Regulatory Blog

The USFDA Center for Devices and Radiological Health  has recently issued three key final guidance documents focusing on orthopedic...

The 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review are pivotal initiatives by the USFDA to...

Yesterday (08 January, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research...

The Center for Devices and Radiological Health released multiple guidances earlier today (21-February-2023), related to "Laser Products,...

On 28-September, 2021 USFDA released draft guidance to assist sponsors in using an electronic template for submitting a premarket...

On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k). i.e.,...