Be sure you understand the investigator’s questions during an FDA inspection – and always ask for clarification if you are unclear, advised inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar.

Missouri-based Hi-Dow International, a manufacturer of transcutaneous nerve stimulators (TENS) units, received a form 483 for several repeat observations of failure to establish proper complaint procedures, lack of design controls, and inadequate procedures for corrective and preventive actions, among other lapses.

Neuro20 Technologies has received FDA clearance for its wearable Neuro20 PRO suit that contracts muscles to help correct habits that were formed in response to old injuries.

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Israel-based Theranica Bio-Electronics’ Nerivio remote electrical neuromodulation (REN) device can now be used as a preventive treatment for migraine, having received an expansion of its de novo marketing clearance the FDA granted in 2019 for acute migraine treatment.

The FDA has enrolled four devices in its Total Product Life Cycle Advisory Program (TAP) pilot, which is designed to give faster, more widespread access to medical devices of public health importance and strengthen the agency’s Breakthrough Devices program.

The FDA’s latest updates to its Electronic Medical Device Reporting (eMDR) system will go live on March 17, making five changes to the online system devicemakers and importers must use to submit MDRs.