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Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, biostatistics experts took to JAMA to discuss the benefits and potential pitfalls of FDA’s recent draft guidance on Bayesian methods, FDA published a report on its GDUFA science program, and the agency released its OMUFA facility fee rates for FY 2026.

Groups representing drugmakers and combination product manufacturers have asked the US Food and Drug Administration (FDA) for more clarity on its recently published draft guidance on the use of cross-center master files (MF). More specifically, they asked how the agency will address master file deficiencies, communication between product centers and sponsors, center responsibilities, and more.

BRUSSELS – The European Commission's proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) include specific changes to the regulation of medical device software, including medical device artificial intelligence (AI), in Europe. According to experts who spoke at the 2026 DIA-RAPS Combination Products in the EU conference, the proposed changes would clarify how the products are classified and could delay the implementation of the EU Artificial Intelligence (AI) Act.

Medical device makers must comply with the US Food and Drug Administration's (FDA) Quality Management System Regulation (QMSR) after the rule took effect on Monday. Additionally, FDA inspections of device facilities will no longer be conducted under the prior Quality System Inspection Technique (QSIT) and instead will be carried out in accordance with a new compliance program manual.

BRUSSELS – European Commission officials say they have proposed legislative changes to the European Parliament that they hope will ease regulatory requirements for sponsors of combined studies based on ongoing pilot projects.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

PROVIDENCE, RI – The head of the US Food and Drug Administration's (FDA) Office of Combination Products (OCP) said the agency has heard industry's concerns about its draft guidance on essential drug delivery outputs (EDDOs). While there is no deadline to issue a final version, he said the agency is taking the feedback to heart as they work on the final guidance.

PROVIDENCE, RI – A US Food and Drug Administration (FDA) official said that predetermined change control plans (PCCPs), while not required, can reduce the need to submit supplemental applications for medical devices and device-led combination products that incorporate artificial intelligence (AI).

PROVIDENCE, RI – The US Food and Drug Administration's (FDA) recently released trove of complete response letters (CRL) is a valuable resource for companies to understand the agency's thinking on human factors. A panel of experts say that they have used the documents to evaluate human factors of their own products and avoid potential regulatory pitfalls.

PROVIDENCE, RI – Despite significant changes at the US Food and Drug Administration (FDA) over the past year, the agency's top combination products regulator says that work at his office has mostly continued business as usual.

The US Food and Drug Administration (FDA) has released a new final guidance on preparing a pre-request for designation (Pre-RFD) with the Office of Combination Products (OCP), that contains information on best practices for engaging with OCP in the Pre-RFD process.

PITTSBURGH — Experts acknowledged significant differences in the US and EU approaches to regulating combination products and called for greater collaboration and use of harmonized standards by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Several stakeholders have raised concerns that parts of the US Food and Drug Administration's (FDA) draft guidance on unique device identifier (UDI) requirements for combination products are inconsistent with UDI regulations. They also raised concerns that several aspects of the guidance are ambiguous and would create confusion for manufacturers.