This article compares real-world evidence (RWE) and postmarket surveillance (PMS) data collected outside of a randomized, controlled, clinical trial. Real-world data (RWD) include individual patient data points such as complaints and anecdotal findings. The recent explosion in RWD collection has led to new challenges in RWD evaluation globally. Solutions are rapidly evolving to analyze these relatively random data points for scientifically valid purposes. This article disc...

Ophthalmic products are regulated under quality standards published in the Code of Federal Regulations (CFR), United States Pharmacopeia (USP), and various US Food and Drug Administration (FDA) guidance. Application of these standards has recently been affected by the legal requirement for the FDA to standardize the regulatory approach to ophthalmic products whose components are considered devices. The agency communicated the update through a guidance outlining the phase-i...

Welcome to the June issue of RF Quarterly in which global regulatory experts write about Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), medical device regulations in China’s National Medical Products Administration (NMPA), and a personal reflection on 3 decades at the International Council for Harmonisation (ICH). Also included are articles on the development of clinical trial disclosure requirements, expedited pathways, and the De Novo pathway and the Final Ru...

This article provides an overview of the regulatory history of the De Novo pathway, from its initial introduction in the Food and Drug Administration Modernization Act (FDAMA) in 1997 to its Final Rule implementation into the US Federal Regulation via 21 CFR 860 in 2022. The authors provide a summary of each of the establishing acts and guidances that have culminated in the regulation, emphasize the historic changes of the process, and provide an analysis of the impact of ...

Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...

The US Food and Drug Administration (FDA) has authorized the first in vitro diagnostic to help diagnose early Alzheimer’s disease. The agency said the test minimizes radiation risks to patients who otherwise would need to be tested with positron emission tomography (PET) scans.   On 4 May, FDA announced it has given the green light to Fujirebio Diagnostics’ de novo application for its Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which is intended for patients ages...

A new analysis from the Duke-Margolis Center for Health Policy outlines the data elements that real-world data (RWD) sources would need to capture in order to evaluate the performance of artificial intelligence (AI)-enabled clinical decision support tools, as well as the ongoing challenges related to data quality, privacy and security.   AI-enabled clinical decision support tools can be difficult to evaluate after deployment because of the non-standardized nature of el...

US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to use the eSTAR filing format at the beginning of 2022. A pilot program for the eSTAR template that kicked off in 2020 began with a template for 510(k) device submissions.   Nine companies participated in that pilot program that trialed the interactive, PDF-based filing format. Use of eSTAR was expanded in September 2020 to include all 5...

The US Food and Drug Administration (FDA) slapped Smiths Medical in Minneapolis, MN with a warning letter for inadequate procedures for handling medical device reports (MDRs), faulty handling of complaints, inadequate validation processes, and lax corrective and preventative actions (CAPA) procedures. The company makes blood warmers and infusion pumps.   The warning letter was issued on 1 October and posted on 23 November. It follows a recent recall of the company’s ...

Hundreds of thousands of complaints from users of Philips Respironics’ breathing assistance devices have been inadequately addressed by the firm, according to recent information released by the US Food and Drug Administration (FDA). The release of an inspection report and FDA’s accompanying statement provides more detail on what Philips knew, and what the firm did – or did not do – to remedy known problems with degradation of foam components in its breathing devices.   ...

The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about the documentation needed to support the agency’s evaluation of device software functions for premarket submissions.   The agency said the guidance recognizes the “rapidly evolving nature of digital health and recent FDA recognized consensus standards related to software” and, when finalized, will serve as an update to the Guidance for the Content of Premark...

The US Food and Drug Administration (FDA) on Monday issued a final rule setting requirements for the medical device de novo classification process, codifying procedures and criteria for new types of medical devices to be authorized as Class I or Class II devices.   "These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation. They are also i...