FDA Eases the Way for New Product Development

Developers of new products have been wary of health-related applications, because if their applications are considered to be medical devices, time to market may be adversely affected by the regulatory process. “Medical devices are those items that are used in diagnosing, treating, mitigating, preventing or curing disease or conditions in humans. If you look at that definition, it’s pretty broad,” explains Bakul Patel of the FDA, in a May 2013 interview in the FierceMobileHealthcare.com weekly newsletter. Patel is the main author of the July 21, 2011 draft of the Guidance for Industry and FDA Staff advisory document ultimately issued more than two years later, on September 25, 2013, as follows: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf. Since devices help people monitor and manage their health problems, and improve fitness, the guidance scales back the definition “to allow innovation to happen in areas that are more beneficial to patients, while at the same time making sure patients have confidence and are not exposed to risk,” according to author Patel.

In July 2012, nearly one year after Patel’s draft of the Guidance document, Title VI of the FDA Safety and Innovation Act (FDASIA) was enacted, including Section 618, Health Information Technology (IT). Section 618(a) mandates that within eighteen (18) months, a strategy and recommendation on a risk-based regulatory framework pertaining to health IT, including mobile medical applications, that “promotes innovation, protects patient safety, and avoids regulatory duplication” be posted on the websites of the FDA, the FCC, and the ONC (Office of the National Coordinator for Health Information Technology) See FDASIA Title VI §618 on page 71 of


In April 2014, four months past the eighteen-month deadline, the FDA (with the FCC and ONC) released the report to Congress mandated by the FDASIA of 2012, http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM391521.pdf. This FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework is consistent with the intent and content of the earlier guidelines. The guiding principle is that the basis for oversight to control risks is a focus on functionality rather than current or future platform, technology, or product description. Using the ONC to promote safety and quality in the industry obviates increased FDA oversight. FCC authority is unchanged and still applies to everything that uses the radio frequency (RF) spectrum, plus any equipment that may emit RF energy, causing interference.

The FDASIA strategy categorizes health IT three ways: 1) administrative health IT functions, such as billing, scheduling, and inventory management 2) health management health IT functions, such as medication management, health information and data exchange, and patient identification, and 3) medical device health IT functions such as monitors with real-time alarms, diagnostics, and surgical planning and control. With ONC promoting quality measures and its recognition of existing and future industry quality and test standards, certifications, and accreditations, FDA oversight will extend over fewer and fewer “medical devices” as broadly defined. Even if the statutory definition of a medical device applies, many will not be regulated as such. These include wellness (as opposed to disease-related) devices, many medical device accessories, clinical decision support (CDS) software, and many medical device software modules. To illustrate this, consider that CDS such as duplicate testing alerts, drug dosing calculations, preventive care reminders, and drug-drug interactions, while quite important for patient safety, are tools used by skilled clinicians to support their work, and are not primarily responsible for patient safety. As such, “in applying a risk-based approach, FDA does not intend to focus its regulatory oversight on these products/functionalities, even if they meet the statutory definition of a medical device.” (p. 26)

The FDA still retains discretionary oversight for all “medical devices,” using the broadest definition. However, the rules may change, if the Legislature codifies and defines the third category of medical devices (real-time bedside monitor with alarm, robotic-aided surgery, etc.), limiting FDA oversight to these most direct and critical functional devices and health IT. The PROTECT Act in the Senate, and the SOFTWARE Act in the House are proposed bills which also apply the medical device/health IT functionality “triage,” that is, 1) health administration, 2) health management (including CDS), and 3) devices and software directly involved in the diagnosis and treatment of patients. In an email cited in the http://mobihealthnews.com April 4, 2014 blog by Jonah Comstock, attorney Bradley Merrill Thompson, “an FDA medical device regulation expert,” considered proposed legislation at the time to be “very sweeping in its regulatory scope,” but Thompson is of the opinion that the agencies (FDA,ONC,FCC), the Legislature, and people in industry largely agree, and “all three sectors are saying about 90 percent the same things. The bottom line is that the HHS, and the three agencies are proposing a very light touch to overseeing innovation in health IT, and that has to be good news for all of the HIT developers producing wonderful, important, cutting-edge new technologies.” http://mobihealthnews.com/31739/not-much-new-in-fdasia-report-congress-still-champing-at-the-bit/

This is good news for you innovators and product developers, reducing troubling uncertainties about regulatory obstacles that could discourage you, or scare off backers. Rather than using a regulatory process, many more health and medical products will come to market under the banners of quality management systems and industry standards. NPI Services, Inc. is ISO 13485 and ISO 9001 certified and is pleased to offer you quality work and individualized customer service to make your prototyping and lower-volume production processes quick and headache-free. As always, NPI Services offers you its entire suite of services, up to and including full turnkey, with the ease of one all-inclusive purchase order.