US Topic

Thema CORP, the US-based Thema subsidiary, is pleased to announce its recent membership in the Philadelphia Chamber of Commerce and LSPA, [...]

Last October 2023, the Food and Drug Administration (FDA) updated the Compliance Programme Manual on its official website, which covers inspections [...]

On October 2, 2023, the FDA  published an update to the Electronic Submission Template for Medical Device 510(k) Submissions guidance: Guidance for [...]

On August 11, 2023, the Food and Drug Administration (FDA) updated the Off-The-Shelf Software Use in Medical Devices guideline about Off-The-Shelf [...]

On 18 July 2023, the European Commission published in the Official Journal of the European Union the updated guideline Questions&Answers (Q&A) [...]

On 28 March 2023, the European Commission published in the Official Journal of the European Union the guideline Questions&Answers (Q&A) entitled [...]

On 22 September, FDA issued the Electronic Submission Template for Medical Device 510(k) Submissions, a document that provides specifications on electronic [...]

On 5 October, FDA published the Medical Device User Fee Amendments (MDUFA), a document containing updates on the registration fees for [...]

Despite MDR coming into force in 2017 and fully enforceable on 26 May 2021, it is still unclear for medical device [...]

The FDA is constantly recruiting personnel to test the Customer Collaboration Portal (CCP) functionality. This portal is already active to check [...]