Blog 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)...

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....

USA: FDA Revises Guidance on Post marketing Studies and Clinical Trials

October 25, 2019
Standards

The US Food and Drug Administration (FDA) revised its draft guidance provides information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21...

EU: EC Offers New Site Suitability Template under Incoming Clinical Trial Regulation

October 23, 2019
Standards

The European Commission (EC) published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which...