• Regulatory NewsRegulatory News

    FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK

    Device firms in Sweden, Canada, Spain and the UK separately drew four US Food and Drug Administration (FDA) warning letters over good manufacturing practice (GMP) violations.   The GMP violations cited in the warning letters posted Tuesday stem from inspectional observations first noted in FDA Form 483s issued to each of the four device manufacturing facilities, following the site visits investigators conducted during 2017 and 2018.   Most of the firms issued res...
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    First Version of NEST to Launch in 2019

    The National Evaluation System for health Technology (NEST) will become increasingly crucial for tracking medical devices at FDA’s Center for Devices and Radiological Health (CDRH), though its creation continues to be fraught with limitations. The timeline for an initial version of the NEST Coordinating Center (NESTcc) is tight, Rachel Fleurence, NESTcc executive director, noted Wednesday at the MDEpiNet annual meeting at FDA’s White Oak campus. The idea for NEST origina...
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    CDRH Looks Ahead to Priorities for 2018 to 2022

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced Wednesday that it has met its three strategic goals from 2016 and 2017 and it has outlined three more for 2018 to 2022. Looking ahead to these next three years, CDRH Director Jeff Shuren pointed to three priorities: Better engage the center’s employees and decrease turnover rates, streamline and modernize at least 80% of the center’s processes, and establish new ...
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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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    CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation

    This article explains the revised classification rules, conformity assessment procedures and new requirements for clinical evidence to support the safety and performance of an In Vitro Diagnostic (IVD) medical device. Of significance, the In Vitro Diagnostic Device Regulations (EU 2017/746) transition from the prior two class system under the IVD Directive (98/19/EC) to a four-class, risk-based classification system. 1 The regulations, intended to affect greater IVD saf...
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    FDA Delays UDI Requirements for Low-Risk Devices

    The US Food and Drug Administration (FDA) on Friday notified medical device labelers that it is extending the compliance dates for certain unique device identifier (UDI) requirements for Class I and unclassified devices. Rollout of FDA's UDI rule has been fraught with challenges. Since issuing the final UDI rule in 2013, FDA has pushed back compliance dates for a number of devices in response to concerns from companies over meeting deadlines or to address specific t...
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    FDA Grants Third Extension of UDI Compliance Date to Soft Contact Lens Labelers

    The US Food and Drug Administration (FDA) last week granted a third extension for soft contact lens labelers yet to comply with the requirements of the Unique Device Identification (UDI) system because of the agency’s resource limitations. Background In September 2013, FDA published a final rule creating a UDI system and outlining labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the US, unless a...
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    Committee Recommends Adding UDIs to Insurance Claims Forms

    The group tasked with developing the standards for insurance claims forms on Wednesday recommended including unique device identifiers (UDI) on claims forms. Specifically, the Accredited Standards Committee X12 recommended that the device identifier portion of a UDI be included when high-risk devices are implanted or removed "due to safety concerns about premature failure." The recommendations are now undergoing a three-month consultation ending on 2 May 2017. Following...
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    What to do if a Device Manufacturer’s Notified Body Halts Operations? France’s ANSM Explains

    For several months now, notified bodies in the EU have ceased operations, either voluntarily or following a de-notification decision from their member state’s competent authority. As the uptick in notified body closures increases, France’s National Agency for the Safety of Medicines and Health Products (ANSM) on Monday reiterated that medical devices may only receive marketing authorization with a valid certificate and under regular device surveillance by a notified bod...
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    HHS Inspector General Calls on CMS to Incorporate UDIs Into Claims Forms

    In a letter to the Centers for Medicare & Medicaid Services (CMS) Acting Administrator Andy Slavitt on Friday, Department of Health and Human Services (HHS) Inspector General Daniel Levinson calls on CMS to work with the Accredited Standards Committee (ASC) X12 to incorporate unique device identifiers (UDIs) for implantable devices into insurance claims forms. According to Levinson, doing so could help CMS keep track of the costs associated with recalled and defective me...
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    FDA Extends UDI Compliance for Certain Class II Devices

    The US Food and Drug Administration (FDA) is giving medical device labelers two more years to comply with unique device identifier (UDI) requirements for certain Class II devices. In a letter to device labelers dated Tuesday, FDA said it is extending the UDI compliance dates for so-called device convenience kits and repackaged single-use devices and is clarifying the compliance date for device constituents for certain combination products. Under the UDI rule, FDA establ...
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    Grassley and Warren Call for UDIs to be Added to Health Insurance Claims Forms

    Incorporating unique device identifiers (UDIs) into health insurance claims forms could help improve the postmarket tracking of medical device safety concerns and performance, Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) wrote in a letter earlier this week to the chair of an Accredited Standards Committee. The Virginia-based committee is tasked with recommending changes to electronic claims forms, with the latest version of standards slated for release 1 Dece...