Regulatory Focus™ > News Articles > FDA Establishes Class II Controls for Full Field Mammography System

FDA Establishes Class II Controls for Full Field Mammography System

Posted 28 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released new guidance on 27 March establishing Class II Special Controls for full field digital mammography systems (FFDMS), bringing the device class under the 510(k) approval pathway.

The guidance, Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System, includes advice on the evaluating risks to human health, electrical safety precautions, biocompatibility, physical device testing, clinical image evaluation and device labeling.

According to FDA, a manufacturer who intends to market a device of this generic type must:

  • conform to the general controls of the Federal Food, Drug and Cosmetic Act, including the premarket notification requirements described in 21 CFR 807 Subpart E
  • address the specific risks to health associated with full-field digital mammography devices identified in this guidance
  • obtain a substantial equivalence determination from FDA prior to marketing the device. (See 21 CFR 807 Subpart E, including 21 CFR 807.81 and 807.87)


Read more:

FDA - Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System


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