FDA announces plan to resume on-site inspections in the US this month

By Jamie Bell

16 Jul 20

The FDA is monitoring Covid-19 cases and hospitalisations across the US to determine places which will be safe…

RegulationApprovals

Medtech industry ‘remains concerned’ about implementation of new EU IVD regulations

By Jamie Bell

14 Jul 20

Trade association MedTech Europe is 'raising the alarm' over the implementation of new EU IVD regulations, which are…

RegulationRegulatory Policy

MHRA warns manufacturers temperature screening is ‘not a reliable way’ to detect Covid-19

By Jamie Bell

08 Jul 20

Claiming temperature screening products can reliably detect Covid-19 could put people’s health at risk, according to the MHRA's…

RegulationRegulatory Policy

Sommetrics requests emergency use authorization to introduce its aerSleep product for sleep apnea patients at risk of COVID-19

By NS Medical Staff Writer

24 Jun 20

The intent is to reduce transmission of SARS-CoV-2 by those with documented or suspected infection by replacing CPAP…

RegulationRegulatory PolicyPatient Care Devices

US Department of Defense to boost Covid-19-related production with $100m initiative

By Jamie Bell

23 Jun 20

The Department of Defense has agreed to fund Covid-19-related production projects following an agreement with the US Development…

RegulationRegulatory Policy

Coronavirus (COVID-19) update: FDA issues warning letters to companies inappropriately marketing antibody tests, potentially placing public health at risk

By NS Medical Staff Writer

18 Jun 20

Agency continues effort to help protect public health from fraudulent products

Diagnostic DevicesRegulationRegulatory Policy

Lumis: Supporting effective vendor management and oversight for clinical investigations

ByNS Medical Devices Staff Writer

05 Jun 20

Small sponsor companies depend heavily on outsourcing their clinical trial activities due to limited resources, specific knowledge and/or…

RegulationApprovals

Coronavirus (COVID-19) Update: FDA publicly shares antibody test performance data from kits as part of validation study

By NS Medical Staff Writer

05 Jun 20

These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for…

RegulationRegulatory Policy

EU MDR: Delayed by Covid-19 but what will it mean for the medical device industry?

ByKim Trautman, executive VP, NSF International

03 Jun 20

The new EU MDR has been delayed until May 2021 due to the Covid-19 crisis, but it still…

RegulationRegulatory Policy

EU confirms Medical Devices Regulation is postponed until 2021

By Dan Robinson

20 Apr 20

The MDR changes will enforce stricter rules on clinical evaluation processes, safety, classification and performance of medical device…

RegulationRegulatory Policy