A Regulatory Assessment of 2019 and Looking Ahead to the Regulatory Landscape in 2020 and Beyond…1/6/2020 In order to understand what changes we can expect for medical devices in 2020, we should review the pivotal changes that took place in 2019. Starting with FDA announcing in early January 2019 that the 510(k) Program would be strengthened by re-evaluating the requirements for “traditional”, “abbreviated” and “special 510(k)” pre-market applications. [1]
In February 2019, the creation of the Tri-Agency Task Force (FDA, CDC and CMS) for Emergency Diagnostics task force, “to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies.”[2] March 2019 saw another convergence within the FDA and its respective centers to modernize clinical trials to advance precision medicine, patient protections and more efficient product development. This announcement came with the Clinical Trial Transformation Initiative and the release of the following guidance documents: “Enrichment Strategies for Clinical Trials to Support Determinations of Effectiveness of Human Drugs and Biological Products, and A Risk Based Approach to Monitoring of Clinical Investigations: Questions and Answers Guidance for Industry,” and “Severely Debilitating or Life Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals (SDLTHDs).” [3] In late March 2019, the biotech community was shocked by the news that the Chief Commissioner of the FDA, Dr. Scott Gottlieb, stepped down from his post after his two year tenure (May 11, 2017 to April 5, 2019). This announcement was a shock to industry because of the early-adaption platform initiatives including: e-cigarettes and vaping with minors, price competition for drugs and inadequate generic competition, opioid abuse and speeding up of drug and medical device approvals. Other major US announcements included[4]:
Internationally, we saw global challenges and alignment issues with the incorporation of the European regulatory framework to Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746 with the changes to:
We will continue to see an increase in manufacturers’ annual budgets while they maneuver through incorporating the new and additional European pre-market technical file/design dossier applications requirements and legacy product maintenance initiatives. The medical device industry in 2019 saw a major shift from a compartmentalized approach to regulatory and quality infrastructure to a transitional harmonized approach towards compliance control with the implementation of a three-year grace period expiration (March 2019) of ISO 13485:2016, the standard for Medical Device Quality Management System. This was clear with the “push”:
From the US, we can expect guidance documents and new legislation that looks at harmonizing globally with continued international initiatives such as, but not limited to MDR/IVDR, UDI labeling, Brexit and the pharmaceutical/biopharmaceutical and medical device shortage impact; as well as takes a full-year’s view of the 2019 inducted Commissioner for FDA, Dr. Stephen M. Hahn and whether his passion for medical oncology and radiation oncology will drive the 2020 initiatives. Cybersecurity and big data had an early push in 2019; but fell silent for the remainder of the year. With the issuance of ISO 14971:2019, industry is anxious to see what type of impact this will have on the standard IEC/EN 62304 Medical Device - Software Life Cycle Processes; and whether we can expect this standard to be revised; or with the release of ISO 24971, which is still under development (a revision to ISO 24971:2013)[6], contain the additional information to support software risk? In April 2020, FDA expects to publish a notice of proposed rule making (NPRM) on the modernization of the quality system regulation for medical devices. To help with the transition, the Association for the Advancement of Medical Instrumentation released a technical information report to help the industry prepare for the revision of 21 CFR 820, which will harmonize with ISO 13485:2016[7] We also expect to see in 2020:
Boudicca Dx, LLC has the expertise to support and assist medical device companies with maneuvering through the current and updated guidances, rule-making, and legislation changes that can impact your quality management, laboratory, clinical and regulatory infrastructure. Reach out to kelly@boudiccadx.com for further details about Boudicca Dx LLC’s, our capabilities. [1]January 22, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and-4 [2]FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies. https://www.fda.gov/news-events/press-announcements/fda-cdc-and-cms-launch-task-force-help-facilitate-rapid-availability-diagnostic-tests-during-public [3]Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product developmenthttps://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-strategies-modernize-clinical-trials-advance [4]Press Announcements. https://www.fda.gov/news-events/fda-newsroom/press-announcements?page=19 [5]https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0910-AH99 [6]STANDARDS BY ISO/TC 210 - Quality management and corresponding general aspects for medical devices. Current work program. https://www.iso.org/standard/74437.html [7]https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0910-AH99 [8]Compliance Dates for UDI Requirements. https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/compliance-dates-udi-requirements [9]STANDARDS BY ISO/TC 210 - Quality management and corresponding general aspects for medical devices. Current work program. https://www.iso.org/standard/74437.html [10]STANDARDS BY ISO/TC 212 -Clinical laboratory testing and in vitro diagnostic test systems- https://www.iso.org/committee/54916/x/catalogue/p/0/u/1/w/0/d/0
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