Were sales of a disposable directional coronary atherectomy system to Florida hospitals exempt from sales tax?

Subject

Directional Coronary Atherectomy System

Plain-English summary

Sales of the directional coronary atherectomy system to hospitals were exempt from Florida sales tax. The disposable device was a hollow tube introduced into coronary arteries to cut and retrieve plaque, and its FDA materials identified it as a coronary atherectomy catheter.

Florida's cited rule specifically listed catheters as exempt prosthetic and orthopedic appliances.

What this means for you

The ruling turned on the product's documented classification as a catheter. A device with a different design, function, or regulatory description would require its own analysis.

Common questions

Was the system reusable? No. It was intended for one-time use.

Why was it exempt? Catheters were specifically listed as exempt under the cited rule.

Did the ruling cover sales to hospitals? Yes.

Citations and references

• Fla. Stat. §§ 212.08(2)(a) and 213.22
• Fla. Admin. Code r. 12A-1.021(1)(a)-(b)

Source

• Landing page: Florida Tax Law Library
• Advisement: TAA 94A-037

Original ruling text

Jun 21, 1994

Re: TAA 94A-037
Directional Coronary Atherectomy System
Section 212.08(2)(a), F.S.
Rule 12A-1.021(1)(a) and (b), F.A.C.

Dear :

This is in response to your letter of May 9, 1994, in which
you requested the issuance of a technical assistance advisement
regarding the taxability of your company's sale of the
Directional Coronary Atherectomy System to hospitals. You
enclosed information regarding the device which included a
summary of Safety and Efficacy which your company filed with the
U.S. Food and Drug Administration when seeking approval for
commercial distribution of the device. The summary stated that
the generic name of the device is "Coronary Atherectomy
Catheter" and its trade name is "Simpson Coronary AtheroCath."
The device is a hollow tube that is introduced into a patient's
arteries for purposes of excising and retrieving plaque from the
patient's diseased coronary arteries. It is intended for one
time use and is disposable.

APPLICABLE AUTHORITY

Section 212.08(2)(a), F.S., provides in part:

"(2) EXEMPTIONS; MEDICAL."(a) There shall be exempt from the tax imposed by this
chapter any product, supply, or medicine dispensed in a
retail establishment by a pharmacist licensed by the state,
according to an individual prescription or prescriptions
written by a prescriber authorized by law to prescribe
medicinal drugs; hypodermic needles; hypodermic syringes;
chemical compounds and test kits used for the diagnosis or
treatment of human disease, illness, or injury; and common
household remedies recommended and generally sold for

internal or external use in the cure, mitigation,
treatment, or prevention of illness or disease in human
beings, but not including cosmetics or toilet articles,
notwithstanding the presence of medicinal ingredients
therein, according to a list prescribed and approved by the
Department of Health and Rehabilitative Services, which
list shall be certified to the Department of Revenue from
time to time and included in the rules promulgated by the
Department of Revenue. There shall also be exempt from the
tax imposed by this chapter artificial eyes and limbs;
orthopedic shoes; prescription eyeglasses and items
incidental thereto or which become a part thereof;
dentures; hearing aids; crutches; prosthetic and orthopedic
appliances; and funerals...." (emphasis supplied)
Rule 12A-1.021(1)(a) and (b), F.A.C., provides in part:

"(1)(a) Prosthetic and orthopedic appliances are exempt.
The term `prosthetic and orthopedic appliances' means any
apparatus, instrument, device, or equipment used to replace
or substitute for any missing part of the body, used to
alleviate the malfunction of any part of the body, or used
to assist any disabled person in leading a normal life by
facilitating such person's mobility. Such apparatus,
instrument, device, or equipment shall be exempted
according to an individual prescription or prescriptions
written by a duly licensed practitioner authorized by the
laws of the state to prescribe medicinal drugs, or
according to a list prescribed and approved by the
Department of Health and Rehabilitative Services, which
list shall be certified to the Department from time to
time. A list of prosthetic and orthopedic appliances (DR46NT), Nontaxable Medical and General Grocery List, dated
October, 1987, which is incorporated in this rule and made
part of this rule by reference, which has been certified to
the Department of Revenue by the Department of Health and
Rehabilitative Services, is available without cost, upon
written request directed to the Department of Revenue,
Supply Section, Tallahassee, Florida 32399-0100.
"(b) The prosthetic and orthopedic appliances listed below
are specifically exempt:...
"Catheters...."

DEPARTMENT RESPONSE

Section 212.08(2)(a), F.S., provides an exemption from tax
for the sale of prosthetic and orthopedic appliances. Rule 12A1.021(1)(b), F.A.C., states that the products listed therein are
specifically exempt from tax. Catheters are included in this
list. Based on the information you furnished this office,
contained in the Summary of Safety and Efficacy which your
company filed with the U.S. Food and Drug Administration, the
device in question is a catheter. Therefore, your company's
sale of the Directional Coronary Atherectomy System to hospitals
is exempt from tax as a sale of a catheter under section
212.08(2)(a), F.S., and Rule 12A-1.021(1)(b), F.A.C.

This response constitutes a Technical Assistance Advisement
under s. 213.22, F.S., which is binding on the department only
under the facts and circumstances described in the request for
this advice as specified in s. 213.22, F.S. Our response is
predicated on those facts and the specific situation summarized
above. You are advised that subsequent statutory or
administrative rule changes or judicial interpretations of the
statutes or rules upon which this advice is based may subject
similar future transactions to a different treatment than
expressed in this response.

You are further advised that this response and your request
are public records under Chapter 119, F.S., which are subject to
disclosure to the public under the conditions of s. 213.22, F.S.
Your name, address, and any other details which might lead to
identification of the taxpayer must be deleted by the Department
before disclosure. In an effort to protect the confidentiality
of such information, we request you notify the undersigned in
writing within 15 days of any deletions you wish made to the
request or the response.

Sincerely,

Richard S. Harrod
Technical Assistant

RSH/h
Control No. 15693