Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Jan 91 min read

USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions

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

Sep 10, 20232 min read

USFDA Guidance: Premarket Notification [510(k)] Submissions

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

Feb 21, 20232 min read

USFDA Med. Device: Guidance on Laser Products, Diagnostics, X-ray & Ultrasonic Diathermy Devices

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

Sep 29, 20211 min read

USFDA’s Electronic Submission Template for Medical Device 510(k) Submissions

On 28-September, 2021 USFDA released draft guidance to assist sponsors in using an electronic template for submitting a premarket...

Aug 30, 20211 min read

Draft MD Guidance on Performance Criteria for Safety and Performance Based Pathway - USFDA

On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k).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