CONFORM Clinical Trial Sites,

We’d like to inform you that a revised version (Rev L) of the Instructions for Use (IFU) for the CLAAS® AcuFORM™ Device is now available.

IFUs Rev E, J, and L were released for use in clinical sites.

• If your site uses WCG IRB and allows the sponsor to submit on your behalf, the IFU is WCG approved and available to you.
  
  

• If your site uses a local IRB or uses WCG and does not allow the sponsor to submit on your behalf, please submit IFU Rev L at your earliest convenience and work with your site manager to document the approval.

  • If your site currently utilizes IFU Rev E, please submit to your IRB both Rev J and Rev L (along with all attached redlines).
  • If your site currently uses IFU Rev J, please submit IFU Rev L (along with the attached redlines for J to K and K to L).

Attachments: (select the line item below to access and download, you can also find these on the Research Coordinator Portal/hub in the Protocol Section of the site.) 

• IFU Rev L clean
• IFU Rev J clean
• IFU Rev E to J redlines
• IFU Rev J to K redlines
• IFU Rev K to L redlines

Please contact your assigned Conformal Site Manager with any questions about this update.

Regards,

Aly Dechert   |   Manager of Clinical Operations 

Use the login:

AcuFORM2025!

Have suggestions or questions about this newsletter? 

Drop us a note at info@conformalmedical.com.