FDA in 2021
The FDA uses a variety of vigilance and compliance tools to ensure safety for the public. Ideally clinics and practitioners will follow the guidance of the agency and respond promptly to any warning or critique in how they practice medicine.
A company that produces medical devices must comply with each country’s safety criteria. There is an international standard that is suitable for many countries called ISO 13485. The FDA might decide this year to follow a similar regulatory pathway as QSR.
It will be a crucial year for the FDA and clinicians as many stakeholders will want to see how medications and devices are applied after authorized use for COVID-19. Emergency Use Authorizations (EUA’s) are not full, standard approvals.
Indeed, a clearance or license to promote a therapy or device is different from approval. Each company with an EUA from the FDA will need to complete further steps to continue or cease to offer their products for COVID-19. Naturally one can expect more fresh vaccines, treatments, and tools for COVID-19 as the pandemic is still ongoing.
FDA postponed its timeline for regulatory requirements of regenerative medicine from November 2020 to May 2021. This field of treatments includes cell and gene therapies.
The agency will seek more finances to enhance its vigilance and ensure public safety. A new Congress might be stricter and more focused on compliance on this field of medicine.
Our Editorial Note: We have summarized an article that first appeared in National Law Review. You may need a subscription to read the content in its entirety. Contact us if you would like to learn more about regenerative medicine and how it may help patients with Covid-19.