What criteria will FDA use to determine that facilities meet the MQSA requirements for dealing with patients with breast implants?
The requirements for dealing with patients with breast implants can be met by:
1. demonstrating to the MQSA inspector that the facility has asked its patients whether they have breast implants. This may be done by showing patient information forms that have this question answered.
2. having written procedures for inquiring, prior to the mammographic examination, whether the patient has breast implants.