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  • Regulatory NewsRegulatory News

    CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions

    The US Food and Drug Administration (FDA) on Monday published final guidance on the FD&C Act’s least burdensome provisions for the regulation of medical devices, highlighting recent initiatives via newly added themes. The 24-page document, which finalizes a draft from December 2017, is intended to reflect guiding principles that require “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient...
  • 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    FDA Draft Guidance to Assist CMS With IDE Coverage Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to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

    How do you Weigh Benefits and Risks in Medical Device Trials? FDA Guidance Explains

    Which factors should medical device manufacturers take into account when trying to determine whether an investigational device is suitable to begin testing in humans? The US Food and Drug Administration (FDA) has some thoughts on the matter, contained within a new draft guidance document released on 17 June 2015. Background The guidance, Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs) , relates t...
  • Regulatory NewsRegulatory News

    FDA Touts Major Improvements in Clinical Trial Approval Times for Medical Devices

    The US Food and Drug Administration's (FDA) medical device regulator, the Center for Devices and Radiological Health (CDRH), is touting huge improvements to the speed at which it is managing to approve new proposals to start research involving investigational medical devices. Background The news, contained in a report issued by CDRH this week, focuses in part on the Investigational Device Exemption (IDE) process. An IDE is essentially a request to exempt a device from f...
  • Regulatory NewsRegulatory News

    FDA Guidance Shelves Plan Intended to Help Accelerate Clinical Research on Medical Devices

    A new final guidance document issued by the US Food and Drug Administration (FDA) is intended to "promote" clinical studies of new medical devices under the agency's Investigational Device Exemption (IDE) regulations, but no longer includes a program proposed by FDA in 2013 meant to accelerate the clinical assessment process. Background Much like their pharmaceutical counterparts, medical device companies must first obtain approval from FDA to conduct a clinical trial o...
  • When is a Live Case Presentation Promotional? FDA Draft Guidance Clarifies

    A new draft guidance document published by the US Food and Drug Administration (FDA) is aimed at clarifying which information should be included in an investigational device exemption (IDE) application if the sponsor intends or anticipates including a "live case presentation" during the course of the clinical trial. Background Many high-risk (Class III) "significant risk" medical devices are subject to the premarket application (PMA) process, which requires sponsors to ...
  • Final FDA Guidance on IRBs Illustrates Common Problems Faced in Trial Setup Phase

    The US Food and Drug Administration (FDA) has announced the publication of a new guidance document intended to guide institutional review boards (IRBs), clinical investigators and sponsors of clinical trials on whether clinical sites are compliant with regulations and whether an investigational application must be submitted to FDA. Background Clinical research is at the heart of FDA's regulatory oversight capacity. Good review decisions rely on good clinical data-r...
  • In Response to MDUFA Commitments, FDA Prepares to Make Changes to IDE Submission System

    Medical device regulators at the US Food and Drug Administration (FDA) are planning to unveil a new technology platform in August 2013 through which industry will be expected to submit clinical trial requests, the agency announced today. The change is occurring as a result of FDA's commitments to industry under the Medical Device User Fee Act of 2012, a subset of the Food and Drug Administration Safety and Innovation Act (FDASIA) . As outlined in a commitment letter a...
  • FDA Guidance Sets Up Voluntary New IDE Submission Process Aimed at Correcting Deficiencies

    US regulators today released a new draft guidance document that looks to clarify the US Food and Drug Administration's (FDA) expectations when it comes to approving an investigational device exemption (IDE) application that permits a sponsor to conduct a clinical study involving a medical device. Background Much like their pharmaceutical counterparts, medical device companies must first obtain approval from FDA to conduct a clinical trial on an investigational product. ...
  • Program Intended to Clear Path for Easier Medical Device Studies Kept Alive

    The US Food and Drug Administration (FDA) has announced the extension of a pilot program first announced in November 2011 that aims to facilitate early feasibility studies for experimental medical devices. Background The 2011 announcement by FDA explained that the agency "intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the investigational device exemptions (IDE) requirements." IDE applications ar...