I recently reviewed the timeline for FDA regulation of mobile apps and devices and shared my perspective on the path forward. At the time, I was unaware of another recent draft document released by the FDA on August 1, 2014 explaining their "Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements." Given that the devices listed in this document have been targets for mHealth innovation, this is a positive development for the industry.
The document lists devices in the following categories (items currently relevant in mHealth are emphasized, this is not a complete list):
- Anesthesiology Devices
- algesimeters, NO2 analyzers, cutaneous O2 monitors, pneumotachometers, rocking beds, portable air compressors
- Cardiovascular Devices
- trocars, lung sound monitors, oscillometers, body composition analyzers
- Dental Devices
- pulp testers, denture pads/cushions/reliners, plastic dentures, endodontic splits, parallelometers, teething rings
- Ear, Nose & Throat Devices
- hearing aids, middle-ear molds
- Gastroenterology - Urology Devices
- fiberoptic/endoscopic light sources, colostomy rods, hemorrhoidal/esophageal ligators, biliary lithotriptors, urethrotomes, esophageal dilators, ostomy irrigators
- General and Plastic Surgical Devices
- alcohol pads, talking first aid kits, surgical drapes/lights
- General Hospital and Personal Use Devices
- electrical thermometers, support stockings, finger cots, UV water purifiers, patient restraints
- Neurological Devices
- vibration threshold devices, temperature discrimination testers, ataxiagraphs, preformed cranioplasty plates
- Obstetrical and Gynecological Devices
- fertility diagnostic devices, cervical drains, obstetrical forceps, vaginal specula, umbilical clamps, perineal heaters, menstrual cups/pads, genital vibrators
- Ophthalmic Devices
- ophthalmic cameras, photorefractors, euthyscopes, transilluminators, trephine engines, electrolysis units, headlights/lamps, magnets, sponges
- Physical Medicine Devices
- reflex hammers, finger-sucking devices, hydro-massage baths, sitz baths, paraffin baths, measuring exerciser, external limb overload warning devices
Given that mHealth regulation will likely require increased resources, this notably has the potential to free-up resources in the low-risk device categories arena so that the FDA can focus on high-risk devices and applications.
I applaud the FDA for their consideration and attention to this area.
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