USA – Lasers: FDA publishes guidance on surveying, leveling and alignment products
The US Food and Drug Administration (FDA) has finalized a 2014 guidance that lays out its thinking what is and isn’t a regulated laser...
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 Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do...
Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). The...
USA – MedCon: Consider the device risk management file a ‘living document’
Device manufacturers need to keep their risk documentation up to date throughout the total product life cycle by monitoring production and post-production information, according...
USA – Patient preference information: Researchers offer insights on medical device clinical trial design
The US Food and Drug Administration (FDA) has increasingly called for the inclusion of patient preference information (PPI) to inform its regulatory decision-making for...
USA – FDA guidance proposes devices be deemed adulterated for refusing inspections
The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market...
USA – FDA finalizes guidances on device post-approval studies, postmarket surveillance
The US Food and Drug Administration (FDA) on 7 October released two final guidances to assist manufacturers of moderate- to high-risk medical devices to...
USA – Industry asks FDA to clarify voluntary malfunction reporting program requirements
Medical device industry groups are asking the US Food and Drug Administration (FDA) to provide more clarity on what products will qualify for its...
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...
USA – FDA updates guidance on identifying and responding to deficiencies
The US Food and Drug Administration has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the...
