FDA releases updated guidance on pyrogen and endotoxin testing. Key clarifications for medical device and pharma manufacturers.

The FDA has issued final guidance on medical devices with indications associated with weight loss, outlining regulatory expectations for clinical studies, non-clinical testing, and benefit-risk evaluation.

FDA Recognition List 065 updates biocompatibility standards, including ISO 10993-4 Amendment 1 and multiple ASTM revisions. Impact for manufacturers.

The FDA has published a draft guidance adopting the ICH E22 guideline on Patient Preference Studies. Learn what this means for manufacturers involved in global development programmes.

FDA issues final guidance on cybersecurity in medical devices, outlining QMS, premarket documentation, and Section 524B requirements for manufacturers.

FDA implements Compliance Program 7382.850, aligning medical device inspections with the Quality Management System Regulation and ISO 13485.

The FDA has issued updated guidance on Clinical Decision Support (CDS) software, clarifying which software functions are excluded from the medical device definition under U.S. law.

The FDA has released a draft guidance outlining new clinical performance requirements for cuffless non-invasive blood pressure devices. Manufacturers using wearable sensors or AI must now meet specific testing standards, including ISO 81060-2. Learn how these updates affect premarket submissions and regulatory strategies.

FDA releases draft guidance on Bayesian methods in clinical trials. Learn how device manufacturers can benefit from this innovative approach.

New FDA guidance clarifies which Clinical Decision Support software functions are not considered medical devices. Key updates affect software developers and manufacturers.

The FDA has updated its guidance on low-risk general wellness devices, clarifying criteria for software, wearables, and lifestyle technologies that may fall outside device regulation. Effective January 6, 2026.

The FDA has finalized its 2025 guidance for sponsors on safety reporting in IND and BA/BE studies. Learn what manufacturers must update and how it affects your trials.

The FDA has released its final guidance on Computer Software Assurance (CSA) for production and quality system software, introducing a risk-based, streamlined approach to validating software used in manufacturing and quality operations. The updated framework helps manufacturers reduce unnecessary documentation, focus validation efforts on functions that impact product quality and patient safety, and accelerate the adoption of automated and digital technologies while remaining fully compliant with FDA requirements.

The FDA has issued a new draft guidance that updates the scientific principles for demonstrating biosimilarity. The document clarifies when strong analytical similarity data, supported by comparative human pharmacokinetic and immunogenicity assessments, may be sufficient to demonstrate biosimilarity without requiring a comparative clinical efficacy study. This updated approach can help manufacturers reduce development timelines and costs, while placing greater emphasis on robust analytical packages, sensitive PK study designs and a clear, risk-based justification aligned with FDA expectations.

The FDA has released a draft guidance aligning U.S. Quality Management System (QMS) requirements with ISO 13485:2016. This change simplifies compliance for medical device and IVD manufacturers and distributors, ensuring global harmonization and streamlined FDA premarket submissions effective February 2026.

The latest FDA guidance on decentralized clinical trials (DCTs) marks a significant development for IVD and medical device manufacturers. By incorporating digital health technologies, remote monitoring, and home-based device usage, DCTs allow for enhanced trial flexibility and patient accessibility. This guidance clarifies regulatory expectations, especially around investigational product distribution, informed consent, and oversight, supporting innovation while maintaining compliance.

A FDA lançou novas especificações técnicas para submissão de dados clínicos em leucemias agudas, definindo padrões rigorosos de qualidade e interoperabilidade.

A FDA publicou a orientação final sobre Garantia de Software Informático (CSA) para software de produção e sistemas de qualidade. Esta abordagem baseada no risco ajuda os fabricantes a garantir a conformidade, concentrar os esforços de validação onde são mais necessários e adotar tecnologias inovadoras, como automação, IA e sistemas em nuvem — melhorando, em última análise, a qualidade dos dispositivos médicos e a segurança dos pacientes.

A FDA publicou uma nova orientação sobre políticas de enforcement aplicáveis a testes de diagnóstico in vitro durante emergências de saúde pública, ao abrigo da secção 564 do FD&C Act. O guia define os critérios para o início e término destas políticas, oferecendo previsibilidade aos fabricantes em situações críticas, sem comprometer a segurança pública.

A FDA publicou a versão final do guia ICH E6(R3) sobre Boas Práticas Clínicas (GCP), que substitui a versão anterior e estabelece novos requisitos para ensaios clínicos. O documento reforça a abordagem baseada no risco, a integração tecnológica e a proteção dos participantes, promovendo qualidade, ética e harmonização internacional nos dados clínicos submetidos a processos regulamentares.