AIM: Medtronic, St. Jude recalls illustrate why PMA modifications don't work

A new editorial in the Annals of Internal Medicine criticizes the premarket approval modification process, through which both Medtronic and St. Jude Medical released high-risk products that were later recalled.

Annals of Internal Medicine, Food & Drug Administration (FDA), Medtronic, St. Jude Medical

News Well, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Recalls, Regulatory/Compliance

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