Latest FDA strategic guideline
In September 2020 FDA published some “Final Guidance Document” for companies operating in Medical Devices field. Latest FDA strategic guideline Published [...]
03 11 2020
03 11 2020
03 11 2020
03 11 2020
FDA: 7% fees increase for 2021
FDA has published fee schedule for the 2021 fiscal year (FY 2021) from October 1, 2020 through September 30, 2021, providing [...]
03 11 2020
03 11 2020
COVID-19: FDA actions to fight the pandemic continue to be carried out
In recent days, the United States has registered record data on Coronavirus infections. Over 500 thousand cases in one week. The [...]
29 06 2020
29 06 2020
FDA guide on non-binding feedback request after inspection
The FDA guide “Nonbinding Feedback After Certain FDA Inspections of Device Establishments” explains how an owner, operator or agent responsible for a [...]
29 06 2020
29 06 2020
FDA: EUA authorisations for Medical Devices during COVID-19
FDA has issued exceptional emergency use authorisations (EUA) to ensure that patients and healthcare professionals have timely and continuous access to [...]
06 03 2020
06 03 2020
Coronavirus and Medical Devices: actions implemented by FDA
Food and Drug Administration (FDA) is working extensively to prevent the possible consequences of the spread of Coronavirus (COVID-19) in relation [...]
06 03 2020
06 03 2020
USA: list of Class I and Class II devices exempt form pre-market notification 510 (k)
On Decembre 30, 2019 the Food and Drug Administration (FDA) published a list of Class I and Class II Medical Devices [...]
06 03 2020
06 03 2020
USA: FDA’s Regulatory Agenda for 2020
Last November 2019 the Food and Drug Administration (FDA) published the regulatory activities planned for 2020. In January 2020 FDA wished [...]
30 10 2019
30 10 2019
FDA updates list of recognized standards for medical device premarket reviews
Modifications to the initial list of recognized standards were announced on October 24, 2019, when the latest list of recognized standards [...]
30 10 2019
30 10 2019
FDA’s stance on regulating digital health products
To keep up with the ever-evolving software applications intended for use on mobile or on general-purpose computing platforms and their potential [...]
