# Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-12-02
- Length: 31m
- Episode: 170
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-fda
- Listen: https://podcast.greenlight.guru/episode/why-samd-companies-should-be-leveraging-pre-submissions-to-fda

## Summary

Andrew Frink, Regulatory Affairs Manager at Proxima Clinical Research, explains how Software as a Medical Device (SaMD) companies can leverage FDA Pre-Submissions to improve final submission outcomes. He details the specific documentation required for these early interactions, including a clear device description, intended use statement, user interface screenshots, and software architecture diagrams. Frink emphasizes that while full verification and validation plans are not needed upfront, companies must demonstrate a solid understanding of risk management, including FDA's 'level of concern' classification and cybersecurity considerations. The discussion clarifies that agile development is acceptable as long as the process is well-documented and supported by a robust V&V plan.

## Chapters

- [0:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-fda#t=20) Introduction: Andrew Frink and Proxima Clinical Research
- [2:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-fda#t=154) The Purpose and Value of FDA Pre-Submissions
- [9:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-fda#t=578) Core Documentation: Device Description and Intended Use
- [13:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-fda#t=826) User Interface, Screenshots, and Risk Classification
- [17:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-fda#t=1068) Sponsor Read: Proxima CRO and Greenlight Guru
- [20:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-fda#t=1204) Verification, Validation, and Agile Development
- [22:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-fda#t=1371) Software Architecture and Information Flow
- [24:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-fda#t=1493) Cybersecurity and Software of Unknown Pedigree
- [28:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-fda#t=1690) Documents Not Required for Pre-Submissions

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Security & privacy](https://hardwarepodcasts.com/topic/security-and-privacy)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

early-stage companies

## Mentioned

- Proxima Clinical Research (company)
- Greenlight Guru (company)
- FDA (other)
- 510 K (other)
- De Novo (other)
- ISO 14971 (other)
- ISO TIR 24971 (other)
- AWS (company)
- Linux (other)
- Docker (other)

## Related episodes from other shows

- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)
- [How to Speed Up Safety Critical Processes](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes) (The Pragmatic Embedded Podcast)
- [Agile Manifesto Pt. 1](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2022-03-08-agile-manifesto-pt-1) (The Pragmatic Embedded Podcast)
- [Rapid Prototyping for Medical Devices with Ross Dehmoobed](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-01-11-rapid-prototyping-for-medical-devices-with-ross-dehmoobed) (The Pragmatic Embedded Podcast)
- [Living Documentation and Test Automation with Paul Massey](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-15-living-documentation-and-test-automation-with-paul-massey) (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/2020-12-02-why-samd-companies-should-be-leveraging-pre-submissions-to-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.