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.
The FDA granted 510(k) clearance to NanoVibronix to market its PainShield MD diathermy device. The product consists of a disposable patch connected to a portable, reusable driver and generates ultrasound waves to the desired area of the body. The device treats pain locally in conditions such as tendonitis, other musculoskeletal disorders and post-operative pain, the company said.