FDA & “Certain Devices” with Intact Skin Contact – Draft Guidance Assessment
The human body’s biggest organ is the skin. It is also our best organ because it keeps the outside out and our insides in. Yet, despite its remarkable toughness and...
New Guidance on FDA ISO 10993-1
On 4 September 2020 FDA re-issued their guidance on the use of ISO 10993-1 and Biocompatibility. I don’t think anyone saw this coming. It’s a big surprise! But the good...
Chemical Characterisation – no simple matter
Understanding Chemistry is now mandatory The most recent edition of ISO 10993-1 in 2018 added to the evaluation table (Table A.1) the interesting item “Physical and/or chemical information.” This is...
