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Medical Devices / Regulatory Affairs

FDA Flags New Transparency Effort for Breast Implant Devices

May 6, 2019
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The FDA said breast implant manufacturers must file individual medical device reports (MDRs) that will be made publicly viewable in the Manufacturer and User Facility Device Experience (MAUDE) database.

The new requirement is part of a broader transparency effort that applies to all medical devices. Summary reporting was not previously allowed for unique or uncommon adverse events, including breast implant-associated anaplastic large cell lymphoma (ALCL).

“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” the agency said.

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