USA – US FDA announces medical device testing laboratories accredited under ASCA program

The US Food and Drug Administration has designated more than 50 laboratory sites to participate in the agency’s Accreditation Scheme for Conformity Assessment (ASCA)...

USA – Federal officials design new mask guidelines to better protect more workers

Federal officials announced new measures to help get fresh, new N95 masks to health care workers and expand their use in other industries after...
Examining US FDA criteria for medical device cybersecurity and risk management

USA – FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help...

“Artificial intelligence has the potential to transform health care to better assist health care providers and improve patient care. When AI is combined with...

USA – How to reduce bias, improve fairness in medical devices

Lessons learned in the artificial intelligence community about addressing bias could also be applied to medical devices, according to a recent perspective in the...
FDA updates safety recommendations on biotin interference in lab tests

USA – US FDA Emergency Use Authorization (EUA) routes for medical devices: Updated overview

The US Food and Drug Administration (FDA) has 26 active guidance documents related to special recommendations for medical devices during the COVID-19-associated public health...

USA – US FDA outlines next steps following COVID-19 Pandemic Recovery and Preparedness Plan...

The US Food and Drug Administration (FDA) plans to pursue five areas for near-term focus and implementation in terms of improving the agency’s responsiveness...
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

USA – HHS’ proposed 510(k) exemption proves the need for regulatory science

Authors of a recent commentary in Nature Medicine have come out against a federal notice that would exempt more than 91 medical devices from premarket notification...
ANVISA: Nearly half of all Brazil GMP certificates now issued under Medical Device Single Audit Program

Brazil – Brazilian regulators update economic monitoring requirements for some medical devices

Brazilian medical device regulator ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – US FDA to stop authorizing new imported respirators under reissued Emergency Use...

On March 24, 2021, the US Food and Drug Administration (FDA) reissued one of its Emergency Use Authorizations (EUAs) covering imported respirators that have...
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

USA – HHS proposes updates to patient labeling, BA/BE study regulation

The US Department of Health and Human Services (HHS) has released its semiannual inventory of proposed rulemaking actions, with a relatively brief to-do list...

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