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    FDA Proposes New Framework on Prescription Drug-Related Software

    The US Food and Drug Administration (FDA) issued a request for comment on Monday that sets forth a proposal for a new framework on the regulation of software applications for use with one or more prescription drug products.   The agency’s newly adopted digital health approaches “are still in their early stages,” FDA Commissioner Scott Gottlieb said Monday in remarks at the Reagan Udall Foundation annual public meeting. “A lot of these technologies haven’t advanced as...
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    FDA Flags Spate of GMP Violations at US Vascular

    US Food and Drug Administration (FDA) investigators revealed 11 violations of good manufacturing practices (GMP) during a March site inspection at US Vascular’s medical device manufacturing facility in Beaverton, OR, according to an FDA warning letter. Out of 12 inspectional citations first noted in an FDA Form 483, the agency investigators flagged 11 repeat observations from the firm’s previous site inspection in April 2017. “Eight of the citations you received in the ...
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    FDA Warns California Firm Over Unapproved Stem Cell Product, GMP Violations

    StemGenex Biologic Laboratories drew a US Food and Drug Administration (FDA) warning letter over illegally marketing an unapproved stem cell product and serious good manufacturing practices (GMP) violations. The violations include “some that could lead to microbial contamination,” which could in turn put patients’ health at risk, according to FDA. Agency investigators revealed 11 different violations at the firm’s facility in San Diego, following an FDA inspection condu...
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    FDA Drafts Guidance on Using Metastasis-Free Survival Endpoints in Prostate Cancer

    The US Food and Drug Administration (FDA) issued draft guidance on Tuesday to aid sponsors in using metastasis-free survival (MFS) as a clinical trial endpoint for developing drugs or biologic products indicated for treatment of nonmetastatic castration-resistant prostate cancer. Sponsors are encouraged to design clinical trials that use MFS as an endpoint based on the general design and imaging considerations as well as considerations related to the interpretation of t...
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    IMDRF Finalizes Work on Standards for Regulatory Use, Essential Principles, Personalized Devices

    The International Medical Device Regulators Forum (IMDRF) has finalized three technical documents on optimizing standards for regulatory use, the essential principles of safety and performance for medical devices and in vitro diagnostic devices, and definitions for personalized medical devices. The work to internationally harmonize medical device regulations through the final technical documents was carried out by the IMDRF standards working group, good regulatory rev...
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    Lawmaker Seeks Answers to OIG’s Findings on FDA’s Cybersecurity Policies

    A recent report from the Office of the Inspector General (OIG) “highlighted some very important issues” where the US Food and Drug Administration (FDA) “has room for improvement,” Sen. Chuck Grassley (R-IA) argued in a letter to FDA Commissioner Scott Gottlieb.   The 9 November letter from Grassley, chairman of the Senate Judiciary Committee, follows on the heels of the findings and recommendations OIG at the US Department of Health and Human Services outlined in a...
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    Health Canada Drafts Policies on 3D-Printed Implantable Devices

    Health Canada released draft guidance Thursday to aid manufacturers in preparing license applications for implantable medical devices produced by additive manufacturing or 3D-printing.   The guidance “represents the first phase of 3D-printing policy in Canada” because Health Canada intends to continuously adapt its policies to emerging issues on the topic “due to the fast-changing technological environment,” the regulator said.   3D-printed medical devices may be s...
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    CDRH Clarifies What Success Means for Special 510(k) Pilot

    Officials at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) clarified on Thursday how the center intends to assess the success of its new special 510(k) program pilot based on the types of information to be collected.   Last month, CDRH issued draft guidance to propose certain modifications to the existing special 510(k) program aimed at expanding device eligibility criteria and subsequently launched a new pilot to ope...
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    UL Wades into Cybersecurity of Connected Medical Devices

    Safety science firm UL is honing in on the cybersecurity of connected medical devices, suggesting a two-pronged approach that spans across the total product life cycles of devices and the healthcare ecosystem.   UL began wading into healthcare as it increasingly became a prime target for cyber attacks in recent years, Anura Fernando, UL chief innovation architect of medical systems interoperability and security, told Focus . Factors that drove its decision to join the...
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    Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

    Medtronic and Monteris Medical are suggesting procedural techniques to reduce unintended thermal damage linked to their magnetic resonance-guided laser interstitial thermal therapy devices, the US Food and Drug Administration (FDA) said Thursday.   The agency summarized the new information from both medical device manufacturers and provided updated recommendations in two letters to health care providers. Medtronic issued three advisory letters between June and August t...
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    Wyss Institute to Investigate Sex Disparities With FDA-funded Chip Technology Study

    Under a newly expanded research contract with the US Food and Drug Administration (FDA), Harvard University’s Wyss Institute will use its organ-on-chip technology to investigate how bone marrow responds to radiation and certain drugs differ between men and women.   Wyss’ FDA-funded investigative studies involving chip technology date back to 2013 when the agency first awarded the institute a contract valued at more than $5 million to develop a bone marrow chip, a gut...
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    EC Adds Six New Products to Borderline and Classification Manual

    The European Commission (EC) added six new medical and nonmedical products to its manual on borderline and classification cases based on the regulatory framework for medical devices.   EC’s manual is intended to serve as a tool to help manufacturers achieve time and cost savings by providing regularly updated clarifications. These policy updates clarify whether a product would be considered a medical device consistent with the European Medical Device Vigilance System (...