USA: FDA has increased fees for 2022 fiscal year by 2.5%
The US Food and Drug Administration (FDA) has published the fee rates corresponding to fiscal year 2022 (FY2022) starting October 1st [...]
21 09 2021
21 09 2021
04 08 2021
04 08 2021
EU: first MDR and IVDR harmonised standards published
In July 2021, the first MDR and IVDR harmonised standards were published in the Official Journal of the European Union. Harmonised [...]
27 04 2021
27 04 2021
USA: CDRH announces new Biocompatibility Assessment Resource Center
Last month, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced the new electronic Biocompatibility Assessment [...]
22 02 2021
22 02 2021
USA: exemptions from Premarket Notification 510(k) requirements for some Medical Devices
In order to increase the availability of certain Medical Devices in contrast to the COVID-19 health emergency, on January 15, 2021 [...]
05 08 2020
05 08 2020
USA: FDA guideline on electronic format sending for Medical Devices
The FDA guideline “Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, [...]
24 07 2017
24 07 2017
USA: updated the post-market surveillance guideline for class 2 and class 3 devices
On May 16, 2016 the FDA published the updated guideline “Postmarket Surveillance under section 522 of the Food, Drug and Cosmetic [...]
