Brazil – Brazil to recognize other agencies’ decisions on devices
In a step toward consolidating regulatory reliance, The Brazil Health Regulatory Agency (ANVISA) said on 8 April that it would recognize decisions by regulators...
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 – FDA drafts guidance on essential outputs for drug delivery devices
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery...
USA – FDA recognizes three new international medical device software security standards
The US Food and Drug Administration (FDA) has recognized three new standards related to software security on medical devices. The standards address taking a...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
USA – Providing context to AI/ML products may address explainability says FDA
Context is important when trying to address issues of transparency and explainability of artificial intelligence and machine learning products (AI/ML), according to a regulatory...
USA – FDA eases UDI compliance requirements for some low-risk medical devices
The US Food and Drug Administration has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance...
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 – 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 – Legacy devices report highlights need for data to support future policies
More data is needed to understand the risks legacy connected medical devices pose to the healthcare system, particularly in their vulnerability to cyberattack. That...
