PUBLICATIONS - 1996 edition of AAMI Standards and Recommended Practices, Volume 4:
This article was originally published in Clinica
A newly revised and expanded 1996 edition of AAMI Standards and Recommended Practices, Volume 4: Biological Evaluation of Medical Devices has been published. It costs $210 and is available from: AAMI, 3330 Washington Blvd, Suite 400, Arlington, VA 22201-4598, US. Tel: +1 (703) 525 4890. Fax: +1 (703) 276 0793.
You may also be interested in...
The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.
Attorneys tell Medtech Insight a recent proposal to review regulations every 10 years could lift some burdens from the medical device industry, but warned that the full effects may not be seen for some time.
A nasal spray formulated using compounds already approved by regulatory bodies in Europe and the US can “prevent and slow” transmission of COVID-19, according to UK researchers who are now seeking a partner to commercialize the product.