What You Need to Know About USP 661 Series on Plastic Packaging
The USP-NF is a combination of two compendia: the United States Pharmacopeia (USP) and the National Formulary (NF). When USP-NF set out to revise General Chapter <661>, Containers-Plastics in 2013 [published in Pharmacopeial Forum/PF 39(5)], one stated goal was to increase flexibility by going from prescribed tests and limits to a model where the drug manufacturer could apply tests based on risks associated with the packaging’s Materials of Construction (MoC) and the drug product dosage form.
FDA under fire: Pared-down LDT Final Rule leaves unanswered questions
The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs).
The Role of EPSS in Prioritizing IoMT Security Threats
The Exploit Prediction Scoring System (EPSS) can help healthcare organizations prioritize security vulnerabilities, but it has limitations in IoMT environments. While EPSS provides valuable data-driven prioritization, it should be combined with other risk assessments, cybersecurity frameworks, and strategies to more comprehensively secure healthcare systems’ IoMT devices.
Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions
In the Quality Management System Regulation final rule issued today, the FDA is amending the title of the regulation, and establishing requirements and provisions that clarify certain expectations and concepts used in ISO 13485:2016. The revised part 820 is referred to as the Quality Management System Regulation (QMSR).
How Pharmaceutical Companies Can Leverage Smart Labels
Every medical professional wants patients to take their […]
3D-printed Lens Implant Could Revolutionize Cataract Surgery
A mixture of photopolymerizable materials developed by researchers in England combined with 3D printing could revolutionize cataract surgery.
The Importance of USP Class VI Testing
The United States Pharmacopeia (USP) group is a non-gov […]
A Checklist: Top 10 Considerations in Choosing a Medical Device Contract Manufacturer
The global medical device outsourcing market size was estimated at $128.8 billion in 2023 and is anticipated to grow 12.8% per year from 2024 to 2030. For many medical device manufacturers (OEM), the only way to compete in this growing market is to outsource part, or sometimes all, of their design, prototyping, supply chain management, manufacturing, assembly, testing, and packaging to a qualified contract manufacturer.
FDA Outlines its Approach to Artificial Intelligence Regulation
U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work among multiple departments within the FDA. On March 15, the FDA released “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines how the agency’s medical product centers plan to address the efforts required to protect public health while fostering responsible innovation in AI used in medical products and their development.
Component Selection Considerations for Sensor-Driven Medical Devices
ompanies introducing new sensor-driven technology into the biosensor market must make careful, strategic decisions during the design phase if their products are to compete with established players. Often lost in the excitement of burgeoning product ideas is the need for component compatibility, but this is a critical consideration that significantly impacts market viability.
