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    FDA Amends Definition of Custom Device

    The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). Under the revised provision, as under the original custom device exemption, a device that meets the qualification of a custom device is exemp...
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    CDSCO Advances Draft Medical Device Rules, Outlines Fees

    India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders. In June, India announced it was abandoning its plan to amend the Drugs and Cosmetics Act of 1940 in favor of developing new, separate legislation for the regulation of drugs and medical devices. Shortly afterwards, CDSCO released preliminary draft rules est...
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    CDRH Outlines Top 10 Science Priorities for 2017

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) plans to leverage real-world evidence and more “Big Data” for regulatory decisions, according to a list of its science priorities for 2017. As far as what will change between 2016 and 2017, the 13-page report says that thanks to more “needs submissions from staff,” CDRH was able to identify new topic areas, including clinical trial design and precision medicine, as well as desc...
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    Common Pitfalls Associated with Modifications to 510(k)-Cleared and 510(k)-Exempt Devices

    This article identifies some common pitfalls companies often encounter when assessing modifications to 510(k)-cleared and 510(k)-exempt medical devices and offers approaches for performing these assessments to better ensure compliance with FDA expectations. Determining the regulatory impact of a modification to the design, labeling or manufacturing of a 510(k)-cleared or 510(k)-exempt medical device can be a challenging task for any regulatory affairs professional. The...
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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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    FDA Pushes Back Enforcement of UDI Rule Provisions

    The US Food and Drug Administration (FDA) on Monday finalized guidance that makes clear the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time. The shift in enforcement comes as FDA says it wants to make sure it gives companies enough time to make changes to the medical device reimbursement, supply chain and procurement systems and proces...
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    FDA Finalizes Two Medical Device Guidelines

    The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents: one on factors to consider when making benefit-risk determinations for premarket approval (PMA) and de novo classifications, and one on the concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI) that may inform FDA's benefit-risk determinations. The 62-page guidance on benefit-risk determinations, finalized more th...
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    Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program

    The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017. Under the new draft agreement, which is part of the fourth reauthorization of  the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the add...
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    European Commission Offers Guidance on Standalone Software as a Medical Device or IVD

    The European Commission is offering guidance for device companies and other stakeholders trying to determine if their standalone software should be considered a medical device, in vitro diagnostic (IVD) or neither. As the commission notes, standalone software can directly control an apparatus (e.g. radiotherapy treatment), provide immediate decision-triggering information (e.g. blood glucose meters) or provide support for healthcare professionals (e.g. ECG interpretatio...
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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 Corrects Statutory Error on Informal Hearings Linked to Banned Devices

    The US Food and Drug Administration (FDA) announced it is amending its regulations to correctly reference the statutory and regulatory provisions that provide an opportunity for an informal hearing in connection with a banned device. The correction of the error, which is taking effect immediately, will further align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and avoid any potential confusion the erroneous lists may cause, FDA says. FDA...
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    FDA Issues Draft Guidance on 510(k) Device Modifications

    The US Food and Drug Administration (FDA) on Friday released two draft guidances for public comment clarifying its policy for when manufacturers should submit a 510(k) for changes made to a medical device or its software. According to FDA, the new guidances preserve "the basic format and content of the original, with updates to add clarity," which the agency says will help align industry and agency interpretations of when a device modification warrants further FDA review...