Abstract
This chapter introduces basic legal concepts in medical device regulation; FDA’s organization with respect to medical device regulation; different types of FDA documents which Digital Health Entrepreneurs (“DHE”s) may encounter; the routes by which medical devices (including DHPs) enter the market; product classification; basic elements of FDA pre-market submissions; and, finally, restrictions on marketing and advertising of which DHEs must be aware. We try to provide examples, along the way, of actual digital health products to illustrate different points in the discussion.
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Notes
- 1.
https://www.fda.gov/MedicalDevices/DigitalHealth/default.htm, last accessed September 2, 2018.
- 2.
Discussed below.
- 3.
FDA very rarely initiates criminal enforcement proceedings. It is far more likely that the agency will demand a product’s removal from the market or require a company to change its manufacturing or marketing approach. Any of these can cause the company’s revenue to fall, jeopardizing both future growth and future outside investment.
- 4.
J Ronquillo and D Zuckerman, “Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health,” Milbank Quarterly Vol. 95, Issue 3 (pp. 535–553) (September 12, 2017).
- 5.
Sanctions take many forms, including but not limited to the seizure, detention or registration revocation of medical devices.
- 6.
Strictly speaking there are two types of rulemakings: Formal and informal. Federal agencies in the modern era hardly ever follow formal rulemaking procedures. Because, for example, they involving hearings and the introduction of testimony under very strict procedures, formal rulemakings are incredibly easy to delay by affected industry actors and highly inefficient. Agencies instead prefer to use the “informal” rulemaking procedures briefly described here.
- 7.
Pre-amendment devices or other existing, lawfully marketed medical devices to which the new device will be compared are referred to as “predicate devices” or, simply, “predicates.”
- 8.
E.g., “How to find and effectively use predicate devices,” https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm134571.htm, last accessed September 8, 2018. Fortunately FDA is not graded on grammar.
- 9.
Significant changes in materials, design, energy sources or other physical traits.
- 10.
E.g., the “Smart Dongle Blood Glucose Monitoring System,” which includes a blood glucose meter, test strips and a mobile platform (in this case the iPhones 4 through 6s Plus) for calculating and displaying results. See https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162382.pdf (last accessed September 9, 2018).
- 11.
21 CFR § 880.6230.
- 12.
21 CFR § 862.2120.
- 13.
Cite.
- 14.
21 CFR § 870.1130.
- 15.
See “Global Approach to Software as a Medical Device” at https://www.fda.gov/MedicalDevices/DigitalHealth/SoftwareasaMedicalDevice/ucm587925.htm (last accessed September 9, 2018).
- 16.
The failsafe mechanism for situations presenting a disjunction between a product’s legally mandated classification of a product and its actual degree of risk is the “De Novo” 510k. See below.
- 17.
Limited cases of other, legitimate uses for IDEs exist but aren’t immediately relevant here, e.g., “compassionate use.”
- 18.
Again, clinical testing will be the primary cost driver.
- 19.
These products are being used only as examples of digital health products recent cleared under de novo 510ks—no endorsement is made or implied and the authors have no affiliations with the companies.
- 20.
The “MATRx plus” produced by Zephyr Sleep Technologies, Inc. (Calgary, Alberta (Canada)). The company “designs, develops and manufactures medical devices for the diagnosis and treatment of sleep-disordered breathing,” https://www.zephyrsleep.com/company/about-us/.
- 21.
The “IDx-DR” produced by IDx, LLC (Coralville, IA). The company describes itself as “focused on developing clinically-aligned autonomous algorithms that detect disease in medical images,” https://www.eyediagnosis.net/.
- 22.
- 23.
This product is being used only as an example of a digital health product approved through the PMA process—no endorsement is made or implied and the authors have no affiliations with the company. PowerLook® Tomo Detection Software is a product of ICAD Inc. of Nashua, N.H.
- 24.
See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160009, last accessed September 8, 2018, for basic information and links to FDA’s summary of approval.
- 25.
FDA did not refer the product to an advisory panel (for radiological devices) because the panel had already reviewed duplicate information.
- 26.
See n. 22, above.
- 27.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.pdf (last accessed September 9, 2018).
- 28.
See n.25, e.g., “[a] scientific or medical journal article that includes information on unapproved uses and is distributed by manufacturers should first have been published by an organization that has an editorial board that uses experts who have demonstrated expertise in the subject of the article under review by the organization. Experts should be independent of the organization and should review and objectively select, reject, or provide comments about proposed articles.”
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Sapsin, J. (2020). FDA and Digital Health. In: Wulfovich, S., Meyers, A. (eds) Digital Health Entrepreneurship. Health Informatics. Springer, Cham. https://doi.org/10.1007/978-3-030-12719-0_10
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