The two new final guidances are intended to increase transparency to stakeholders on the FDA’s approach to the issuance and tracking of 522 orders and post-approval study requirements.
On Tuesday, October 4, the White House released a Blueprint for an Artificial Intelligence (AI) Bill of Rights geared toward protecting the American public as the use of AI and machine learning expands throughout industry and online.
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.
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.
