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When is UDI required for drug-device combination products?

From the FDA point of view, there are some very nuanced rules about how UDI is applied to combination products. When defining a combination product, 21 CFR 3.2 explains several scenarios. As a ‘single-entity’ combination, two or more regulated components...

FDA Releases Long-Awaited Final Guidance on REMS in SPL Format

In late December 2020, the FDA issued the Final Guidance on REMS (Risk Evaluation and Mitigation Strategy) submissions in Structured Product Labeling (SPL) format. While participation is currently voluntary, and has been since September 2016, compliance with this...

Evolution of UDI: A Look Back at RAPS 2020 Euro Convergence

Reed Tech attended RAPS 2020 Euro Convergence – this year live and online. We were able to connect virtually and share ideas with our colleagues, customers and leading industry experts at our booth, during networking hours and through live sessions. It was great to...

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Medical Device Safety and Quality

Global Data Synchronization Network (GDSN)

UDI and Product Data

Drug  & Biologic Product Submissions

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