devices—a broad category which encompasses everything from artificial
hearts, to tongue depressors, to blood tests—is more tailored and is graduated
on the basis of risk, with the highest-risk devices (like the artificial heart)
subject to full premarket approval procedures and the lowest-risk devices
(like tongue depressors) subject only to “general controls,”
reporting and adherence to good manufacturing practices.
By contrast, the FDA has largely avoided regulating traditional mobile
38 opting most importantly only to regulate apps “whose
functionality could pose a risk to a patient’s safety if the mobile app were not
to function as intended.”
39 As in the case of traditional medical devices, the
FDA’s oversight here is risk-based. The FDA has provided a number of
examples of apps which pose a “lower risk” to the public and, therefore, over
which it has decided to exercise enforcement discretion for the time being.
FDA regulation is often viewed by industry leaders as a hindrance to be
surmounted—a process that adds time and expense to the development of a
new medical technology, and is therefore a drag on innovation, not an
incentive in the way that patents are.
41 However, inherent in the FDA’s ability
to oversee the approval process is the ability to demand the development and
dissemination of information about new medical technologies.
Becky Eisenberg has most notably made this argument in the context of
pharmaceuticals, arguing that FDA regulation valuably promotes the
36. 21 U.S. C. § 360c(a)( 1)( C) (2012); Replacement Heart Valve, 21 C.F.R. § 870.3925
(2015); 21 U.S. C. § 360c(a)( 1)( A) (2012); Tongue Depressor, 21 C.F.R. § 880.6230 (2015).
38. William M. Sage, Assembled Products: The Key to More Effective Competition and
Antitrust Oversight in Health Care, 101 CORNELL L. REV. 609, 698–99 (2016); see also Mark
Sullivan, FDA Makes Official Its Hands-Off Approach To Regulating Health Apps and
Medical Software, VENTUREBEAT (Feb. 6, 2015), http://venturebeat.com/2015/02/06/fda-
39. U.S. FOOD & DRUG ADMIN., MOBILE MEDICAL APPLICATIONS: GUIDANCE FOR
INDUSTRY AND FOOD & DRUG ADMINISTRATION STAFF, 4, 20–21 (Feb. 2015),
http://www.fda.gov/downloads/MedicalDevices/. . ./UCM263366.pdf. As a note, the FDA
has also declined to regulate apps it does not deem “medical devices.” Specifically, the FDA
has designated a set of apps that it does not consider to be “medical devices” under the
statutory definition. These include apps that provide physicians access to electronic copies of
medical reference books, apps that are used for physician or patient training and education, or
apps that automate hospital processes like billing and shift management, to name a few. These
carve-outs were subsequently codified in large part in the 21st Century Cures Act. See 21st
Century Cures Act, Pub. L. No. 114-255, § 3060 (2016).
40. U.S. FOOD & DRUG ADMIN., supra note 39, at 23–26.
41. INST. OFMED. OF THE NAT’L ACADS., PUB. HEALTH EFFECTIVENESS OF THE FDA
510(K) CLEARANCE PROCESS 20–22 (Theresa Wizemann ed. 2010).
42. Rebecca S. Eisenberg, The Role of the FDA in Innovation Policy, 13 MICH.
TELECOMM. & TECH. L. REV. 345, 347 (2007).