1 thought on “FDA Medical Device Approval: Is There a Better Way? (Part 2 of 2)

  1. To the patient-two choices #1 510(k) approved implanted device with no clinical study and some access to justice if the device fails or #2 PMA approval requiring clinical study but blocks access to state court if the implanted device fails. This stinks! The medical device industry business model should include a portion of profit to be put aside to compensate patients for failed "innovation". 30 minutes in: Vertical Group/Tornier/MedWatch Adverse Event#5009052 Surgeon financial interest.

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