Freelance Scientist at Kolabtree
The COVID-19 pandemic has brought the world to a standstill and hit most countries very hard. The USA is in the eye of the storm and the virus has caused immense loss of life and health and has put enormous strain on the healthcare professionals (HCPs) and the hospitals.
There has been a shortage of ventilators, Personal Protective Equipment (PPEs), and test kits. All of these are medical devices. Thus, the medical device industry finds itself in the center of the gargantuan efforts needed to get us through this pandemic. The U.S. Food and Drug Administration (FDA) is the central regulatory body in the US that regulates the medical devices and combination products used for diagnosis and treatment of COVID-19- invitro-diagnostic (IVD) kits, PPEs, ventilators, surgical masks, etc. The FDA has come up with certain regulatory changes that now can ensure quick approval of these important, yet short-in-supply medical devices, reducing the time to market and thus, providing HCPs and also, other professionals with the required tools to fight this pandemic.
Emergency Use Authorization (EUA)
The FDA has issued Emergency Use Authorizations (EUAs) for various diagnostic, protective, and therapeutic medical devices to respond to COVID-19. EUAs were previously also issued during the Zika virus and Ebola virus outbreaks.
At the beginning of February 2020, FDA issued EUA for IVDs for detection/diagnosis of novel coronavirus (2019-nCoV) so that enough tests are available through the USA where the number of cases suddenly exploded.
The ventilator related EUA allows for automotive and other industrial manufacturers to start manufacturing ventilators provided that they are aware of the quality, safety, and performance standards specified by FDA. The templates for the application and further information are available on the FDA website.
However, EUA for these devices and equipment allow their use only during this pandemic and as soon as the pandemic is over, these products would need to meet the usual regulatory guidelines of FDA.
Suspension of on-site audits
FDA has decided to suspend its on-site domestic and international audits except for certain mission-critical inspections. These inspections will be identified on a case-by-case basis and will be conducted with appropriate safety measures. FDA has implemented some alternative approaches to the on-site audits. It is currently working with CDC on when and how to return to on-site audits.
FDA has issued various guidance documents that describe the agency’s interpretation of a policy or regulatory issue with regards to COVID-19. The guidance documents are addressed to the manufacturers, laboratories or the FDA staff.
Frequently Asked Questions (FAQs)
FDA has a comprehensive list of FAQs that it regularly updates with regards to COVID-19 and medical devices.
Virtual Town Halls
Since the beginning of March, FDA has been regularly hosting Virtual Town Halls for the clinical laboratories and commercial manufacturers that have developed/developing molecular tests for diagnosis of SARS-CoV-2. The main idea behind this town hall meeting is to discuss various technical challenges with respect to the development and validation of the various diagnostic tests that are being developed.
Though FDA was initially criticized for its slow response to the COVID-19 pandemic since then FDA had come up with various policy innovations and regulatory updates to ensure that the people of USA get timely access to new technology during these times where the quality, safety and performance of the devices, PPEs and diagnostic tests remain high. The FDA website has lots of resources that are pretty helpful for the manufacturers, laboratories, researchers, and HCPs to keep abreast of the latest information with regards to COVID-19.