FDA
The Food and Drugs Administration (FDA), the US authority responsible for medical device regulation, has published a guidance document dedicated to the annual reports for Pre-market Approval Applications (PMA) that have been approved. Regulatory Background According...
FDA
The Food and Drug Administration (FDA) has published the draft guidance dedicated to the principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation. Scope of the guidance According to the...
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...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to providing regulatory submissions for medical devices in the electronic format under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Submissions in...
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