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...
Australia and Oceania
The Therapeutic Goods Administration (TGA) provided a set of detailed guidance documents to assist medical device manufacturers in achieving and sustaining compliance with regulatory requirements to be allowed for marketing in Australia – the Australian...
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The Food and Drug Administration (FDA) has published the draft guidance dedicated to the principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.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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