FDA
The Food and Drug Administration (FDA), the US regulating authority, has published guidance describing technical considerations for non-clinical assessment of medical devices containing nitinol. The present document constitutes a final version of the draft guidance...
FDA
The Taiwan Food and Drug Administration (FDA) has published technical guidelines for medical device software inspection and registration of Artificial Intelligence and Machine Learning technology. The new approach is based on the regulations adopted in the United...
North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
North America
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the following three categories: Class I, Class II, and...
Europe
Over the last two decades, biologics have revolutionized the treatment of illnesses such as diabetes, cancer, rheumatoid arthritis and hepatitis. However, many prominent biologics are about to have their patents expire in the U.S., making way for biosimilars....
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
