USA – FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
The US Food and Drug Administration (FDA) published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) products can submit...
USA – FDA releases draft guidance for non-spinal orthopedic bone fixation devices
The US Food and Drug Administration (FDA) has released a new draft guidance outlining what information should be included in premarket submissions for orthopedic...
USA – Guidance gives FDA authority to reject devices due to poor cybersecurity
While final guidance gives the US Food and Drug Administration (FDA) the authority to deny a new product application the product’s cybersecurity measures don’t...
USA – FDA finalizes guidance allowing some contact lens sponsors 510(k) predicate leeway
The US Food and Drug Administration has finalized a guidance that allows some manufacturers to submit 510(k) applications for soft contact lenses based on...
USA – FDA eases labeling, clarifies IVD requirements in COVID transition guidances
The US Food and Drug Administration (FDA) has made several changes to its guidances for transitioning medical devices and diagnostics from COVID-related authorization to...
USA – New rule directs mammography facilities to tell patients about breast density
The US Food and Drug Administration (FDA) has issued a final rule intended to ensure patients are better informed about their breast tissue density...
USA – We keep trying to make AI therapists. It’s not working.
We keep failing at making an artificial-intelligence Sigmund Freud, and there is both value and risk in leaning on technology to improve our mental...
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...
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...
USA – Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related...
