Guidance for Request and Issuance of Interim Notice Letters for Mammography211 Facilities under the Mammography Quality Standards Act, 42 U.S.C. Section 263(b). 211 Guidance for Industry and FDA Staff

摘要

This guidance document reflects the agency's current thinking on the procedures211u001eto be used by FDA to issue, and by approved aucreditation bodies to request, 211u001einterim notice letters for mammography facilities, under the Mammography Quality 211u001eStandards Act of 1992 (MQSA or the Act). It does not create or confer any rights 211u001efor on any person and does not operate to bind FDA or the public. An alternative 211u001eapproach may be used if such approach satisfies the requirements of the 211u001eapplicable statute, regulations, or both. Enforcement of MQSA is presently 211u001egoverned by interim regulations at 21 CFR Part 900. Final regulations at 21 CFR 211u001ePart 900 will take effect on April 28, 1999. Both the interim and final 211u001eregulations, at section 900.11, require that mammography facilities by accredited 211u001eby an FDA approved accreditation body, in order to be certified by FDA to perform 211u001emammography.