• ReconRecon

    Recon: Pfizer to boost US vaccine deliveries as EU secures more doses; Tango to go public in $353M SPAC deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CDC to weigh rare clot risk with J&J's COVID-19 vaccine as use paused ( Reuters ) ( NYTimes ) Biden officials bracing for possibility of weekslong disruption to J&J vaccine supply ( Politico ) FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots ( Reuters ) Pfizer to deliver 10% more doses to US by end of May- CEO ( Reuters ) Moderna s...
  • ReconRecon

    Recon: J&J delays rollout of vaccine in Europe on news of US pause; India fast tracks emergency approvals of foreign COVID vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US pauses J&J COVID-19 vaccine over rare blood clots ( Reuters ) ( Focus ) ( Politico ) ( NYTimes ) ( FDA ) White House: Johnson & Johnson pause won't have 'significant impact' on vaccination plans ( The Hill ) Reaction after US recommends pause for J&J COVID-19 vaccine ( Reuters ) AstraZeneca shot is good if safety issues can be overcome, US official Fauci sa...
  • Regulatory NewsRegulatory News

    Coalition Calls on FDA to Follow EMA’s Lead and Offer Scientific Opinions on Use of Drugs Outside US

    As part of efforts to streamline and strengthen regulatory pathways for global health products, the Global Health Technologies Coalition (GHTC) says in a new report issued Thursday that Congress should direct the US Food and Drug Administration (FDA) to establish a specific mechanism to offer a formal scientific opinion on medical products for their use outside the US. Because FDA is classified as a stringent regulatory authority, the agency’s review of drugs and devices...
  • Regulatory NewsRegulatory News

    UDI Compliance: What's Coming From FDA in 2016

    Class II medical devices will follow Class III and implanted devices later this year when they come into compliance with unique device identifier (UDI) regulations beginning in September, officials from the US Food and Drug Administration (FDA) told the UDI Conference in Baltimore on Monday. Under the UDI rule, FDA established a phased, risk-based, approach to UDIs, which are tracking tags used to improve the safety of medical devices. The rule began applying to Class II...
  • Regulatory NewsRegulatory News

    FDA Pushes GUDID Compliance Back for Some Devices Due to Security Flaw

    After discovering a security flaw in the Global Unique Device Identification Database (GUDID), the US Food and Drug Administration (FDA) is giving device makers an additional month to comply with new labeling and data submission requirements. Background In 2013, a new set of regulations required companies to comply with new labeling and data submission requirements, with staggered compliance dates based on device classification. Specifically, companies distributing dev...
  • Regulatory NewsRegulatory News

    Russian Regulators Publish New Medical Device Nomenclature System

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Roszdravnadzor, Russia’s medical device market regulator, has published a new system for nomenclature classification according to 19 different device types. The  categories  (link in Russian) appear to be based on Global Medical Device Nomenclature (GMDN), which could suggest that Roszdravnadzor will realign its market registration requir...
  • Feature ArticlesFeature Articles

    US UDI/GUDID Submission Deadlines: What Medical Device Manufacturers Need to Know

    The US Food and Drug Administration (FDA) Unique Device Identification (UDI) final rule, 1 released 24 September 2013, requires medical devices distributed in the US to include a UDI value on the device label and package. The UDI combines a static device identifier, assigned by an FDA-approved issuing agency, and a series of dynamic production identifiers, taken from information on the device’s label. The rule also requires medical device manufacturers to submit ...
  • Regulatory NewsRegulatory News

    FDA Unveils Final Details about Medical Device Tracking System

    Regulators with the US Food and Drug Administration (FDA) have released a second, substantially more complete guidance document indicating how its Global Unique Device Identification Database (GUDID), an integral part of the agency's pending oversight of the Unique Device Identification (UDI) system, works. Background Under FDA's UDI regulation, medical device manufacturers will soon have to start affixing device identifiers and production identifiers to most devi...
  • Regulatory NewsRegulatory News

    FDA Releases Final, Slimmed-Down GUDID Guidance, Leaving Many Details for Later

    The US Food and Drug Administration (FDA) has finalized a guidance document intended to outline the appropriate use of its Global Unique Device Identification Database (GUDID), an integral part of its attempt to overhaul how medical devices are kept track of in the US. But not included in the final guidance is more than half of what the agency originally set out to define. Background A Unique Device Identification (UDI) is, as its name implies, a system of identif...
  • RAPS' LatestRAPS' Latest

    RAPS Taiwan Chapter Becomes First in Asia

    RAPS has announced the establishment of a new chapter in Taiwan, its first in Asia. The RAPS Taiwan Chapter originated as an affiliate. In making the move to become an official chapter, it will be able to offer additional resources and opportunities to the regulatory community in Taiwan. "Regulatory professionals from Taiwan can look forward to local training and networking activities while continuing to access RAPS resources for their professional development and career...
  • RAPS' LatestRAPS' Latest

    RAPS Seeks Authors for Global Device Strategy Book

    Do you have multinational experience with medical devices, throughout the lifecycle, and want to give back to the profession by authoring chapters for a new book? This new publication entitled, Global Strategy for Medical Devices , will help your colleagues develop and implement a strategy to successfully bring their devices to the global stage. To be considered, please submit your interest to Pam Jones by 10 April 2014. Global Strategy for Medical Devices Chapters ...
  • Hamburg: Compounding, Global Regulatory Issues Top Two Upcoming Areas of Regulatory Focus

    Pharmaceutical compounding and global supply chain issues are the two largest regulatory areas of upcoming focus for the US Food and Drug Administration (FDA), Commissioner Margaret Hamburg said in a 2 March 2013 interview with Yale University's The Politic . Compounding Issues Remain In the wide-ranging interview, Hamburg talked about the issues associated with pharmaceutical compounding and a recent outbreak of meningitis several times. In response to a question re...