Category: Standards

FDA Issues Guidances on Dual 510(k) and CLIA Waiver Applications

March 5, 2020
Standards

The US Food and Drug Administration (FDA) finalized two guidance’s providing recommendation for Dual 510(k) and CLIA Waiver by Application Studies. The purpose of this guidance is to help manufacturers...

FDA Launches New Interactive 510(k) Template Program

March 4, 2020
Standards

US FDA announced the voluntary electronic Submission Template and Resource (eSTAR) Pilot Program as an alternate method available for selected industry participants in the pilot to prepare a 510(k)...

USA: FDA Drafts Guidance on Bridging Data for Combination Products

January 21, 2020
Standards

The US Food and Drug Administration (FDA) released draft guidance on bridging information on products featuring different combinations of drug-device and biologic-device combination products. The...

IMDRF Offers Final Clinical Guidelines

November 21, 2019
Standards

The International Medical Device Regulators Forum (IMDRF) released three final documents covering clinical evaluation of medical devices, in vitro diagnostics and software as medical device products;...

South Africa released Guidelines – How to Submit EOI to SAHPRA on WHO Collaborative Registration Procedure

November 20, 2019
Standards

The South African Health Products Regulatory Authority (SAPHRA) invites applicants to submit Expressions of Interest (EOIs) for evaluation of applications using the WHO pre-qualification collaborative...

USA: FDA Modifies List of Standards for Premarket Device Reviews

October 25, 2019
Standards

The US Food and Drug Administration (FDA) modified the list of standards to assist medical device manufacturers that elect to declare conformity with consensus standards to meet certain requirements....