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  • Regulatory NewsRegulatory News

    FDA expands eSTAR filing to de novo devices, IVDs

    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...
  • ReconRecon

    Recon: Blueprint's $250M preclinical buy; WHO, CDC, Biden react to Omicron variant

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says omicron variant is cause for concern but not panic ( NPR ) CDC Statement on B.1.1.529 (Omicron variant) ( CDC ) Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback ( Fierce ) Opinion: Becerra needs to open up to the press ( AHCJ ) Opinion: Will Moderna Ever Learn to Share? ( MedPage Today ) Who ...
  • Regulatory NewsRegulatory News

    Smiths Medical warned by FDA for multiple violations

    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 ...
  • Regulatory NewsRegulatory News

    This Week at FDA: mRNA boosters for most; Blood lancets reclassified

    Welcome to our weekly digest of regulatory news from the US Food and Drug Administration (FDA), legislative updates, and other news updates we think you’ll find useful — and interesting. This week saw COVID-19 vaccine and therapy updates, the unveiling of Cures 2.0 , and lots of device updates. As usual, we welcome feedback at news@raps.org .    Friday morning, the US Food and Drug Administration (FDA) announced an expansion of the emergency use authorizations (EUA...
  • Regulatory NewsRegulatory News

    Industry, clinician groups have different wish lists for AI/ML-enabled device labels

    Medical device industry groups are urging the U.S. Food and Drug Administration (FDA) not to rush to create new regulatory requirements around the labeling of medical devices that incorporate artificial intelligence or machine learning (AI/ML), while clinician groups are seeking greater transparency about device algorithms and training data sets.     In total, 15 groups offered comments following a virtual public workshop held by FDA on the transparency of AI/ML-enable...
  • Regulatory NewsRegulatory News

    FDA inspection turns up more problems for Philips Respironics

    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.   ...
  • 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...
  • 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...
  • 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...