RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    CDRH Seeks to Exempt Certain Flow Cytometers from 510(k) Reviews

    The US Food and Drug Administration (FDA) issued a proposed order Tuesday to exempt certain flow cytometer instruments from 510(k) requirements. The flow cytometer instruments are currently regulated by the agency as class II devices, which are subject to 510(k) reviews. But FDA’s Center for Devices and Radiological Health (CDRH) has determined premarket notification is no longer necessary to provide reasonable assurance of safety and effectiveness prior to market entry...
  • Regulatory NewsRegulatory News

    European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs

    The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption. Background In the EU, SPCs, which apply to innovative pharmaceutical and plant protection products and have been increasingly used sinc...
  • Regulatory NewsRegulatory News

    FDA Amends Humanitarian Device Exemption Regulations

    The US Food and Drug Administration (FDA) on Tuesday announced that it is amending its regulations governing humanitarian device exemptions (HDE) to reflect changes brought on by the 21st Century Cures Act . These exemptions provide a pathway for device makers looking to develop medical devices for small patient populations by exempting them from demonstrating a device's effectiveness. Instead, a company must demonstrate that the humanitarian use device (HUD) "will no...
  • Regulatory NewsRegulatory News

    FDA Signs Off on New Device to Treat Esophageal Birth Defect in Babies

    The US Food and Drug Administration (FDA) on Friday authorized the use of a first-of-its-kind medical device to treat infants up to one year old for a rare birth defect that causes a gap in the esophagus. The device, Cook Medical’s Flourish Pediatric Esophageal Atresia Anastomosis, was authorized via the humanitarian device exemption (HDE) process as an estimated 1 in every 2,500 babies in the US is born with the condition, known as esophageal atresia. "This new...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Benefit-Risk Considerations for IDEs

    The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing its framework for assessing the benefits and risks of investigational device exemptions (IDEs). "A primary goal of this guidance is to clarify the factors that FDA considers when assessing risks and anticipated benefits for IDE studies, and how uncertainty may be offset by a variety of risk mitigation measures that can ensure appropriate patient and participant protections in investiga...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Neurological Device Trials

    The US Food and Drug Administration (FDA) on Friday finalized its guidance for sponsors looking to submit an investigational device exemption (IDE) to conduct clinical trials for neurological devices targeting disease progression in diseases such as Alzheimer's and Parkinson's. "FDA believes that neurological devices intended to slow disease progression and improve clinical outcomes that are meaningful to patients may represent a revolutionary option for patients," FDA w...
  • Regulatory NewsRegulatory News

    FDA Draft Guidance to Assist CMS With IDE Coverage Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to take effect between FDA and the Centers for Medicare and Medicaid Services (CMS). While an agreement has been in place between the two agencies for more than two decades, FDA says it has run into issues with some devices not easily fittin...
  • Regulatory NewsRegulatory News

    CDRH Develops 'Regulatory Toolkit' to Promote Device Innovation

    Officials from the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) say their efforts to develop a "regulatory toolkit" for sponsors has helped promote medical device innovation in the US, according to a recent viewpoint in JAMA Ophthalmology . While fostering innovation has been one of CDRH's strategic priorities since 2010, reports that growth in device clinical trials in the US had fallen behind other countries, including Braz...
  • Regulatory NewsRegulatory News

    TGA to Migrate Clinical Trial Applications to New Online System

    The Therapeutic Goods Administration (TGA) will begin migrating clinical trial forms from a paper-based system to a new online system later this month. Background To conduct a clinical trial in Australia on an unapproved product, or for an unapproved use of a product, a company must either submit a clinical trial notification (CTN) or a Clinical Trial Exemption (CTX) . The vast majority of clinical trials conducted in Australia follow the CTN scheme, which requires th...
  • Regulatory NewsRegulatory News

    FDA Isn't Waiting Around for 'Cures' to Speed Access to Devices

    While the Congress is busy working on the 21st Century Cures Act , which is expected to speed access to new drugs and devices, a new report from EP Vantage shows FDA isn't sitting on its hands. 2015: A Record Year for Device Approvals? In the first half of 2015, FDA has already cleared 26 devices with either premarket approval (PMA) or a humanitarian device exemption (HDE). To put that in perspective, in half a year FDA has already granted more PMAs and HDEs to new ...
  • Regulatory NewsRegulatory News

    FDA Exempts 120 Medical Device Types from Most Regulation

    The US Food and Drug Administration (FDA) plans to exempt 120 medical device classes from its premarket notification and review requirements, making it substantially easier for companies to market the devices. Background Under existing regulations, FDA regulates devices according to three general categories: Class III – High-risk devices; require the submission of a Premarket Application (PMA). Class II – Moderate-risk devices; require the submission of a Premarket N...
  • Regulatory NewsRegulatory News

    In Fight Against Ebola, Device Company Seeks FDA Approval Through Rarely Used Pathway

    In the battle against the Ebola virus, perhaps no weapons have been as sought after as new treatments and diagnostic products to help keep the virus in check and patients safe from harm. But since the start of the outbreak in 2014, one regulatory standard has been an elusive goal for these medical products: Approval. To date, no product has received the full approval of the US Food and Drug Administration (FDA). Now one company is hoping to change that. Seeking Approval ...