Medical Device

Drug versus Medical Device eLearning Course Now Available for Purchase!

5/13/2019

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Many people automatically think about drugs when they visualize clinical trials, especially if that has been their experience. Medical devices are essential for human health and it is important to understand how they are distinct from drugs. Although there are similarities, there are quite a few differences between medical device and drug or biologic clinical trials, including:

Changes to ISO 14155 Medical Device GCP

4/16/2019

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The International Organization for Standardization (ISO) is a network of national standard bodies that develop voluntary standards, some which are applicable in the clinical research field. Some countries or organizations adopt ISO standards as requirements. ISO standards are reviewed every five years, and it takes approximately three years to develop a new standard.

One important standard in clinical research is ISO 14155.

Steps to Modernization of 510(k) Device Approvals

1/2/2019

The Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH) have announced efforts to modernize the 510(k) clearance pathway for medical device approval. Device manufacturers more frequently use the 510(k) pathway than other pathways to market. To gain market approval under 510(k), the manufacturer demonstrates that their device is substantially equivalent to an already marketed, or predicate, device. The 510(k) pathway is faster and easier than for devices that have no predicate. Modern devices are more technologically advanced than devices from even ten years ago. Because of its reliance on existing devices, there are concerns that following the 510(k) pathway may inhibit advancements in technology.

Final Rule Updates and Clarifies Medical Device Classification

12/18/2018

The U.S. Food and Drug Administration (FDA) published a Final Rule to the Federal Register on December 17, 2018. It will update 21 CFR 860: “Medical Device Classification Procedures” and will implement changes required by the 2012 FDA Safety and Innovation Act’s (FDASIA) amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act).