• Regulatory NewsRegulatory News

    New MDCG guidance shows how devices fit into MDR’s classification rules

    The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are placed on the EU market.   Under the MDR , which went into effect on 26 May 2021, devices are divided into four classes: I, IIa, IIb and III. Devices are ranked according to risk from class I for the lowest-risk devices to class III for the highest.  Annex VIII of the...
  • RAPS' LatestRAPS' Latest
    RAPS AnnouncementsRAPS Announcements

    RAPS updates website with new look, more intuitive navigation

    RAPS has redesigned its website, updating it with new navigation and features to help make it easier to find exactly what you are looking for. New homepage The first thing you will likely see when visiting RAPS.org is the refreshed, new-look homepage. We have added five prominent navigation blocks right on the homepage, linking you to RAPS’ most sought after content—news, membership information, education offerings, certification information and resources. We also ha...
  • RoundupsRoundups

    FDA Approvals Roundup: Livmarli and Tecartus

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Livmarli approved for cholestatic pruritus in children with Alagille syndrome Mirum’s Livmarli (maralixibat oral solution) has been approved for treating cholestatic pruritus in patients aged 1 year or older who have Alagille syndrome (ALGS).   ALGS is a rare genetic disorder caused by abnormalities in bile ducts that can lead to progressive ...
  • ReconRecon

    Recon: Pfizer, Voyager sign $630M gene therapy deal; WHO backs malaria vaccine for children in Africa

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Polarean Imaging says FDA rejects new drug application, shares slump ( Reuters ) FDA center directors on lessons from the EUA pathway: Flexibility serves us well ( Endpoints ) Troubled Voyager’s gene therapy relaunch gets a boost with $630M Pfizer deal ( Endpoints ) FDA offers support for Takeda's potential cytomegalovirus drug ahead of adcomm ( Endpoints ) A...
  • Regulatory NewsRegulatory News

    New guide to clinical trial lay summaries available for EU sponsors

    The European Commission (EC) has laid out recommendations on best practices for preparation, translation and dissemination of lay summaries of clinical trial information, intended both for trial participants and the general public, in a newly published document.   The EC’s Clinical Trials Expert Group (CTEG) adopted the guidelines in July 2021; the 85-page document walks users through the lay summary (LS) process from the planning and scoping stage, through the develop...
  • Regulatory NewsRegulatory News

    FDA finalizes long delayed de novo classification rule

    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...
  • RoundupsRoundups

    Asia-Pacific Roundup: China’s NMPA applies for pre-accession to PIC/S

    China’s National Medical Products Administration (NMPA) has applied for “pre-accession” to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The voluntary step is intended to identify gaps between PIC/S membership requirements and the system used by the regulatory agency.   PIC/S held a bilateral meeting with NMPA late in 2019 to discuss issues raised by the Chinese drug regulatory agency in relation to a possible future application or pre-application. Almos...
  • ReconRecon

    Recon: AstraZeneca seeks EUA for preventative COVID antibody; EMA considers rolling review for Merck's COVID drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer/BioNTech COVID-19 vaccine effectiveness drops after 6 months, study shows ( Reuters ) J&J files for authorization of COVID-19 vaccine booster ( Reuters ) AstraZeneca Submits Preventive Covid-19 Treatment for FDA Authorization ( WSJ ) ( Reuters ) Pharmacy chains failed to prevent opioid misuse, U.S. jury hears ( Reuters ) Henrietta Lacks' estate says ph...
  • RF Quarterly

    RF Quarterly, October 2021: Quality and compliance

    Welcome to the fall issue of RF Quarterly in which international experts from the US, EU, and Saudi Arabia examine quality and compliance and their governing regulations, with specific focus on data integrity, quality system design and management, current good manufacturing practice (cGMP), and postmarketing activities in relation to medical devices, pharmaceuticals, and biologics.   Pragmatism, integrity, and QMS Data reliability in all formats and parts of an o...
  • RF Quarterly

    Data integrity and compliance with GxP: A pragmatic approach

    Issues related to data integrity have been in the news in recent years, often focusing on companies receiving citations from regulatory agencies regarding unreliable computer data. While the laboratory and computer data were the primary focus, data reliability in all formats and in all parts of the operation are critical to ensure products are reliable. While many also think this issue applies only to quality and operations, if the information listed in the regulatory doss...
  • RF Quarterly

    Current good manufacturing practices and quality system design

    Quality by design, or the principle of building quality into a product and testing, was introduced in 2011 as process validation guidance. Today it is codified within the Title 21 section 820. The quality management system (QMS) encompasses this principle in all areas of healthcare manufacturing – including drugs, biologics, and devices – and, with compliance, can ensure the safety and effectiveness of all manufactured products. The establishment, implementation, and maint...
  • RF Quarterly

    Medical device quality management systems

    Introduction A quality management system (QMS) is one of the five medical device conformity assessment elements. 1 Manufacturers of medical devices are expected to implement, document, and maintain a QMS that “ensures the medical devices it designs, manufactures, and supplies to the market are safe, perform as intended, and comply with the relevant provisions of the regulations in the countries where the product is made available.” 2   Today, a QMS is seen as a ...