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  • Regulatory NewsRegulatory News

    FDA issues final guidance on multiple function device products

    A finalized guidance gives direction for sponsors on US Food and Drug Administration (FDA) review of medical products that contain both medical and non-medical functions.   The guidance addresses provisions of the 21 st Century Cures Act ( Cures Act) that excluded some software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new document follows an April 2018 draft guidance and clarifies just how – an...
  • Feature ArticlesFeature Articles

    Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers

    This article examines regulatory considerations for emergency use authorizations for medical device manufacturers in response to the COVID-19 pandemic. The authors summarize the four phases of issuance as:  phase 1 ‒ in vitro diagnostic products; phase 2 ‒ personal protective equipment; phase 3 ‒ ventilators and components; and phase 4 ‒ other relevant medical devices. They emphasize the EUA is subject to statutory limits tied to the end of the public health emergency and ...
  • Regulatory NewsRegulatory News

    WHO issues guidance for prequalified products amid COVID-19

    The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract research organizations taking part in the agency's prequalifications programs. Localized adjustments in processes and procedures may be necessary for manufacturing, clinical trial and testing organizations due to the coronavirus pandemic, but should aim to minimize the risk of ...
  • FDA warns breast implant manufacturers

    The US Food and Drug Administration (FDA) today issued warning letters to two breast implant manufacturers, Allergan and Ideal Implant. Each company was cited for different deficiencies. "The FDA's actions today are part of the agency's ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices," FDA officials said in a statement. "The FDA remains committed to thoughtful, scientific, transparent, public dialogue conc...
  • Regulatory NewsRegulatory News

    FDA creates umbrella emergency pathway for COVID-19 serology tests

    The US Food and Drug Administration (FDA) has created a new pathway to support the emergency authorization of tests for antibodies of the virus that causes COVID-19.   Serology tests could play an important role in the safe lifting of lockdowns by enabling authorities to identify individuals with antibodies of the SARS-CoV-2 virus and calculate what proportion of a population has already been infected. The pathway unveiled by FDA on Wednesday gives test developers a ne...
  • Regulatory NewsRegulatory News

    FDA lifts requirements for fever screening devices

    Telethermographic devices originally intended for industrial, construction and commercial use can be repurposed to assist in initial screening for fever and triage of individuals in high traffic areas such as airports and businesses under guidance issued by the US Food and Drug Administration (FDA). The guidance was issued for the duration of the public health emergency related to coronavirus disease (COVID-19). “The guidance may help address urgent public health con...
  • Regulatory NewsRegulatory News

    FDA eases entry for psychiatry apps during COVID-19 crisis

    To address mental health needs during the coronavirus disease (COVID-19) public health emergency, the US Food and Drug Administration (FDA) today announced it would relax certain premarket requirements for computer programs and mobile apps designed to support treatment of conditions such as depression, anxiety, obsessive compulsive disorder and insomnia. The guidance addresses Class II prescription-only devices and computer programs that support clinician-supervised out...
  • Regulatory NewsRegulatory News

    FDA grants first EUA for blood purification device for COVID-19 patients

    The US Food and Drug Administration (FDA) on Friday granted its first emergency use authorization (EUA) for a blood purification system to treat patients at risk for respiratory failure due to coronavirus disease (COVID-19).   The EUA was granted to Terumo BCT Inc. and Marker Therapeutics authorizing the use of their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices to filter cytokines and other inflammatory proteins from patients’ blood.  ...
  • Regulatory NewsRegulatory News

    FDA issues 2nd EUA for decontamination system for N95 masks

    The US Food and Drug Administration on Friday issued a second emergency use authorization (EUA) to help decontaminate N95 or N95-equivalent respirator masks so they can be reused by health care workers in hospitals. FDA said this EUA, issued to Steris Corporation for a system that uses vaporized hydrogen peroxide, will support the decontamination of about 750,000 N95 respirators per day in the US. The EUA comes as shortages of the masks have pushed some hospitals to...
  • Regulatory NewsRegulatory News

    MDCG explains when devices can be exempt from premarket clinical consultations

    The Medical Device Coordination Group (MDCG) recently updated its guidance on interpreting Article 54(2)b of the Medical Devices Regulation (MDR), which discusses the criteria that exempt devices from the premarket clinical evaluation consultation procedure with expert panels. According to the text of the article, the clinical evaluation consultation procedure shall not been required when: (a) a firm is renewing certificate under MDR; (b) a device “has been design...
  • Regulatory NewsRegulatory News

    Notified body audits during the pandemic: New MDCG guidance

    The Medical Device Coordination Group (MDCG) on Wednesday issued guidance to help notified bodies perform audits during the pandemic, including, under certain circumstances, remote audits. The 5-page guidance deals strictly with surveillance audits under the medical devices directives, audits conducted for recertification purposes under the directives, in cases where a manufacturer submits a change notification to a notified body that would typically require an on-site ...
  • Feature ArticlesFeature Articles

    Eudamed’s delay and its impact on clinical investigations under the EU MDR

    This article reviews possible ramifications caused by the delay in launching the European Union’s new electronic database, the European Database on Medical Devices (Eudamed).The author discusses potential issues when clinical investigation data is not transparent or accessible. Until Eudamed is available, posting study results on other databases is recommended so manufacturers can meet requirements for clinical investigation transparency and disclosure while sharing clinic...