Just released from FDAnews — Investigations Operations Manual 2014 — the FDA’s own internal guidance on how to inspect a drug or device company. Know what the investigators look for — before they even get there.
Hugo Campos has a small computer buried in his chest to help keep him alive. But he has no idea what it says about his faulty heart. All the raw data it collects, especially any erratic rhythms it controls with shocks, goes directly to the manufacturer. And some of it later gets sent to his doctor. San Jose Mercury News