Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, is anyone ready? Well, let us have a look.
The agency action includes all non-NIOSH-approved disposable respirators, including imported KN95s.
FDA also supports the removal of the HeartWare HVAD System from the market.
The key is to keep quality high and risk low.
It’s time for medtech design engineers to take a page from the enterprise security playbook.
The goal is to establish a baseline of cybersecurity hygiene and assurance for devices that are part of the national critical infrastructure software supply chain.
Medtech companies must account for a more complex web of influencers on purchasing.
Drop the checkbox mentality and embrace accountability and understanding.
URGENT/11 introduces risks to medical device and hospital networks, and could allow a remote attacker to take control of a medical device such as an anesthesia machine of insulin pump.