• Regulatory NewsRegulatory News

    Concussion Assessments: FDA Warns Against Using Unapproved Devices

    The US Food and Drug Administration (FDA) on Wednesday warned against using a smartphone- or tablet-based app to assess whether an injured or possibly concussed person is suffering from a change in physical or mental status including vision, concentration, memory, balance and speech. After identifying several manufacturers marketing devices for concussion diagnosis, treatment or management without FDA’s approval or clearance, the agency said it issued a safety communica...
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    CDRH Warns of Device Supply Issues Following Suspension of Illinois Sterilization Facility

    Citing concerns of increased cancer risks, the Illinois Environmental Protection Agency (EPA) last month issued a seal order to halt any new sterilization cycles using ethylene oxide at a Sterigenics facility in Willowbrook, IL. “Recent elevated sampling results, along with Sterigenics' refusal to voluntarily suspend operations, have resulted in the issuance of the Seal Order,” the Illinois EPA said . Sterigenics, meanwhile, said in a statement: “The Illinois EPA’s ...
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    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...
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    Bipartisan Group of Lawmakers Urge Permanent Repeal of Device Tax

    A bipartisan team of eight Congressional leaders are circulating a “Dear Colleague” letter to urge fellow members of Congress to permanently repeal of the 2.3% medical device excise tax before it is reinstated next year. The device tax has only been in effect for two years—between 2013 and 2015—since it was introduced in 2010 under the Affordable Care Act . From device firms and industry groups to patient advocacy groups and health research organizations, the push agai...
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    China’s NMPA Cites Overseas Device, IVD Companies

    China’s National Medical Products Administration (NMPA) published overseas inspection results in late January, highlighting 17 overseas medical device and IVD manufacturers that were cited, including BD and Boston Scientific.   Since November 2017, when NMPA began to publish overseas inspection results, a total of 41 manufacturers have been cited, according to ChinaMed Device, LLC, which is a medical device and IVD consulting firm based in Boston, and is a certified NM...
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    AdvaMed and AAMI Weigh FDA Draft Guidance on Voluntary Consensus Standards

    Medical device industry group AdvaMed and the Association for the Advancement of Medical Instrumentation (AAMI) are seeking additional information from the US Food and Drug Administration (FDA) on draft guidance related to the recognition and withdrawal of voluntary consensus standards. The 8-page draft from September describes the procedures that FDA follows and the actions the agency may take during its review and evaluation of requests for standards recognition or ...
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    PMA Denials: Why so Few?

    In the pharmaceutical industry, complete response letters, or rejections, are a common occurrence. And though they aren’t frequently explained in detail publicly, the public is still usually notified that the company has received such a letter. But in the world of medical devices, failing to win approval for a high-risk device is a much more closely held secret, and companies can withdraw their applications rather than be denied approval.   A Federal Register notice ...
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    Medical Device Validation: What You Need to Know and Why It's Important

    Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max Sherman, the editor of RAPS’ recently published second edition of The Medical Device Validation Handbook . Unfortunately, many regulatory and quality professionals, and others involved in device compliance, lack the necessary knowledge and expertise. “People need a greater unders...
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    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...