Discussion:
The MQSA inspection program is required by law to be fee-supported. Effective October 1, 2007, the MQSA inspection fees for mammography facilities with one unit are $2,150 and $250 for each additional unit. For a follow-up inspection (if necessary), the fee is $1,144. Included in the fees are the costs associated with the scientific, administrative, and data system support for the mammography inspection program. The fees notice was published in the July 6, 2007, Federal Register (72 F.R. 37027). Any MQSA inspections conducted on or after October 1, 2007, are subject to these fees.
The total aggregate cost of the MQSA inspection program is estimated to be $15.77 million in FY 2008. The costs reflect the full-scale operation of an inspection program that utilizes State and FDA inspectors to annually inspect mammography facilities. Included are the costs associated with the scientific, administrative, and data system support for the mammography inspection program.
Facilities in Certifying States should contact their State Certifying Agency to determine the fees that apply to them. FDA will continue to assess its fee on facilities operating in approved Certifying States. This fee is $548.
The program is assessed annually to determine the adequacy of the fee. As noted in the Federal Register notice, FDA invites written comments from interested parties on its fee assessment procedures.
Governmental entities continue to be exempt from fee payment, and eligible mobile mammography providers continue to have the option of grouped inspections for a fee discount.Inspection Fee Consolidation
We encourage you and other interested parties to access our Internet Homepage (http://www.fda.gov/cdrh/mammography) to view and download a copy of the FR notice.
Related Topics:
Governmental Entity Declaration Form
Mobile Mammography Facility Inspection Fee Reduction Fact Sheet