• Regulatory NewsRegulatory News

    FDA Proposes Major Changes to Mammography Regulations

    The US Food and Drug Administration (FDA) on Wednesday proposed a new rule that would modernize mammography regulations and require mammography facilities to provide patients with more information on breast density. The changes come as, according to the National Cancer Institute (NCI), about 12.4% of women will be diagnosed with breast cancer at some point during their lifetime. In 2018, more than 260,000 women were diagnosed with breast cancer and more than 40,920 wome...
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    FDA Finds Widespread Process Deficiencies at Mammography Facilities

    The US Food and Drug Administration (FDA) says that nearly half of all mammography facilities inspected in the first six months of 2017 had at least one deficiency under a new inspection program aimed at improving image quality, according to data released by the agency on Friday. In January, FDA launched the initiative, referred to as EQUIP (Enhancing Quality Using the Inspection Program), aimed at identifying process and systems related deficiencies at mammography facil...
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    Mammogram Record Retention: FDA Offers Advice

    Following some confusion over mammogram record retention requirements, the US Food and Drug Administration (FDA) on Thursday told all facilities conducting such tests that they must retain a record of each one for at least five years, or not less than 10 years if no additional mammograms of the patient are performed at the facility (or a longer period if mandated by state or local law). Under the Mammography Quality Standards Act (MQSA), original mammograms and their r...
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    FDA Releases Draft Guidance on Displays Devices for Diagnostic Radiology

    The US Food and Drug Administration (FDA) released a new draft guidance intended to clarify the information device makers should include in their 510(k) submissions for displays used in diagnostic radiology. These devices are used to display, store, transfer or process medical images and are commonly used by radiologists to make diagnoses. Display devices are systems that use liquid crystal display (LCD) and light-emitting diode (LED) technology to display images in comb...
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    Screen-Film Mammography Will Soon be ‘Virtually Obsolete,’ FDA Says

    As quality issues with screen-film mammography continue to crop up, the US Food and Drug Administration (FDA) says facilities are almost done transitioning to full field digital mammography (FFDM) units 15 years after they came into clinical use. Currently, fewer than 400 screen-film units are in use at 5% of the facilities certified under the Mammography Quality Standards Act (MQSA). And although this represents just a sliver of the total mammography units in operation...