Medical device companies often have a globally distributed workforce which can include remote specification developers and, more likely, manufacturing sites. In China alone, where the virus was first detected, many medical device companies have manufacturing sites, utilize contract manufacturing sites, and get medical device components – all in China. The disruption in this supply chain will impact device companies and can delay getting devices to customers which can negatively impact healthcare.
Realizing the potential impact on manufacturers’ supply chains, the United States Food and Drug Administration (FDA) issued a “Coronavirus (COVID-19) Supply Chain Update” on February 27, 2020 detailing how they are monitoring the medical device industry dealing with the COVID-19 outbreak. To monitor potential impacts including shortages of drugs and medical devices the FDA has set up an email box, firstname.lastname@example.org, to enable medical device manufacturers can report shortages.
A major concern that has arisen during the COVID-19 crisis is the lack of ventilators available in the US healthcare system to aid COVID-19 patients. To help manufacturers dealing with supply chain shortages of ventilators the FDA issued the policy guidance, "Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency". The FDA hopes that this policy change will create more flexibility for manufacturers that must make device modifications to address current manufacturing limitations or supply shortages.
Per the policy, changes to the devices that would normally require a 510(k) will not need to have one submitted for the duration of the public health emergency. Manufacturers must validate the changes to their device and document the change in their device master record and change control records. The policy guidance also describes the FDA's intended approach to Emergency Use Authorizations (EUA) and provides a website and the information requested by FDA to make their determination as to whether an EUA can be issued.
Manufacturers who are not currently engaged in medical device manufacturing may also submit for an EUA. FDA intends to work collaboratively with these manufacturers to get through the EUA process. For example, Ford Motor Company announced recently that it is joining forces with medical device manufacturers including 3M and GE Healthcare to quickly expand production of urgently needed medical equipment and supplies for healthcare workers, first responders, and patients fighting COVID-19.
Device manufacturers are also making a positive impact during the crisis by developing diagnostic tests for COVID-19. Multiple In Vitro Diagnostic (IVD) manufacturers are working to develop COVID-19 tests and there are currently multiple test kits on sale that have been made available under CLIA waivers and EUAs with additional testing kits under development. The FDA has relaxed its requirements for CLIA-certified labs and is allowing them to use their test kits without needing to have Emergency Use Authorization. However, the CLIA labs do need to submit an Emergency Use Authorization application within 15 days of validating their new test. BioFire, a division of bioMerieux, has received an EUA from the FDA for a COVID-19 test kit, and Mesa Biotech has received an EUA for their Accula device which is designed to allow for near-patient testing with the results in about 30 minutes.
Interested in learning more about this topic? Join us on Friday, April 17 for our first ever RQM+ Live! A new weekly and interactive live show featuring expert panelists discussing hot topics, challenges, and solutions in the medical device industry. This episode will focus on moving medical device manufacturing out of China. Click the button below to learn more and register for free!
As always, if there are questions on the guidelines ask your Notified Body (NB). R&Q experts are here to help you navigate the difficult road ahead with ample virtual content and remote experts on hand so don't hesitate to reach out to your R&Q representative and contact us today.
 Cairns, Elizabeth. Evaluate Vantage. Few groups have developed Covid-19 diagnostics – but this will change. 10 March 2020. Accessed 13 March 2020. https://www.evaluate.com/vantage/articles/news/policy-and-regulation/few-groups-have-developed-covid-19-diagnostics-will
 Hale, Conor. Fierce Biotech. FDA authorizes hand-held COVID-19 diagnostic test. 24 March 2020. Accessed 24 March 2020. https://www.fiercebiotech.com/medtech/fda-authorizes-hand-held-covid-19-diagnostic-test
 FDA: Office of Medical Products and Tobacco, Center for Devices and Radiological Health. Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff. March 2020. Accessed 13 April 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus
 Hahn, Stephen M. M.D., Commissioner of Food and Drugs - Food and Drug Administration. FDA Statement: Coronavirus (COVID-19) Supply Chain Update. 27 February 2020. Accessed 14 April 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chain-update
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