FDA

The FDA has a clear regulatory framework for AI-assisted medical decision-making tools, classifying them as Software as a Medical Device (SaMD).

2023年FDA发布了AI/ML药物开发讨论文件，但仅是初步探索

The FDA's Adverse Event Reporting System (FAERS) receives approximately 500,000 to 600,000 adverse event reports per quarter.

美国FDA已于2023年发布专项指南，认可合成医疗数据在特定条件下的监管有效性

FDA Modernization Act 2.0 并非禁止动物实验，而是允许药企在获得 FDA 认可的前提下，使用基于人类细胞的替代方法（如类器官、器官芯片、计算机模型等）来满足安全性评估要求。

The U.S. FDA has not yet issued specific guidance for biological clock testing products, and under the EU IVDR framework such kits are mostly managed as in vitro diagnostic devices, requiring analytical performance and clinical performance evidence.

As of now, no hemoglobin-based oxygen carrier (HBOC) has received full FDA approval for clinical use in the United States.

Second Sight's Argus II was the first FDA-approved retinal prosthesis, launched in 2013 and later withdrawn from the market in 2019.

Nothing in the prototype system has obtained FDA clearance, and the verification layer is a research tool.

Kanoski's lab gave mice three sweeteners (stevia, acesulfame potassium, saccharin) from adolescence to adulthood, at doses within the FDA acceptable daily intake, and found memory deficits and changes in glucose regulation in adulthood, including a larger insulin peak.

Regulatory agencies such as the US FDA typically require single-enantiomer drugs to have an ee value of 99% or above.

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) generally require chiral drugs to provide pharmacological and toxicological data for each enantiomer, and single-enantiomer products of many chiral drugs need to reach an ee value of more than 99% to be approved for marketing.

FDA issued updated medical device cybersecurity guidance in February 2026, covering cybersecurity design and premarket documentation requirements.

The FDA's Quality Management System Regulation (QMSR) officially takes effect on February 2, 2026.

In its 2023 cybersecurity guidance, FDA explicitly requires medical device manufacturers to submit an SBOM (Software Bill of Materials) prior to market approval.

The FDA has designated psilocybin as a Breakthrough Therapy, allowing for an expedited review process

Regulatory agencies (such as the FDA and NMPA) are increasingly inclined to require prospective evidence when approving clinical AI products.

The U.S. FDA and EU MDR approval requirements for AI medical devices include performance validation, bias assessment, and post-market surveillance.

The U.S. FDA has issued multiple warnings noting that kratom-related products have been associated with hundreds of adverse reactions and even deaths.

The UVA/Padova model (also known as the FDA-accepted Type 1 Diabetes Metabolic Simulator, T1DMS) is the most representative simulator of T1DM patients.