The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
The order outlines a “whole-of-government approach” to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience and national and economic security.
Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.
Peter O’Blenis, CEO of Evidence Partners, discusses the growing role—and challenges –of literature reviews in the medtech market.
“We are excited that organizations like Innovaccer are working to improve trust in clinical data and help ensure the data’s accuracy and broader usability.”
Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use.
Gain insight into the notified body approach to assessing biological equivalence and how manufacturers can make sure their equivalence justifications pass notified body review.
The final rule from the FDA establishes a new category of over-the-counter hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers.
The Experiential Learning Program (ELP) provides CDRH review staff with an opportunity to visit sites and gain a better understanding of the products they review. The 2023 ELP Site Visit Proposal period is open now until September 6, 2022.
Before product developers can more confidently design RWE studies and venture away from the traditional path of lengthy prospective studies, industry must overcome several challenges. This article provides insight on these barriers and perspective on how industry might fully realize the promise of RWE in the near-term to advance health care.
