JNPMEDI Distributes Translated Version of FDA Guidelines on Digital Health and Medical Device Clinical Trials

JNPMEDI, a medical data platform company, announced on the 24th of January that it is distributing Korean translations of the U.S. Food and Drug Administration (FDA) guidelines on ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations’ and ‘Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices’.

Each guideline, translated based on the FDA’s publications in December 2023, provides recommendations on the expanded use of digital health technologies and the factors for demonstrating the suitability of Real-World Data (RWD) and Real-World Evidence (RWE) in supporting regulatory decisions concerning medical devices. These translated versions are available for free download on the official JNPMEDI website.

The guideline on ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations’ offers recommendations on the broader use of digital health technologies, based on the draft guidelines released in December 2021. Meanwhile, the guideline on ‘Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices’ details the definitions of RWD and RWE, along with factors and evaluation methods for demonstrating their suitability.

A representative from JNPMEDI’s Global Research Center stated, “Recent advancements in clinical research and drug development, including RWD/RWE, big data, digital healthcare, and decentralized clinical trials, have been accelerating both domestically and internationally.” They further expressed, “We will continue our efforts to promptly share the latest guidelines from global regulatory agencies to facilitate rapid adaptation among domestic companies to global clinical trends, contributing to the advancement of the pharmaceutical and biotech industries.”

Download link: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: https://mvn.do/translations/2024-01-fda-dht

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: https://mvn.do/translations/2024-01-fda-rwe