RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    CDRH Drafts Guidance on Mouse Embryo Assays

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday called for comments on draft guidance to aid sponsors in conducting the mouse embryo assay (MEA) in support of premarket submissions and lot release of assisted reproduction technology (ART) devices. Although there are no voluntary consensus standards on how to conduct the MEA, CDRH said the MEA is “a commonly used test to assess whether an assisted reproduction te...
  • Regulatory NewsRegulatory News

    EU MDR: Germany and Ireland Express Concerns

    German and Irish delegations to the Council of the European Union recently raised concerns with notified body (NB) capacity and the implementation of the EU’s medical device regulation (MDR). Ahead of a 14 June Council session, the delegations explain how NB capacity “is the most imminent and high-profile challenge,” although system requirements, infrastructure and secondary legislation are additional challenges. And although the European Commission remains steadfast...
  • Regulatory NewsRegulatory News

    Industry Groups Question Aspects of CDRH’s AI/ML-Based SaMD Framework

    Feedback on the US Food and Drug Administration’s (FDA) proposed regulatory framework for artificial intelligence- (AI) and machine learning- (ML) based software as a medical device (SaMD) underscores the uncertain environment for developing such products. The comment period on a discussion paper that proposed the framework in April closed last week with more than 100 comments, most of which were made public on Friday. Many commenters tout the efforts of the FDA’s Cen...
  • Regulatory NewsRegulatory News

    FDA to Explore Randomized Trials Using RWE for Regulatory Purposes

    The US Food and Drug Administration (FDA) said Friday it will host a 2-day public workshop on leveraging randomized clinical trials to generate real-world evidence (RWE) for regulatory decisions. The Duke-Margolis Health Policy Center will convene the workshop under a cooperative agreement with FDA to explore how randomized clinical trial designs, including those that incorporate pragmatic design elements, can use real-world data (RWD) to generate RWE in clinical settin...
  • Regulatory NewsRegulatory News

    EU MDR: COCIR Offers Recommendations on Notified Bodies, Grace Period

    The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued new recommendations on the availability and capacity of notified bodies (NBs) and the sustainability of the grace period under the European Union’s (EU) medical device regulation (MDR). The recommendations, detailed in a position paper released Thursday, address challenges with the ongoing lack of NBs designated under MDR and confusion regarding the regulati...
  • Regulatory NewsRegulatory News

    CDER Drafts Drug Development Guidance on NASH With Compensated Cirrhosis

    The Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) issued draft recommendations for sponsors looking to develop drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. NASH is associated with a range of common diseases, including type 2 diabetes, hypertension and obesity, among others. “It is a growing public health concern and is anticipated to be the leading cause of liver transplantation within a dec...
  • Regulatory NewsRegulatory News

    EU MDR/IVDR Coordination Group Answers Questions About Notified Bodies

    The European Commission (EC) issued a Q&A document on Thursday to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs). The 8-page document endorsed by the Medical Device Coordination Group (MDCG) answers four sets of questions on a range of MDR/IVDR requirements relating to NBs. The clarifications cover organizational and general requirements, as well as resources requirements and process requ...
  • Regulatory NewsRegulatory News

    NESTcc Taps Apple Watch as First Wearable Project

    The National Evaluation System for health Technology Coordinating Center’s (NESTcc) 12 new real-world evidence (RWE) test cases marked its first active surveillance project—the US Food and Drug Administration’s (FDA) test case on synthetic mesh slings—and the first test case to involve a wearable, with the Apple Watch. New in NESTcc’s portfolio is also the first research question submitted by a patient advocacy organization. Projects that will include patient-generated ...
  • Regulatory NewsRegulatory News

    FDA Wins Federal Court Case Against Stem Cell Clinics

    A federal court on Monday ruled in favor of the US Food and Drug Administration (FDA) in a case over whether unapproved stem cell products can be considered adulterated and misbranded. US District Judge Ursula Ungaro of the Southern District of Florida ruled that stromal vascular fraction (SVF) cells can be a drug and subject to the Federal Food, Drug, and Cosmetic Act ’s (FDCA) adulteration and misbranding provisions. US Stem Cell Clinic LLC of Weston, FL and US Stem ...
  • Regulatory NewsRegulatory News

    Combination Products and MDR: EMA Offers New Draft Guideline

    With a focus on drug-device combination products, the European Medicines Agency (EMA) on Monday issued its second draft guideline as part of a series related to the EU’s medical device regulation (MDR). The draft guideline covers the documentation expected for drug-device combinations (DDCs) in the quality part of the dossier for a marketing authorisation application (MAA). DDCs falling within the scope of this guideline are medical devices that are integral to the medi...
  • Regulatory NewsRegulatory News

    FDA’s First Hearing on CBD Opens a Path to Regulation

    The US Food and Drug Administration (FDA) held its first-ever public hearing Friday on products containing cannabis and cannabis-derived products, with advocates and critics calling for an efficient regulatory framework. FDA officials, including co-chairs of the agency’s internal working group on cannabidiol (CBD), FDA principal associate commissioner for policy Lowell Schiller and principal deputy commissioner Amy Abernethy, heard from nearly 100 hearing participants b...
  • Regulatory NewsRegulatory News

    Spanish NB Adds More Uncertainty Ahead of EU MDR

    The Spanish notified body (NB) said Thursday it will no longer accept new medical device applications from new clients for CE marking per 92/42/EEC beginning 1 June 2019 and cease to process new certificate applications from existing clients from 31 July 2019. The Spanish Agency of Medicines and Medical Products (AEMPS), acting as NB 0318 under the EU’s medical device directive, did not offer any concrete explanation for its decision to retire CE marking operations. It ...