Thursday, August 7, 2014

FDA Further Eases Restrictions on Areas of Potential mHealth Innovation

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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