Medical devices typically go through a stringent 510K evaluation process to be certified in the US. However, as a result of the ongoing pandemic, several devices have entered the marked through the EUA or emergency use authorization, that fast tracks approvals. These devices will eventually, however, have to comply to the 510K norms to remain in the market.
Watch our quality & regulatory compliance experts, Rodney & Ram, talk about the multiple factors that companies need to keep in mind when transitioning from EUA to 510K, and how LTTS can ensure that filings are done as per regulations.
