# Everything you Need to Know about SaMD from an FDA Perspective

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-03-01
- Length: 46m
- Episode: 183
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-01-everything-you-need-to-know-about-samd-from-an-fda-perspective
- Listen: https://podcast.greenlight.guru/episode/everything-you-need-to-know-about-samd-from-an-fda-perspective

## Summary

David Pudwill, a former FDA official known as 'Mr. Regulatory', joins host Jon Speer to explain the regulatory landscape for Software as a Medical Device (SaMD). They define SaMD versus Software in a Medical Device (SiMD), discuss risk categorization based on intended use, and outline the FDA's Software Pre-certification Pilot Program. Pudwill advises developers to engage in early pre-submissions (Q-Subs) and utilize FDA guidance documents to navigate the path to clearance.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-01-everything-you-need-to-know-about-samd-from-an-fda-perspective#t=0) Introduction and SaMD Definition
- [9:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-01-everything-you-need-to-know-about-samd-from-an-fda-perspective#t=575) SaMD vs SiMD and Risk Categorization
- [22:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-01-everything-you-need-to-know-about-samd-from-an-fda-perspective#t=1321) Software Pre-certification Pilot Program
- [27:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-01-everything-you-need-to-know-about-samd-from-an-fda-perspective#t=1661) Mobile Medical Applications and Oversight
- [31:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-01-everything-you-need-to-know-about-samd-from-an-fda-perspective#t=1871) Clinical Decision Support and Cyber Hygiene
- [41:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-01-everything-you-need-to-know-about-samd-from-an-fda-perspective#t=2495) Pre-submissions and FDA Engagement Strategy

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- FDA (company)
- IMDRF (company)
- ISO 14971 (other)
- Mr. Regulatory (other)

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- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)
- [134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities) (Let's Combinate)
- [67: Software for Things That Can Kill People](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people) (Embedded.fm)
- [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)
- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (Let's Combinate)

## Citing this page

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