FDA
The Food and Drug Administration (FDA) has proposed an amendment to the non-invasive bone growth stimulators classification rules. The document has been published in the Federal Register. Non-Invasive Bone Growth Stimulator Devices: Brief Description Non-invasive bone...
FDA
The Food and Drug Administration (FDA), the US medical device regulating authority, has published a notice dedicated to the pilot program for a request for designation (RFD) and pre-request for designation (Pre-RFD) electronic submissions. The document was published...
North America
The US Food and Drug Administration (FDA), the authority responsible for medical devices regulation, issued guidance dedicated to 510(k) premarket notification submissions for Electrosurgical devices for general surgery. The scope of the document covers devices based...
South America
Argentina informs about more upcoming changes in their medical device registration procedures. The appropriate amendments would be implemented in two consecutive steps: on March 6, 2020, and on March 16, 2020, respectively. In particular, the amendments are set forth...
Uncategorized
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulations, issued detailed and exhaustive research dedicated to the timeframes of procedures related to the medical device registration process describing the typical...
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