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    EMA Highlights Central Nervous System Drug Development Challenges

    The European Medicines Agency (EMA) on Tuesday published an analysis highlighting the complexity of developing treatments for central nervous system (CNS) disorders, such as Alzheimer's disease, epilepsy and schizophrenia. "Research into medicines for CNS is complex, with a higher rate of failure during the clinical development of these products compared to other fields of medicine," EMA says. To conduct its analysis, EMA says its staff members reviewed a total of 103 a...
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    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    • 22 November 2016
    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
  • Feature ArticlesFeature Articles

    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
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    FDA Warns 14 International Medical Device Companies

    The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines. By far the most common issues cited by FDA were: Number of Citations Issue 11 Failure to establish and maintain adequate procedures for imple...
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    FDA Warns Zimmer Over Quality System Issues at Montreal Plant

    The US Food and Drug Administration (FDA) has issued medical device maker Zimmer Biomet a warning letter over nine quality system issues uncovered at its facility in Montreal. The warning comes as a result of a four-day inspection of the facility that resulted in an FDA Form 483 last January, during which, FDA says its investigators found issues with the company's procedures for implementing corrective and preventative actions, medical device reporting (MDR), purchasing ...
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    Report Outlines New FDA Device Evaluation System, Coordinating Center

    A national medical device evaluation system planning board, created in part by the US Food and Drug Administration (FDA), released a new report on Monday outlining how it plans to develop such a system and a center to coordinate such efforts. Both the national medical device evaluation system (NMDES) and the coordinating center are part of a larger goal of FDA’s to expedite the generation and dissemination of reliable medical device data, including real-world evidence, i...
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    FDA Reaffirms Endoscope Washer Recall After Company Tries to Correct Devices

    The US Food and Drug Administration (FDA) has reiterated its recall of Custom Ultrasonics' automated endoscope reprocessors (AERs) after the company had proposed to correct, rather than recall the AERs, which FDA rejected as the devices fail to adequately wash and disinfect endoscopes. Duodenoscopes Duodenoscopes are a type of endoscope manufactured and sold in the US by Fujifilm, Pentax and Olympus and are notoriously difficult to clean. Customs Ultrasonics AERs, whic...
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    CDRH Bans Imports From Australian Company for Failing to Meet Quality System Requirements

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) added Australia’s TFS Manufacturing to a list of medical device manufacturers that have not met device quality system requirements. TFS says it manufactures a tissue fixation system that “repairs organ prolapse by tensioning the ligaments and bringing laterally displaced connective tissue structures, such as ligaments and fascia, together. It combines soft tissue anchors with ...
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    Device Industry Calls for Clarifications to Draft Animal Studies Guidance

    The Advanced Medical Technology Association (AdvaMed) is calling on the US Food and Drug Administration (FDA) to clarify aspects of a recent draft guidance intended to set expectations for animal studies for medical devices. Draft Guidance FDA released the draft guidance, General Considerations for Animal Studies , for public comment in October 2015. The guidance is intended to assist industry in designing, conducting and reporting data from animal studies used to de...
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    CDRH Increases Foreign Quality System Inspections

    Although the number of quality system surveillance inspections only rose slightly between 2013 and 2014 overall, the number of such inspections for foreign manufacturers increased by nearly 30%, according to new data released by the FDA’s Center for Devices and Radiological Health (CDRH). CDRH said the new numbers show that the agency, which previously upped its inspections of foreign generic drug manufacturers , has been working to increase inspections in foreign count...
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    Medical Device Audit Program Needs More Industry Involvement, Report Says

    A mid-pilot report on the international Medical Device Single Audit Program shows some progress, though work still needs to be done, particularly in terms of attracting industry participants before the expected operational launch in 2017, a recent report says. Background Back in January 2014, the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force, launched a two-year pilot program ...
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    India Unveils New Online Submission System for Clinical Trials

    India's Central Drugs Standards Control Organization (CDSCO) has launched a new online submission system for clinical trials as part of efforts to increase transparency, accountability and efficiency in processing trial applications. CDSCO says the new online system will help in the collection and organization of information on sponsors, contract research organizations, investigators, ethics committees and trial subjects. The release of the submission system comes as...