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The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to...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The US Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device...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The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation in a permanent medical device Voluntary Improvement Program (VIP)...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...
USA – FDA warns that some prenatal screening tests can generate false results
Some non-invasive prenatal tests (NIPT) to screen for genetic abnormalities in the fetus may generate false results, and should not be used for diagnostic...
USA – FDA offers guidance on waiver requests for pH adjusters
The US Food and Drug Administration (FDA) has issued a draft guidance on its criteria for permitting the use of pH adjusters in parenteral, ophthalmic or...
USA – FDA recommends sponsors plan to include race, ethnicity in clinical trial design
The US Food and Drug Administration (FDA) is recommending sponsors include a plan to increase diversity when proposing clinical trial designs for investigational products...
