From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 16
In 2004, the Center for Devices and Radiological Health of the US Food and Drug
Administration (FDA) unexpectedly and surprisingly cleared a 510(k) submission for
medical maggots (K033391). In the clearance letter, the agency determined that the device
was substantially equivalent to legally marketed predicate devices marketed in interstate
commerce prior to 28 May 1976 or to devices that have been reclassified in accordance
with the provisions of the Food, Drug, and Cosmetic Act (FD&C Act). As the device is
unclassified, the company must comply with general controls provisions of the act to pro-
vide reasonable assurance of safety and effectiveness. Thus, maggots became the first live
animals to gain approval as a medical device.
The second surprise occurred six months later, when FDA announced in a Talk
Paper that for the first time it had cleared leeches for medicinal purposes.1 In that same
document, the agency stated that it had reviewed the published literature and evaluated
safety data submitted by the firm. According to FDA, leeches are medical devices because
they meet the definition of such under the FD&C Act. To meet the definition of a medical
device, leeches must not achieve their primary effect through a chemical action and must
not be metabolized. The same requirements also apply to medical maggots. This charac-
terization brings up an interesting situation and harkens back to the early days of food
and drug law, when medical devices were first included in the statute. A review of the his-
tory is in order, along with a brief discussion of the mechanisms of action of these newly
dubbed “devices.”
History
In reintroducing the bill that would eventually become the FD&C Act of 1938, its spon-
sor, Senator Royal Copeland of New York, 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 this definition permitted
escape from legal control of all therapeutic or curative devices like electric belts. During
the Senate debate that followed, Senator Bennett Champ Clark of Missouri contended that
it was improper, as a matter of common language, to classify medical devices as drugs.2
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 debate over what constitutes a device, a separate definition
was added to the final legislation.3 Today, a medical device is defined as follows in Section
201 (h) of the FD&C Act:
“…an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including any component, part, or acces-
sory, which is 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.” (Emphasis added.)
The original definition of a medical device included in the 1938 legislation made no refer-
ence to intended purposes through chemical action or to metabolism. The word “article”
was not used neither was there a reference to implants, in vitro reagents, implements or
machines.
The term “drug” in Section 201(g)(1) of the act is defined to mean, among other
things, “articles intended for use in the diagnosis, cure, mitigation, treatment or pre-
vention of disease and articles (other than food) intended to affect the structure or any
function of the body of man or other animals.” The term “articles,” which appears in the
In 2004, the Center for Devices and Radiological Health of the US Food and Drug
Administration (FDA) unexpectedly and surprisingly cleared a 510(k) submission for
medical maggots (K033391). In the clearance letter, the agency determined that the device
was substantially equivalent to legally marketed predicate devices marketed in interstate
commerce prior to 28 May 1976 or to devices that have been reclassified in accordance
with the provisions of the Food, Drug, and Cosmetic Act (FD&C Act). As the device is
unclassified, the company must comply with general controls provisions of the act to pro-
vide reasonable assurance of safety and effectiveness. Thus, maggots became the first live
animals to gain approval as a medical device.
The second surprise occurred six months later, when FDA announced in a Talk
Paper that for the first time it had cleared leeches for medicinal purposes.1 In that same
document, the agency stated that it had reviewed the published literature and evaluated
safety data submitted by the firm. According to FDA, leeches are medical devices because
they meet the definition of such under the FD&C Act. To meet the definition of a medical
device, leeches must not achieve their primary effect through a chemical action and must
not be metabolized. The same requirements also apply to medical maggots. This charac-
terization brings up an interesting situation and harkens back to the early days of food
and drug law, when medical devices were first included in the statute. A review of the his-
tory is in order, along with a brief discussion of the mechanisms of action of these newly
dubbed “devices.”
History
In reintroducing the bill that would eventually become the FD&C Act of 1938, its spon-
sor, Senator Royal Copeland of New York, 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 this definition permitted
escape from legal control of all therapeutic or curative devices like electric belts. During
the Senate debate that followed, Senator Bennett Champ Clark of Missouri contended that
it was improper, as a matter of common language, to classify medical devices as drugs.2
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 debate over what constitutes a device, a separate definition
was added to the final legislation.3 Today, a medical device is defined as follows in Section
201 (h) of the FD&C Act:
“…an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including any component, part, or acces-
sory, which is 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.” (Emphasis added.)
The original definition of a medical device included in the 1938 legislation made no refer-
ence to intended purposes through chemical action or to metabolism. The word “article”
was not used neither was there a reference to implants, in vitro reagents, implements or
machines.
The term “drug” in Section 201(g)(1) of the act is defined to mean, among other
things, “articles intended for use in the diagnosis, cure, mitigation, treatment or pre-
vention of disease and articles (other than food) intended to affect the structure or any
function of the body of man or other animals.” The term “articles,” which appears in the