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US Food and Drug Administration Novel Healthcare Devices and Apps: A Microreview

Advances in Skin & Wound Care: December 2016 - Volume 29 - Issue 12 - p 534
doi: 10.1097/01.ASW.0000508380.85110.18
DEPARTMENTS: EDITORIAL
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Richard “Sal” Salcido, MD, EdD, is the Editor-in-Chief of Advances in Skin & Wound Care and the William Erdman Professor, Department of Physical Medicine and Rehabilitation; Senior Fellow, Institute on Aging; and Associate, Institute of Medicine and Bioengineering, at the University of Pennsylvania Health System, Philadelphia, Pennsylvania.

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The advancing array of biomedical technologies developed by medical device manufacturers include, but are not limited to, the use of microchip technology that readily adapts to computer-driven miniature motors, sensors, actuators, and transducers. In addition, these small technologies comprise parts of medical devices, including “flexible robots” and sensors that are woven into fabrics and smart dressings.1,2 It is now commonplace to couple the driver for these devices into “smart phones” or tablets.

The miniaturization of computers allows for “point-of-service” application. Cell phones and mobile (handheld) devices are no longer limited to communication; they now incorporate computational devices specifically designed not only to drive but also to control healthcare applications (devices). These small devices now have the capability of using data collected from cameras, ultrasound, and near-infrared scanners. Specifically, in the wound care realm, there are opportunities to monitor wound healing in real time and even measure treatment outcomes. The Food and Drug Administration (FDA) categorizes the devices under the following framework3:

  • Mobile platforms (handheld), commercial off-the-shelf computing platforms, with or without wireless connectivity. Examples include smart phones, tablet computers, or other portable computers.
  • Mobile application (app) is defined as a software application that can be executed (run) on a mobile platform (ie, commercial off-the-shelf) or a web-based software application that is tailored to a mobile platform but is executed on a server.
  • Mobile medical app: For purposes of this guidance, a “mobile medical app” meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act and is intended to be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device.

The FDA guidance document for medical mobile apps and indications for regulatory approval was updated in February 2015.3 In general, the FDA regulates those apps that meet the definition of a medical device and that pose a risk to patient safety if they do not function as intended. Medical apps that provide medical information or content are generally not required to seek regulatory approval. However, medical apps that incorporate diagnostics or primary prevention and disease prevention recommendations are generally subject to individualized FDA enforcement discretion. If those devices measure healing and/or capture diagnostic images, they can be subject to disclosure in a medical malpractice case, especially if they cause or document a safety risk. The FDA now encourages input about these devices from the end user as well—the patient.4

The application/approval 510(k) process for mobile device and mobile medical app developers is much shorter than the application/clearance process for medical devices, with most 510(k) submissions cleared within 1 year.5

We are beginning to see more handheld wound care diagnostic devices published in our journal and other peer-reviewed media, including the following examples:

  • FDA-approved “Scout”—an image capture device (WoundVision, LLC, Indianapolis, Indiana) to measure wound length and width and wound perimeter.6
  • A handheld, Portable Real-time Optical Detection Identification and Guide for Intervention (MolecuLight, Toronto, Ontario, Canada) that enables noncontact, real-time, high-resolution visualization and differentiation of key pathogenic bacteria through their endogenous autofluorescence, as well as connective tissues in wounds.7
  • An ultraportable near-infrared optical scanner has been developed at the Optical Imaging Laboratory that can perform noncontact 2-dimensional area imaging of the wound site.8 This research was supported by the National Institutes of Health (R15CA119253) and Florida International University Division of Research, Miami, Florida.

This month’s continuing education article (page 567) gives us a systematic review and meta-analysis on the efficacy of monitoring devices in support of prevention of pressure injuries.

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References

1. Ochoa M, Rahimi R, Ziaie B. Flexible sensors for chronic wound management. IEEE Rev Biomed Eng 2014;7:73–86.
2. Axisa F, Schmitt PM, Gehin C, Delhomme G, McAdams E, Dittmar A. Flexible technologies and smart clothing for citizen medicine, home healthcare, and disease prevention. IEEE Trans Inf Technol Biomed 2005;9:325–36.
3. Mobile Medical Applications, Guidance for Industry and Food and Drug Administration Staff Document, February 9, 2015. www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf. Last accessed October 24, 2016.
4. Hunter NL, O’Callaghan KM, Califf RM. Engaging patients across the spectrum of medical product development: view from the US Food and Drug Administration. JAMA 2015;314:2499–500.
5. Saxon LA. Mobile health application solutions. Circ Arrhythm Electrophysiol 2016;9(2):e002477.
6. Langemo D, Spahn J, Spahn T, Pinnamaneni VC. Comparison of standardized clinical evaluation of wounds using ruler length by width and Scout length by width measure and Scout perimeter trace. Adv Skin Wound Care 2015;28:116–21.
7. DaCosta RS, Kulbatski I, Lindvere-Teene L. Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results. PLoS One 2015;10(3):e0116623.
8. Lei J, Rodriguez S, Jayachandran M, et al. Quantitative wound healing studies using a portable, low cost, handheld near-infrared optical scanner: preliminary sensitivity and specificity analysis. Proc SPIE 9699, Optics and Biophotonics in Low-Resource Settings II, 96990S (March 7, 2016).
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