The goal of the TAP Pilot is to reduce the time from concept to commercialization of medical devices by facilitating robust engagement early in the process with the FDA, industry and key stakeholders.
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.
One of the biggest stumbling blocks for manufacturers, particularly those with legacy devices, is clinical evidence under IVDR. Carlos Galamba, former technical reviewer and current VP of Intelligence and Innovation at RQM+, discusses the challenges and opportunities of the more stringent evidence requirements facing diagnostics developers.
The competition will explore the feasibility, resources and infrastructure needed to integrate real-world healthcare system data into AHRQ’s systematic review findings to improve healthcare practice. The top award winner could earn up to $200,000.
The guidance seeks to balance the need to obtain data on the safety and effectiveness of drugs, biological products and medical devices in the pediatric population with risks associated with exposure to such products and the reality that children cannot themselves consent to take part in research.
The deeper insights provided by a single source of truth help regulatory teams pinpoint and address gaps in data collection during each trial phase. By mitigating potential risks earlier in the process, teams generate more robust evidence and stronger submissions, which often means a shorter approval process.
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.
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.
Taking these compliance challenges into account will allow healthcare organizations to prepare for compliance audits, but more importantly it will help institutions address issues that result in a negative patient outcome.
