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  • Regulatory NewsRegulatory News

    CDRH Releases 8 Warning Letters for Foreign, US Device Manufacturers

    About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday. The warning letters were sent from February through August 2017 to three manufacturers from the US, and five  in Brazil, the Netherlands, Germany, China and Bulgaria. The release of the letters follows a story in Bloo...
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    Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings. Background Other than the Medical Devices Dispute Resolution Panel (which this guidance does not address), there are 17 device panels: (1) Anesthesiology and Respiratory Therapy Devices; (2) Circulatory System Devices; (3) Clinical Chemistry and Clinical Toxicology Devices; (4) Dental Products; (5) E...
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    European Regulatory Roundup: Industry Seeks Post-Brexit System Prioritizing Ties to EMA (31 August 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Industry Asks UK Government for Post-Brexit System That Prioritizes Ties to EMA Over Flexibility The United Kingdom life sciences industry has asked the government to prioritize maintaining close ties to regulators in Europe as it shapes the post-Brexit landscape. Offered the choice between seizing potential regulatory flexibilities created by splitting from the Euro...
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    MHRA Offers Interactive Guide on New EU Device, IVD Regulations

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released an introductory guide to help medical device manufacturers understand their obligations under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR). With the three- (for MDR) and five-year (IVDR) transition periods now underway, the new regulations will apply across EU member states from 26 May 2020 and 2022, respectively. During the transiti...
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    Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018

    Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements. For instance, device companies submitting 510(k) applications, which are for devices equivalent to ones already marketed, fees wi...
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    Qualifying Medical Device Development Tools: FDA Finalizes 2013 Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance first drafted in 2013 to formalize a program that qualifies medical device development tools (MDDT) for use in device development and evaluation programs. Background The MDDT program, which FDA’s Center for Devices and Radiological Health launched as a pilot in 2014 , is a voluntary process intended to reduce regulatory burden for developers and FDA reviewers through the qualification of too...
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    Proposed and Final FDA Rules: What’s Left in 2017

    The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings. Proposed Rulemakings Among the proposals coming are rulemakings dedicated to pediatric study plan requirements , internal decision making and supervisory review at FDA’s Center for Devices and Radiological Health, the withdrawal of a regulation that a...
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    Asia Regulatory Roundup: Australia Proposes to Align Device Regulations With EU (1 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Seeks Feedback on Proposed Alignment of Australian and European Medical Device Rules The Therapeutic Goods Administration (TGA) of Australia is proposing to align parts of its medical device regulatory requirements with those in place in Europe. TGA is gathering feedback on plans to reclassify surgical mesh and place new requirements on manufacturers of implants wi...
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    FDA Updates on Digital Health Plans, Software Pre-Certification Pilot

    The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices. According to the agency's newly released Digital Health Innovation Action Plan , FDA's Center for Devices and Radiological Health (CDRH) plans to improve the landscape for digital health technologies by developing guidance on the medic...
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    FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements

    The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. Established under the 21st Century Cures Act, the list, first published in draft form in March , is part of efforts to decrease regulatory burdens and costs for the device industry. For the complete f...
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    Novo Nordisk Warns of Possible Cracks in Insulin Devices

    Novo Nordisk A/S on Wednesday warned people with diabetes that it has detected that the insulin cartridge holder used in a select number of NovoPen Echo and NovoPen 5 lots may crack or break if exposed to certain chemicals, including certain cleaning agents. Novo spokesman Ken Inchausti told Focus that this is a global recall. Certain lots of the two devices distributed in Canada were the subject of an initial warning . Other lots distributed in the US were par...
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    Senate Health Bill Would Repeal Device Tax

    Senate Republicans on Thursday released a draft version of their bill to repeal the Affordable Care Act that, like the American Health Care Act passed in the House last May, would repeal most of the taxes created by the 2010 law. The bill, referred to as the Better Care Reconciliation Act , proposes to rework the Affordable Care Act by eliminating the individual insurance mandate, phasing out Medicaid expansion beginning in 2021 and capping Medicaid spending. Whil...