Duane Mancini](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini) (Let's Combinate)
- [064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with) (Let's Combinate)
- [118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su) (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/2021-03-25-why-the-pma-process-is-so-dreaded-by-manufacturers-in-the-us-market. 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.