• Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live (16 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Provides Guidance as Black Triangle Adverse Event Scheme Goes Live Australia’s Therapeutic Goods Administration (TGA) has posted guidance on its black triangle adverse event reporting scheme. The scheme came into force at the start of the year, leading TGA to share a guide that addresses some of the uncertainties expressed by industry in advance of the go-live day...
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    Markey and Warren Re-Intro Bill to Repeal Medical Device Tax

    Sens. Ed Markey (D-MA) and Elizabeth Warren (D-MA) re-introduced a bill from 2015 last week that would permanently repeal a 2.3% medical device tax that was delayed for two years but took effect at the beginning of this year. The re-introduction of the bill, originally included in the Affordable Care Act (aka Obamacare), highlights how many device companies are in Massachusetts. And similar to the 2015 legislation, the Massachusetts Democrats are looking to pay fo...
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    FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices

    The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years. A Federal Register notice on guidance released Friday, which FDA said takes effect immediately, said: "FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Ag...
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    Asia Regulatory Roundup: China Posts Guiding Principles on Device Trials (9 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Seeks Feedback on Drug Data Management Practices China is seeking feedback on its draft drug data management practices. The China Food and Drug Administration (CFDA) text details how individuals and organizations involved in the development, production, distribution and monitoring of drugs should ensure the accuracy and traceability of the data they generate. C...
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    Asia Regulatory Roundup: TGA Adopts Guidance on Device Priority Review Pathway (2 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Adopts Guidance on Medical Device Priority Review Pathway Australia’s Therapeutic Goods Administration (TGA) has adopted guidance on its priority review pathway for medical devices. The adoption of the guidance allows developers of highly promising devices aimed at serious unmet needs to jump to the front of the queue when they file for approval. Devices must mee...
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    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...