USA – US FDA presents premarket submissions pilot program and patient-centered data resource pages

The US FDA’s Center for Devices and Radiological Health (CDRH) has introduced a new pilot program for a different method of electronic premarket submissions...
CDRH Proposed Guidances for Fiscal Year 2020

USA – CDRH FY 2021 guidance slate includes post-EUA transition plan

Surgical staplers and laparoscopic power morcellators are among devices that made the grade for the US Food and Drug Administration’s (FDA’s) slate of final...

USA – FDA releases guidance documents on biocompatibility submissions and nitinol-containing devices

The US Food and Drug Administration (FDA) has issued two new guidance documents related to premarket submissions on device biocompatibility with intact skin, as...

USA – FDA finalizes biotin interfering testing guidance

A guidance document from the US Food and Drug Administration (FDA) that addresses biotin interference testing for in vitro diagnostic devices (IVDs) has been finalized. The...

USA – During pandemic, FDA permits some respiratory swab, media swaps

Amid the coronavirus pandemic, the US Food and Drug Administration (FDA) has made new guidance immediately effective that addresses its enforcement policy for modifications...
ANVISA will implement new rules for medical device modifications in Brazil

Brazil – ANVISA publishes list of exempted healthcare products and cybersecurity guide

Brazil’s National Health Surveillance Agency (ANVISA) has issued an up-to-date list of healthcare products exempt from regulation and a new cybersecurity guide for medical...

Canada – Guidance : Public release of clinical information for drugs and medical devices...

This guidance is to provide Canadians with access to information on the safety and efficacy/effectiveness of products being used for the COVID-19 pandemic. These...
Coronavirus delays many FDA foreign inspections

USA – US FDA ASCA Program: How the new Accreditation Scheme for Conformity Assessment...

The US Food and Drug Administration recently issued final guidance for its highly anticipated Accreditation Scheme for Conformity Assessment (ASCA) pilot, effectively launching the program and...

USA – US FDA publishes trio of final guidances for Accreditation Scheme for Conformity...

As the US Food and Drug Administration formally launches the pilot for its Accreditation Scheme for Conformity Assessment (ASCA) program to streamline testing requirements...
ANVISA will implement new rules for medical device modifications in Brazil

Brazil – ANVISA suspends expedited registrations for COVID-19 products

During a recent meeting of the Collegiate Board of Directors of Brazil’s National Health Surveillance Agency (ANVISA), Emergo by UL representatives learned that ANVISA...

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