Radiation-Emitting Products

What criteria will FDA use to determine that facilities meet the MQSA requirements for dealing with patients with breast implants?

Policy Guidance Help System logo

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.

OR

2. having written procedures for inquiring, prior to the mammographic examination, whether the patient has breast implants.

Back to Breast Implants

Page Last Updated: 08/12/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.