Greetings,
I understand that the FDA recognizes certain conformance standards, which may be included as part of a 510(k) submission. However, what if a company conforms to a standard that the FDA doesn't recognize, such as ISO 13485?
I've noticed that on the "Standards Data Report for 510(k)s" the FDA asks: "Is this standard recognized by FDA?"
Is a company required to delcare a non-recognized standard and prepare a report?
Regards, Tonia
I understand that the FDA recognizes certain conformance standards, which may be included as part of a 510(k) submission. However, what if a company conforms to a standard that the FDA doesn't recognize, such as ISO 13485?
I've noticed that on the "Standards Data Report for 510(k)s" the FDA asks: "Is this standard recognized by FDA?"
Is a company required to delcare a non-recognized standard and prepare a report?
Regards, Tonia