FDA issued proposed orders to remove the 510(k) exemption and establish special controls for most blood lancets, and require PMAs for one super-risky category of the finger-prick devices. The goal is to reduce infectious disease transmission.
FDA took the next step to raise the regulatory standards for blood lancets in response to concerns about spreading infectious disease.
The devices used to prick a patient's finger for a blood sample have been reaching the market for years as class I products with no need for a 510(k)
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.
The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.
