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FDA AI Software Classification 2026: Class II and PCCP Rules for Imaging Devices
On June 17, 2026, the US FDA finalized a new Class II classification for radiological machine learning-based quantitative imaging software. This epis…
3 months, 4 weeks ago
Brazil ANVISA SaMD Regulation Update: Preparing for Changes to RDC 657/2022
Brazil's health agency, ANVISA, has announced its 2026-2027 regulatory agenda, which includes a significant revision to the rules for Software as a M…
3 months, 4 weeks ago
Singapore HSA's 2026 Medical Device Grouping Guidance: Key Changes in GN-12-1-R3
Singapore's Health Sciences Authority (HSA) released its updated guidance on medical device grouping, GN-12-1-R3, on June 2, 2026. This episode provi…
4 months ago
Australia TGA UDI Deadline: Class III & IIb Device Compliance by July 1, 2026
Australia's Therapeutic Goods Administration (TGA) is enforcing its first major Unique Device Identification (UDI) deadline on July 1, 2026. This epi…
4 months ago
Japan PMDA SaMD Guidance: Key Changes from the June 2026 Update
On June 5, 2026, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) updated its core guidance for Software as a Medical Device (SaMD). This ep…
4 months ago
FDA AI Medical Device Guidance 2026: New Rules for Transparency and Lifecycle Management
This episode breaks down the US FDA's new draft guidance on AI-enabled medical device software, released on June 6, 2026. We explore the FDA's strict…
4 months ago
FDA Payor Communications Guidance 2026: What Medical Device Manufacturers Need to Know
The US FDA's June 3, 2026 draft guidance on manufacturer communications with payors marks a significant policy shift for the medical device industry.…
4 months ago
FDA 510(k) Exemption for Unclassified Devices: New June 2026 Guidance
The US FDA has released a new final guidance, effective June 4, 2026, exempting certain unclassified medical devices from 510(k) premarket notificati…
4 months ago
EU AI Act & Medical Devices: Deadline Extended to 2028 for High-Risk Systems
The European Union has extended the compliance deadline for the AI Act for high-risk medical devices and IVDs already regulated by the MDR and IVDR. …
4 months ago
FDA 510(k) Exemption Guidance 2026: Five New Product Codes Exempted
The US FDA issued a final guidance on June 4, 2026, immediately exempting five unclassified medical device product codes from 510(k) premarket notifi…
4 months, 1 week ago