• Regulatory NewsRegulatory News

    FDA Lays Out Plans for Summary Device Malfunction Reporting

    The US Food and Drug Administration (FDA) on Friday released a proposal that would allow medical device manufacturers to submit malfunction reports for certain devices to the agency in summary format on a quarterly basis. Background In 2007, the Food and Drug Administration Amendments Act made changes to FDA's reporting requirements for device malfunctions to allow for summary reporting of malfunction for Class I and Class II devices "that are not permanently implanta...
  • 2.3% Tax on Medical Device Companies to Take Effect in 2018

    As some companies cheer new tax cuts, medical device companies will ring in the new year with the reinstatement of a 2.3% tax put in place by the  Affordable Care Act , after efforts to permanently repeal or delay the tax failed. Scott Whitaker, president and CEO of the device industry group AdvaMed, sent a letter to President Donald Trump on Wednesday, highlighting Congress’ failure “to address a punitive tax that singles out the American medical technology ind...
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    CDRH Sees Spike in Pre-Market Submissions With Patient-Reported Outcome Measures

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017. Over a six-year period, the report says CDRH observed a more than 500% increase in the number of pre-market submissions that include PRO measures. And in FY 2017, more than 75% of approved, pivotal original and new study investigational device...
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    Congress Looks to Delay Medical Device Tax by 5 Years

    The House GOP are looking to bring together an 11th-hour fix to stop a tax on medical device companies from taking force as of 1 January 2018. The 2.3% tax, which was put in place by the Affordable Care Act but then delayed through the end of 2017, would be delayed another five years under the GOP bill . Industry group AdvaMed commended the leadership of House Ways & Means Committee Chairman Kevin Brady (R-TX) and Reps. Erik Paulsen (R-MN) and Jackie Walorski (R...
  • Feature ArticlesFeature Articles

    A New Regulatory Paradigm for Medical Devices in India

    This article explains medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes. Introduction Medical devices are a multi-billion-dollar global industry with continuous growth opportunities due to advancements in technology and new innovations. However, innovations and new advancements do not always reach patients due to a lack of clarity related to the approval p...
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    FDA Warns California Device Company for Failing to Disclose Serious Injury

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last month to Sacramento, California-based Hand Biomechanics Lab after the firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices. Following an inspection last June and July, FDA said Hand Biomechanics failed to submit a report no later than 30 calendar days after it became aware of information that reasonab...
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    FDA, CMS: Second Parallel Review Decision Ever for NGS Test

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test. The test was reviewed under FDA and CMS' parallel review program, and is only the second test to be approved and cleared under the program since its inception in 2011, the first being Exact Sciences' Cologuard colorectal cance...
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    FDA Finalizes 2015 Draft Guidance on UDI Marking Requirements

    The US Food and Drug Administration (FDA) on Thursday finalized guidance first released in 2015 to clarify when direct marking of devices with a unique device identifier (UDI) is required. FDA requires a device to be directly marked with a UDI when the device is intended to be used more than once and intended to be reprocessed before each use. The guidance provides FDA's interpretation of the terms, "intended to be used more than once" and "intended to be reproces...
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    The Medical Device Coordination Group: a new Authority Under EU Device Regulations

    This article discusses the organization and functions of the Medical Device Coordination Group (MDCG) established under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The article explains how both groups will be important players in the conformity assessment body 'notification' process and in determining how notified bodies assess and certify devices and in serving as a reviewing body for making regulatory and jurisdi...
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    Asia Regulatory Roundup: China Strengthens Supervision of Online Drug, Device Sales (7 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Strengthens Supervision of Online Drug and Medical Device Sales The China Food and Drug Administration (CFDA) has moved to strengthen oversight of online sales of drugs and medical devices. CFDA outlined its plans in a notice instructing its regional outposts to step up their monitoring of the internet and make it easier for the public to alert them of illegal a...
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    Journal Editors Should Encourage Disclosures of CDRH's Role in Trial Designs: JAMA Viewpoint

    Medical and research journal editors should encourage research authors to disclose the role of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in clinical trial design and execution, Aaron Kaplan of the Heart & Vascular Center at Dartmouth-Hitchcock Medical Center and Ariel Stern of Harvard Business School, wrote in a JAMA viewpoint. Kaplan and Stern offer four main reasons for consistently disclosing FDA/CDRH involveme...
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    Needle Destruction Devices: FDA Proposes Reclassification

    The Food and Drug Administration (FDA) on Monday proposed reclassifying the needle destruction device, renamed as "sharps needle destruction device," from a Class III device into Class II (special controls), subject to premarket notification. FDA said it is proposing this reclassification on its own initiative based on new information. If finalized, this order will reduce regulatory burdens as these types of device makers will no longer be required to submit a pre...