Hardware Podcasts

094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young

Let's Combinate · 19 Jul 2023 · 36m

What this episode covers

Rumi Young, Director of Regulatory Policy at Becton Dickinson (BD), discusses the regulatory challenges of smart connected combination products, such as insulin pens and on-body injectors, which integrate sensors, apps, and AI/ML. She explains how unit-level traceability using RFID can optimize manufacturing and clinical trials, while highlighting the current regulatory silos at the FDA that hinder consistent policy for these cross-therapeutic technologies. Young advocates for a single source of truth within the FDA to streamline the use of tools like comparability protocols and predetermined change control for post-market algorithm updates.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Becton Dickinson, FDA, CDRH, CDE
Products
iPhone, Insulin pens, On-body injectors, Autoinjectors, Infusion pumps, Syringes
Tools
RFID
Also
510 K, PMA, BLA

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