My company is a newly established Medical Devices manufacturer. We are currently looking to produce Safety Lancets for US, Europe and China market. I would like to know anybody got any idea what is the testing standard used for lancets, and do we need to carry out biocompatibility study as it is a Class I product in FDA list?

Thank you in advance. :eek:

1) Check the list of consensus standards on http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

2) If the material is already used in similar applications, you may not need to perform Biocompatibility studies.

You mabe able to glean some more information by researching 510k summaries for similar devices at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

You can then order the 510ks under the Freedom of Information Act.

Hope this helps.