A Regulatory Assessment of 2019 and Looking Ahead to the Regulatory Landscape in 2020 and Beyond…

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]:

• Steps toward a new, tailored review framework for artificial intelligence-based medical devices
• Warning letter to a genomics clinical laboratory for illegally marketing a genetic test as a predictive test for predicting patients’ responses to specific medications
• Approval of the first targeted therapy for metastatic bladder cancer, the first PI3K inhibitor for breast cancer, a new treatment for refractory multiple myeloma, the first therapy for rare joint tumor (symptomatic tenosynovial giant cell tumor), pexidartinib capsules (Turalio), and the first therapy to treat patients with rare blood disorders, a new type of therapy to treat advanced urothelial cancer and new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies
• Order to manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices due to safety issues
• FDA takes first and second action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma; as well as approval of a new treatment option for patients with chronic lymphocytic leukemia 
• FDA awards two grants for natural history studies in rare diseases and 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
• Medical device availability and potential shortages due to certain sterilization facility closures, followed by new steps to advance innovation in medical device sterilization with ethylene oxide

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:

• Product labeling changes to include responsibility contact information, UDI and additional product transparency
• EUDAMED did not launch as expected and received a two-year extension for compliance to May 2021
• Authorized representatives, importers and distributors of medical devices and IVDs – aimed at these regulatory roles, with key impacts of the regulations on their responsibilities
• Incorporated clinical evaluation requirements into the design and development process, with guidance requirements for clinical evaluation reports (CERs),
• Post market surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) procedural and documentation requirements
• Collaboration between regulatory and quality infrastructure controls with the incorporation of quality agreements to demonstrate supplier control,

 
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”:

• Transitional QMS gap assessments and re-certification updates from ISO 13485:2012 to ISO 13485:2016
• Medical Device Single Audit Program (MDSAP) initiatives and audits to be complete for those medical device companies who want to continue to sell their products with Canadian classifications of Class II and higher; from the original CMDCAS endorsement on existing ISO 13485:2012 QMS certificates.
• FDA intention to harmonize and modernize the Quality System regulation for medical devices. [5]
• The issuance of ISO 14971: 2019, which will align the risk-based approach for medical device quality management system identified in ISO 13485:2016; as well as on benefit-risk evaluation, which is in line with changing regulatory requirements such as the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

From such an industrious and policy productive 2019, what further alignments and changes can we expect in 2020 and beyond.

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:

• More guidance regarding UDI, for both GUDID for Class I and non-classified products due to be in full compliance by September 2020[8]; as well as more information regarding EUDAMED’s database requirements and other global markets.
• Standard updates based on MDR and IVDR general quality compliance requirements such as, but not limited to[9]:
  • ISO/DIS 15223-1-Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
  • ISO/PRF TR 20416- Medical devices — Post-market surveillance for manufacturers           
  • ISO/DIS 20417 - Medical devices — Information to be provided by the manufacturer
  • IEC 62366-1:2015/DAMD 1 - Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
• Standard updates specific to IVDR and Clinical Laboratories such as, but not limited to[10]:
  • ISO/AWI 15189 - Medical laboratories — Requirements for quality and competence
  • ISO/FDIS 15190 - Medical laboratories — Requirements for safety
  • ISO/FDIS 17511 - In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
  • ISO 18113 – Part 1 through 5 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling).
  • ISO/AWI 20658 - Medical laboratories — Requirements for collection, transport, receipt, and handling of samples
  • ISO/DIS 21151 - In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples.                     

The landscape changes for 2019 will not slow down in 2020 and beyond.  With the information that has been already been announced, we can expect further and impactful changes in 2020 and Boudicca will continue to blog on critical issues for the medical device industry.


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
​