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