On May 7, 2001 FDA posted a standards recognition statement for use of the new ” ISO 14971:2000, Medical devices – Application of risk management to medical devices” which is at the link provided.

This statement indicates does not specify information that may be omitted from the 510(k) but instead says to check with the specific reviewing division for further guidance.

It does state the for Special 510(k)s conformance to this standard may satisfy the risk management portion.