USA – Pre-submission requests for IVDs to be accepted by FDA
The FDA in January restarted accepting pre-submissions for in vitro diagnostics that would require premarket authorization or de novo clearance. Now, the agency plans...
Europe – MDR/IVDR: Commission seeks comment on revisions to standardization request
The European Commission has released a draft amendment to its Commission Implementing Decision C(2021) 2406 to update the list of harmonized standards it will...
Brazil – ANVISA extends Brazilian Good Manufacturing Practice requirements to more medical device manufacturers
ANVISA, Brazil’s medical device market regulator, has expanded quality management system certification requirements to additional types of manufacturing units for some higher-risk products.
According to...
USA – FDA asks manufacturers to develop risk management plans to avert shortages
The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to...
Brazil – Brazil’s ANVISA repeals medical device regulations related to the coronavirus pandemic
Brazilian medical device market regulator ANVISA announced the repeal of several regulations and requirements related to the COVID-19 pandemic which have been deemed no...
USA – FDA moves forward with Voluntary Improvement Program to bolster medical device quality
The US Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device...
USA – Mirvie’s Preeclampsia Test Designated an FDA Breakthrough Device
South San Francisco, Calif.-based Mirvie has secured the FDA’s Breakthrough Device designation for its test to indicate a woman’s risk of developing preeclampsia during...
USA – FDA drafts guidance on medical device voluntary improvement program
The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation in a permanent medical device Voluntary Improvement Program (VIP)...
USA – First in vitro diagnostic for early Alzheimer’s detection gets FDA blessing
The US Food and Drug Administration (FDA) has authorized the first in vitro diagnostic to help diagnose early Alzheimer’s disease. The agency said the test minimizes...
Europe – 3EC International becomes seventh Notified Body designated under EU IVDR
3EC International becomes seventh Notified Body designated under EU IVDR...
