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  • Regulatory NewsRegulatory News

    Study calls for proactive surveillance of device AEs

    The US Food and Drug Administration (FDA) relies mainly on direct reports and regulator-initiated surveillance to flag safety concerns around medical devices, a system that may delay detection of adverse events (AEs), according to a new analysis published in JAMA Internal Medicine . “These data highlight the importance of proactive identification of postmarketing device-related safety issues to provide health care professionals with more complete data regarding potenti...
  • Regulatory NewsRegulatory News

    Breast implant label guidance finalized by FDA

    Updated 29 September to add comment from CDRH official The US Food and Drug Administration (FDA) issued final guidance on improving patient information regarding breast implants on 28 September. The final guidance largely echoes draft labeling guidance issued in October 2019, with some clarifications surrounding the relationship between implants and systemic disease, language to improve the readability of the patient device card, and information on specific registries...
  • Regulatory NewsRegulatory News

    FDA updates Pre-Cert pilot for SaMD

    Lessons learned from a digital health software pilot pre-certification program have readied the US Food and Drug Administration (FDA) to test an updated version of the continuous evaluation program for developers of software as a medical device (SaMD).   The precertification (Pre-Cert) pilot “will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices,” said FDA in...
  • Feature ArticlesFeature Articles

    Current Chinese NMPA clinical pathways for medical device registration

    This article presents the key highlights of the current clinical pathways for registering medical devices in China and discusses when the various clinical pathways should be used, based on the country's National Medical Products Administration (NMPA) regulations and guidances. Introduction The NMPA, 1 formerly known as the China Food and Drug Administration, is the Chinese agency responsible for regulating drugs and medical devices. In addition to the national NMPA, ...
  • Regulatory NewsRegulatory News

    FDA qualifies decision tool for breast reconstruction studies

    The BREAST-Q Reconstruction Module now is qualified as a medical device development tool (MDDT) to aid sponsors and investigators in developing feasibility, pivotal and post-approval studies of medical devices used in breast reconstruction, the US Food and Drug Administration (FDA) announced. “An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making,” according to the announcement , which noted its ...
  • 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...