From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 56
In a previous article, I commented on the astonishing medical device classification and
subsequent 510(k) clearances for maggots and leeches.1 Surprises continue to occur as
the US Food and Drug Administration (FDA) now has recognized honey as a medical
device with a legitimate medical use. API-MED, an absorbent dressing containing active
manuka honey, was recently cleared and indicated for treating exuding wounds such
as diabetic foot and leg ulcers and first- and second-degree partial thickness burns. The
labeling makes no mention about antimicrobial effects, although other countries (Canada,
Australia, Great Britain and New Zealand) permit that claim.2
Honey, maggots and leeches, by their very nature, challenge the regulatory scheme.
Assigning each to the broad category of devices was an expedient solution to a conun-
drum. As drugs, they would have required studies entailing an interminable regulatory
process. The agency’s decision-making process is rooted in the first inclusion of medi-
cal devices in the statute. An historical review once again helps understand how the
agency interprets the law. However, it is not clear how or why the agency employs the
device classification as a default category in the approval process. All that aside, it is
indeed fortunate that FDA can be liberal in granting marketing approval under special
circumstances.
History
In re-introducing the bill that would eventually become the Federal Food, Drug, and
Cosmetic Act of 1938 (FD&C Act), Senator Royal Copeland, its sponsor, explained that
the existing law (the Pure Food and Drug Act) defined drugs as substances or mixtures
of substances intended to be used for the cure, mitigation or prevention of disease. He
noted that the definition permitted escape from legal control of all therapeutic or cura-
tive devices like electric belts. During the debate that followed, Senator Bennett Clark of
Missouri contended that it was improper, as a matter of common language, to classify
medical devices as drugs.3 He went on to say that calling a medical device a drug was
like “calling a sheep’s tail a leg.” Because of the continued criticism of what constitutes a
device, a separate definition was added to the final legislation.4 Today, a medical device
is defined as an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent or other similar or related article including any component, part or acces-
sory, recognized in the official National Formulary, or the United States Pharmacopoeia, or
any supplement to them, 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, and
which does not achieve its primary intended purposes through chemical action within or
on the body of man of other animals and which is not dependent upon being metabolized
for the achievement of its primary intended purposes. The original definition of a medical
device included in the FD&C Act made no reference to intended purposes through chemi-
cal action or to metabolism.5 The word “article” was not used, and there was no reference
to implants, in vitro reagents, implements or machines.
The term “drug” is defined, among other things, as “articles intended for use in the
diagnosis, cure, mitigation, treatment or prevention of disease” and “articles” (other than
food) intended to affect the structure or any function of the body of man or other animals.6
The term “articles” appearing in the drug definition is a broad category, in contrast to the
list of specific product types that are “devices.” Except for implants and in vitro reagents,
most items included in the definition of a device are mechanical products, generally con-
structed of solid materials like metal or plastic. Under the definition of medical devices,
FDA may not regulate as a medical device an article that achieves any of its principal
intended medical purposes through chemical action or by being metabolized. Congress
did not insert any counterpart clause into the definition of a “drug” that would make
chemical or metabolic action a prerequisite to a product being regulated as such. Neither
In a previous article, I commented on the astonishing medical device classification and
subsequent 510(k) clearances for maggots and leeches.1 Surprises continue to occur as
the US Food and Drug Administration (FDA) now has recognized honey as a medical
device with a legitimate medical use. API-MED, an absorbent dressing containing active
manuka honey, was recently cleared and indicated for treating exuding wounds such
as diabetic foot and leg ulcers and first- and second-degree partial thickness burns. The
labeling makes no mention about antimicrobial effects, although other countries (Canada,
Australia, Great Britain and New Zealand) permit that claim.2
Honey, maggots and leeches, by their very nature, challenge the regulatory scheme.
Assigning each to the broad category of devices was an expedient solution to a conun-
drum. As drugs, they would have required studies entailing an interminable regulatory
process. The agency’s decision-making process is rooted in the first inclusion of medi-
cal devices in the statute. An historical review once again helps understand how the
agency interprets the law. However, it is not clear how or why the agency employs the
device classification as a default category in the approval process. All that aside, it is
indeed fortunate that FDA can be liberal in granting marketing approval under special
circumstances.
History
In re-introducing the bill that would eventually become the Federal Food, Drug, and
Cosmetic Act of 1938 (FD&C Act), Senator Royal Copeland, its sponsor, explained that
the existing law (the Pure Food and Drug Act) defined drugs as substances or mixtures
of substances intended to be used for the cure, mitigation or prevention of disease. He
noted that the definition permitted escape from legal control of all therapeutic or cura-
tive devices like electric belts. During the debate that followed, Senator Bennett Clark of
Missouri contended that it was improper, as a matter of common language, to classify
medical devices as drugs.3 He went on to say that calling a medical device a drug was
like “calling a sheep’s tail a leg.” Because of the continued criticism of what constitutes a
device, a separate definition was added to the final legislation.4 Today, a medical device
is defined as an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent or other similar or related article including any component, part or acces-
sory, recognized in the official National Formulary, or the United States Pharmacopoeia, or
any supplement to them, 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, and
which does not achieve its primary intended purposes through chemical action within or
on the body of man of other animals and which is not dependent upon being metabolized
for the achievement of its primary intended purposes. The original definition of a medical
device included in the FD&C Act made no reference to intended purposes through chemi-
cal action or to metabolism.5 The word “article” was not used, and there was no reference
to implants, in vitro reagents, implements or machines.
The term “drug” is defined, among other things, as “articles intended for use in the
diagnosis, cure, mitigation, treatment or prevention of disease” and “articles” (other than
food) intended to affect the structure or any function of the body of man or other animals.6
The term “articles” appearing in the drug definition is a broad category, in contrast to the
list of specific product types that are “devices.” Except for implants and in vitro reagents,
most items included in the definition of a device are mechanical products, generally con-
structed of solid materials like metal or plastic. Under the definition of medical devices,
FDA may not regulate as a medical device an article that achieves any of its principal
intended medical purposes through chemical action or by being metabolized. Congress
did not insert any counterpart clause into the definition of a “drug” that would make
chemical or metabolic action a prerequisite to a product being regulated as such. Neither