FDA Digital Mammography Inspection Addendum

FDA published a policy addendum: ” The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13″ that mentions software in several places. It refers to software generated reporting and its usage by the facility but does not indicate such software is to be treated as a medical device. It also identifies some special issues with the foot pedal sensor software algorithms in such devices. . The full policy addendum is at the link provided.

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