• Regulatory NewsRegulatory News

    Former FDA Commissioners Make the Case for an Independent Regulatory Agency

    At a plenary session at the American University in Washington, DC four former US Food and Drug Administration (FDA) commissioners argued for FDA to be an independent regulatory agency. The session at a conference jointly hosted by the American University Washington College of Law and the Food and Drug Law Institute on Friday featured former FDA commissioners Robert Califf, Margaret Hamburg, David Kessler and Andrew von Eschenbach. Lewis Grossman, professor of law at the...
  • Regulatory NewsRegulatory News

    FDA Tweaks List of Recognized Consensus Standards for Devices

    A total of about 90 consensus standards used for device premarket reviews and other device regulatory requirements will undergo certain modifications set forth Friday in a notice from the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).   The 14-page notice “will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices,” CDRH said. It includes a list of the modif...
  • Regulatory NewsRegulatory News

    Health Canada Puts Brakes on SaMD Draft Guidance

    A scientific advisory panel on software as a medical device (SaMD) convened in January by Health Canada caused the agency to hit the brakes on a draft guidance document.   The advisory panel, which included the US Food and Drug Administration (FDA), Canada’s medical technology companies (MEDEC), the Council of Canadian Innovators (CCI) and the National Research Council, among others, deliberated on questions Health Canada provided regarding its draft guidance on Sa...
  • Regulatory NewsRegulatory News

    CDRH Issues Final Orders on 6 Medical Device Classifications

    A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.   The final orders cover devices indicated for use in surgery, ophthalmology, anesthesiology and neurology, and classify five new device types into class II (special controls) and one into class I. The classifications were developed based on the de novo classification requests CDRH rece...
  • Regulatory NewsRegulatory News

    EU Releases Working Plan to Implement MDR/IVDR

    The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations (MDR and IVDR). The EC’s working plan describes the legal basis, the expected adoption timelines and the current status of 12 implementing acts under MDR/IVDR and 12 other actions or initiatives. The only implementing act in the roadmap that has been completed so far involves the defined scope of notified body (NB) de...
  • Regulatory NewsRegulatory News

    Cybersecurity: FDA Spells Out Updated Premarket Policies

    With its first guidance in the device space in FY 2019, the US Food and Drug Administration (FDA) unveiled an awaited draft guidance on Wednesday to clarify the agency’s cybersecurity expectations from a premarket perspective. The draft guidance is an update to 2014 premarket policies on cybersecurity and came as the ink was still wet on the memorandum of agreement (MOA) between FDA and the US Department of Homeland Security (DHS) for strengthening a coordinated approac...
  • Regulatory NewsRegulatory News

    CDRH Finalizes Classifications on Herpes Virus IVD, Limb Tremor Stimulator

    In final orders issued Tuesday, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) classified two new device types into class II (special controls).   The two devices are named “herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel” and “external upper limb tremor stimulator.”   Both of the new de novo classifications are intended to “enhance patients’ access to beneficial innovative devices, in part by reduci...
  • Regulatory NewsRegulatory News

    FDA Warns Korean Drugmaker Over Poor Aseptic Practices, Patchy Lab Records

    South Korea-based Hanlim Pharm Co. drew a US Food and Drug Administration (FDA) warning letter over poor aseptic practices and inadequate processes for documentation, among other violations of good manufacturing practice (GMP). The FDA inspection of the company’s drug manufacturing facility in Gyeonggi-do earlier this year concluded that similar GMP violations had been observed during FDA visits to the site in 2014 and 2016. The repeat observations underscore a need for ...
  • Regulatory NewsRegulatory News

    FDA Lists 205 Molecular Targets for Pediatric Cancer Research

     To help with anti-cancer drug development, the US Food and Drug Administration (FDA) has developed two new lists of molecular targets to guide submissions for pediatric study plans.   The two lists, posted Tuesday by FDA’s Oncology Center of Excellence, are aimed at fostering the development of new oncology drugs or biologics for pediatric populations. They also fulfill a commitment the agency made under the FDA Reauthorization Act of 2017 (FDARA).   One list po...
  • Regulatory NewsRegulatory News

    New Law to Boost EU-level Cooperation on Health Tech Assessments

    In a boost for health technology assessments (HTA), the European Parliament recently adopted a new law that allows for greater cooperation among EU member states.   The law on HTAs specifically seeks to minimize duplicate assessments on new medicines and medical devices with the goal of removing unnecessary barriers to patient access and reducing administrative burden on industry. Following its 3 October adoption , the law was well-received by MedTech Europe as ...
  • Regulatory NewsRegulatory News

    EMA Sartan Investigation Flags Aurobindo Pharma, Raises Zhejiang Huahai Oversight

    The European Medicines Agency (EMA) announced Monday low levels of a probable human carcinogen have been detected in a third sartan made the second India-based company—Aurobindo Pharma—to have been linked to the international valsartan scandal.   The notice follows on the heels of the EMA’s decision to extend its review to include medicines containing an additional four sartans, with the one impacted by the suspension of Aurobindo Pharma’s European certificate of s...
  • Regulatory NewsRegulatory News

    CDRH Drafts New Framework to Create a Pediatric Device Safety Network

    A draft framework is in the works at the US Food and Drug Administration (FDA) to create an innovative safety net for pediatric medical devices, Vasum Peiris, Chief Medical Officer for pediatrics and special populations at the Center for Devices and Radiological Health (CDRH), told Focus . The new framework is “centered around the fundamental issue of safety for children,” Peiris said, posing the question “where can we actually innovate safely?” Pediatric academic medic...