# What is a Multiple Function Device?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-09-30
- Length: 41m
- Episode: 164
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-30-what-is-a-multiple-function-device
- Listen: https://podcast.greenlight.guru/episode/what-is-a-multiple-function-device

## Summary

Mike Drues from Vascular Sciences explains the regulatory framework for multiple function devices, defined as products containing both regulated medical device functions and non-regulated consumer functions. He analyzes FDA guidance using examples like smartphone skin cancer apps and handheld coagulation devices to show how non-device components are indirectly reviewed through risk mitigation. Drues advises manufacturers to decouple functions for individual risk assessment before evaluating the integrated system, and strongly recommends seeking pre-submission meetings with the FDA to align on strategy.

## Chapters

- [0:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-30-what-is-a-multiple-function-device#t=20) Introduction: Mike Drues and Vascular Sciences
- [1:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-30-what-is-a-multiple-function-device#t=88) Defining Multiple Function Devices and the Cures Act
- [6:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-30-what-is-a-multiple-function-device#t=368) Distinguishing Multiple Function Devices from Combination Products
- [9:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-30-what-is-a-multiple-function-device#t=560) FDA Examples: Smartphone Skin Cancer Apps and Coagulation Devices
- [24:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-30-what-is-a-multiple-function-device#t=1481) Industry Trends and the Blurring Lines of Regulation
- [31:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-30-what-is-a-multiple-function-device#t=1887) Strategic Recommendations: Decoupling and System-Level Risk
- [36:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-30-what-is-a-multiple-function-device#t=2168) The Importance of Pre-Submission Meetings with the FDA

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- CFR (other)
- Cures Act (other)
- FDA (other)
- 510 K (other)
- De Novo (other)
- Apple (company)
- Visualize (product)

## Related episodes from other shows

- [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)
- [099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi) (Let's Combinate)
- [139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-05-139-fda-platform-guidance-ema-q-a-guidance-for-drug-device-combinations-usp-and) (Let's Combinate)
- [152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina) (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/2020-09-30-what-is-a-multiple-function-device. 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.