• Regulatory NewsRegulatory News

    This Week at FDA: CDRH and Endologix leaks, OTC monograph reform, and more

    Welcome to Week 2 of This Week at FDA . We've again gathered the week’s news from (and about) FDA. Each Friday, we'll be covering agency activities and enforcement actions, filings in the  Federal Register , new guidances, legislative updates, and anything else we come across – all in one place. We hope you will find it to be your one-stop shop for FDA updates. What do you think? We’d be happy to hear your feedback at news@raps.org. The House Committee on Oversight ...
  • Regulatory NewsRegulatory News

    This Week at FDA: New proposed rules, Biocon's Form 483, and more

    We're trying something new at Regulatory Focus , with the goal of gathering the week’s news from (and about) FDA. We'll be covering agency activities and enforcement actions, filings in the Federal Register , new guidances, legislative updates, and anything else we come across – all in one place. We hope you will find it to be your one-stop-shop for FDA updates. What do you think? We’d be happy to hear your feedback at news@raps.org. News from this week One of t...
  • Regulatory NewsRegulatory News

    FDA issues draft guidance for device software in premarket submissions

    The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about the documentation needed to support the agency’s evaluation of device software functions for premarket submissions.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...
  • Feature ArticlesFeature Articles

    October’s Regulatory Focus: Linguistic review, advanced therapies in Asia-Pacific, and more

    Feature articles during October included an in-depth look at the linguistic review process in Europe and  reviews of the regulatory pathways for herbal medicinal products, medical devices, and supplements in the EU and for advanced therapies in the Asian-Pacific region. Also included was an article on the challenges of data integrity remediation in cGMP facilities.   Linguistic review and herbal product regulation The linguistic review process for centrally authori...
  • Regulatory NewsRegulatory News

    Wound dressing firm warned for design, environmental control issues

    An Ohio firm that is both an own-label distributor and specification developer of sterile wound dressings received a warning letter from the US Food and Drug Administration (FDA) for ongoing problems including a lack of medical device reporting procedures, design control issues, and lack of document and environmental control, among others.   CellEra LLC, which distributes wound dressings with drugs such as silver, petrolatum and collagen, received the 20 October warnin...
  • Feature ArticlesFeature Articles

    EU regulation of herbal products, Part 1: Definitions, regulations, and documentation

    This article compares and contrasts the regulatory requirements for herbal medicinal products, herbal-based medical devices, and botanical food supplements in the EU. It provides an overview of the current framework, highlights areas of controversy, and presents recent regulatory developments. The article is the first of two on this topic. The current article presents the definitions, main regulations, and documentation requirements for placing the products on the market;...
  • Regulatory NewsRegulatory News

    FDA issues proposed OTC hearing aid rule

    The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale of over-the-counter (OTC) hearing aids for adults with mild and moderate hearing loss.   Implementing the proposed rule would make good on requirements established by the Over-the-Counter Hearing Aid Act of 2017 passed as a provision of the FDA Reauthorization Act of 2017 . The act directed FDA to create a report available f...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

    TGA releases guide to classifying active medical devices by risk   New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.   The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU w...
  • ReconRecon

    Recon: CureVac pulls back its COVID mRNA vax; Medtronic's new robotics bid

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency ( FDA ) FDA still without a permanent leader as clock ticks down on acting head ( CNN ) IPO floodgates open up after summer lull as five more biotechs file for Nasdaq ( Endpoints ) FDA staff doesn’t take stance on Moderna Covid booster shots, says two doses are...
  • 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 ...
  • RF Quarterly

    Medical device compliance and postmarketing activities

    This article provides an overview of medical device postmarketing requirements. These requirements include, but are not limited to, establishment registration, medical device reporting, and device tracking. Additional requirements include postmarket surveillance studies required under Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 522 and postapproval studies required at the time of approval of certain application types.   Introduction: Establishment registra...
  • RF Quarterly

    PMS and the role of CAPA in the medical device regulatory cycle: A Saudi perspective

    It is important for both medical device manufacturers and regulators to establish robust postmarketing surveillance (PMS) of devices to ensure their continued safe use. The PMS system should include reactive and proactive components, that is, vigilance and safety signals assessments. Applying corrective and preventive actions (CAPAs) as a part of the quality management system improves the quality and safety aspects of the manufactured medical devices. This article examines...