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Pre-Market Testing Guidance Pilot Program Released by FDA

Pre-Market Testing Guidance Pilot Program Released by FDA

The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
FDA Grants EUA for Point-of-Care COVID-19 Antibody Test

FDA Grants EUA for Point-of-Care COVID-19 Antibody Test

Amidst the COVID-19 public health crisis, many companies have worked tirelessly to perfect testing technology. Assure Tech, a Chinese company based in Hangzhao, has prevailed with an antibody test with emergency use authorization. This is the first time that the FDA...