Helping Companies Navigate The COVID Pandemic
The Sterling Medical Devices team has been at the forefront of the COVID-19 global health crisis in engineering new devices and assisting and expediting an Emergency Use Authorization (EUA) through the U.S. Food and Drug Administration (FDA) for medical products, under Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 USC §360bbb-3).
In just a few short months, our team has taken on several matters to help clients design and fabricate new items and attain EUAs from the FDA for critical medical devices and various types of personal protective equipment (PPE).
As the global pandemic of the coronavirus (COVID-19) continues to roil the world, healthcare professionals face shortages of medical devices and equipment. The FDA has moved to expedite market authorizations for certain products needed to address the public health emergency and has issued EUAs for medical devices and IVD test kits to diagnose and treat patients with COVID-19. Under EUA declarations, the FDA has the authority to authorize rapid emergency use of specific devices via expedited premarket review during public health crises such as the coronavirus pandemic.
The COVID-19 pandemic requires a variety of aspects for the mitigation of this evolving global health crisis. Sterling Medical Devices teams are assisting our clients in navigating the continually changing regulations and working with the relevant government agencies to develop creative approaches that respond to immediate needs, and potentially alter the long-term implications of this disease.
Below are examples of a few key areas in which our team can assist clients.
Telehealth and remote patient monitoring
We offer disease monitoring and patient-provider communication tools that have become routine as our healthcare system works to combat COVID-19. Our team has worked on solutions that allow clinicians to monitor physiological parameters using digitally connected, non-invasive devices, and medication modifications through connected care. We have assisted clients in implementing these solutions, whether it be through expedited 510(k) notices or enforcement discretion for products that do not fall under traditional EUAs.
Emergency Use Authorization
Authority has been granted to the FDA to permit the use of unapproved medical products or unapproved uses of approved medical products to diagnose, treat, or prevent SARS-CoV-2 infection and COVID-19 disease. We have helped many clients submit COVID-19 related EUA requests: ventilators, respirators, and their associated parts; remote monitoring devices; surgical masks and other PPE; and other treatment devices. We are closely tracking the FDA’s evolving guidance on EUAs and new enforcement discretion approaches during the pandemic, and helping manufacturers offering COVID-19 tests and test validation – who rely on EUA authority – to remain in compliance with FDA standards.
New product engineering
As the design and development of new devices is needed to combat this novel virus, our teams can help to engineer entire medical devices or even a single component of a larger device or system, including various mechanisms and implements that can be used to treat COVID-19 patients, or implantable, wearable, and portable medical devices meant to manage their symptoms. In keeping with the requirements set forth by the FDA as part of Design Controls (21 CFR 820.30), we compile and manage all design history files, which describe the design history of a finished device, for all new products we engineer.
Remote audits and inspections
These have become necessary as travel restrictions affect the ability of the FDA, notified bodies, and MDSAP Auditing Organization to perform on-site checks. Further, limitations on personnel and staffing are creating challenges for completing scheduled internal audits or preparing for preapproval or post-market surveillance inspections. Our team has received ISO 13485 auditor certification and has developed a plan for conducting remote Quality System Audits of most elements of your Quality Management System. We can use numerous platforms, including Web-Ex, Zoom, Skype, Google Meet, and others. We also can utilize secure file transfers to ensure confidentiality and data protection.
For more information on our COVID-19 related services, please contact our team today.