The question that comes up in almost any deep and detailed discussion related to the emerging mHealth market is: how does or will medical device regulation apply? Sometimes it surprises people, especially outside of the industry, that this is even a consideration. Is a Doctor’s Blackberry really a “medical device”? The answer is a resounding: maybe.
The FDA in the United States is the primary focus of most of the relevant information and speculation and to date there has been very little consolidation of facts available to healthcare executives and the vendor market to review.
To fill this gap MobiHealthNews one of, if not the leading online site covering the mHealth market has published a free report entitled “FDA Regulation of Mobile Health” which covers a great deal of this ground. The report is written by Bradley Merrill Thompson who leads the Medical Device Regulatory Practice, the Clinical Trials Practice and the Connected Health Practice for law firm of Epstein Becker Green, P.C. and who clearly knows a thing or two about the subject.
What is a “Medical Device” then?
The report begins with a few definitions that provide context for further discussions as well as a little overall clarity. The definition used for a “medical device” is the FDA’s own, coming from Section 201(h) of the Federal Food, Drug, and Cosmetic Act:
… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or] intended to affect the structure or any function of the body of man or other animals.
Components and Accessories
The two other distinctions the report points out are that of a “component” and an “accessory”. Both are regulated but to different extents and as a vendor, understanding this distinction is the key to minimizing or managing the level of compliance required.
Interestingly, the difference is defined not so much by the actual equipment or technology, but rather by who is purchasing it. End users buy “accessories” while manufactures buy “components” even though for all intents in purposes the actual device may be identical this distinction governs the regulatory compliance that will need to be met.
Summary
For those with an interest in the topic the report is extremely accessible even though it covers very technical and legal subject matter. For vendors or manufactures developing products in the mHealth market, the report is a must read if nothing else to ensure that your understanding of regulatory compliance is in line with the FDAs.
Resources:
Download of read the report online at here,
And find more mHealth news and reports at MobiHealthNews
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