Are sales of an Rx-only, single-use surgical device to Florida hospitals and surgical centers exempt when it is prescribed for one patient and permanently implanted?

Plain-English summary

The seller's Rx-only, single-use surgical device was exempt from Florida sales and use tax when sold to hospitals and surgical centers for permanent implantation in a specifically prescribed patient. The device's label established its medical purpose, and each unit was assigned to one patient, was not reusable or transferable, and was permanently incorporated into that patient during surgery.

The taxpayer argued that the device also fit the prosthetic-appliance exemption. The Department's conclusion instead relied on the broader prescription medical-product rules in section 212.08(2)(a) and Rule 12A-1.020(6): qualifying products sold to healthcare entities can be exempt when they are prescription-only, intended for one patient, not reusable, or temporarily or permanently incorporated into a patient by a licensed practitioner.

What this means for you

Medical-device manufacturers and sellers

Keep the product label, federal or state prescription restriction, patient-specific order, single-use documentation, and implantation instructions together. The TAA tied the exemption to that complete fact pattern.

Hospitals and surgical centers

The ruling did not exempt every device purchased by a facility. It addressed a specific device prescribed for one patient and permanently implanted by a licensed practitioner.

Accountants and tax professionals

Analyze the medical-product exemption before assuming a product must meet the separate prosthetic-appliance definition. Also confirm documentation and whether the device is reusable facility equipment.

Common questions

Q: Was the surgical device exempt?
A: Yes, under the specific Rx-only, single-use, patient-specific, permanently implanted facts.

Q: Did the hospital's status alone make the purchase exempt? A: No. The Department relied on the product label, prescription, single-patient use, and implantation facts.

Q: Did Florida rule that the device was a prosthetic appliance? A: The taxpayer made that argument, but the Department's stated conclusion relied on the prescription medical-product and incorporation rules instead.

Q: Would a reusable device receive the same treatment?
A: This TAA does not say so. The described device was expressly labeled Single Use and permanently implanted.

Citations and references

• Fla. Stat. § 212.02(19)
• Fla. Stat. §§ 212.05, 212.055, and 212.08(2)(a)
• Fla. Admin. Code r. 12A-1.020(6)(a), (c)1., and (d)1.
• Fla. Stat. § 213.22; Fla. Admin. Code ch. 12-11
• Wanda Marine Corp. v. Department of Revenue, 305 So. 2d 65, 69 (Fla. 1st DCA 1975)

Source

• Landing page: Florida Tax Law Library
• Advisement: TAA 26A-008

Original ruling text

EPARTMENT OF REVENUE

Florida Department of Revenue Jim Zingale
Office of Technical Assistance Executive Director
a
5050 West Tennessee Street Tallahassee FL 32399 floridarevenue.com

QUESTION: Taxpayer seeks confirmation that its sales of Device to hospitals and surgical centers are not subject to tax when Device is prescribed for a specific patient and permanently implanted as part of a surgical procedure.

ANSWER: Since Device is labeled Rx Only and Single Use and is permanently implanted into a patient, Taxpayer’s sales of Device to hospitals and surgical centers are exempt from Florida sales and use tax.

April 6, 2026

Vie oni

Re:

Technical Assistance Advisement — TAA #: 26A-008

“Taxpayer”
Sales and Use Tax —
Sections 212.02, 212.05, and 212.08, Florida Statutes - (“F.S.”)

Rule 12A-1.020, Florida Administrative Code - (“F.A.C.”)
BP #:

This is in response to your letter dated, a. requesting this Department’s issuance of a Technical Assistance Advisement (“TAA”) pursuant to Section(s.) 213.22, F.S., and Rule Chapter 12-11 F.A.C, Florida Administrative Code, regarding the matter discussed below. Your request has been carefully examined, and the Department finds it to be in compliance with the requisite criteria set forth in Chapter 12-11, F.A.C. This response to your request constitutes a TAA and is issued to you under the authority of s. 213.22, F.S.

Requested Advisement

Taxpayer seeks confirmation that its sales of a surgical device called the

(also referred to as a in FDA terminology), hereinafter referred to as “Device” to hospitals and surgical centers are not subject to tax when Device is prescribed for a specific patient and permanently implanted as part of a surgical procedure.

Technical Assistance Advisement
April 6, 2026

Facts

Taxpayer is

Device is a sterile, implantable surgical device designed specifically for Device plays a critical role in surgical procedures, allowing for
. Device is classified as an FDA Class II medical device.

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Device is

Taxpayer sells Device exclusively to hospitals and surgical centers, ensuring that each transaction complies with state and federal medical device regulations. Sales of Device occur under the direct supervision of licensed medical professionals, reinforcing the product’s role as a regulated surgical implant intended for medical use only. Each purchase of Device requires a physician’s prescription and is designated for a specific patient’s surgical procedure. Device is permanently implanted in the patient, ensuring that it is not reusable, transferrable, or available for over-the-counter sale. Additionally, for tax classification purposes, Device is considered to be tangible personal property. In an email, Taxpayer provided a copy of a label that is attached to Device. The label indicates the following pertinent information: “Rx Only: and Single Use.”

Taxpayer Position

Florida law provides specific exemptions from sales and use tax for medical products under
§212.08(2)(b)(1), F.S., which exempts prosthetic and orthopedic appliances that replace or substitute for a missing or malfunctioning body part and are dispensed according to a prescription by a licensed physician. Section 212.08(2)(b)(1), F.S., defines prosthetic and orthopedic appliances to mean “any apparatus, instrument, device, or equipment used to replace or substitute for any missing part of the body, to alleviate the malfunction of any part of the body, or to assist any disabled person in leading a normal life by facilitating such person’s mobility.” Additionally, Rule 12A-1.020(6)(a), F.A.C., defines medical products, supplies, or devices as “any product, supplies, or devices that are intended or designed to be used for a medical purpose to treat, prevent, or diagnose human disease, illness, or injury”. Section (c) further provides that these medical products are exempt when dispensed according to a physician’s prescription. Further precedent supporting this interpretation includes Florida TAA 92A-044, which confirmed that permanently implanted medical devices qualify as exempt prosthetic appliances, and Florida TAA 11A-008,

Technical Assistance Advisement
April 6, 2026
Page 3

which ruled that sales of prescription-based medical devices to hospitals for implantation are tax exempt. Additionally, Florida TAA 02A-042 establishes that all medical products sold or dispensed pursuant to a physician’s prescription are exempt from tax. Applying these laws to Device, Taxpayer asserts that Device meets the statutory definition of a prosthetic appliance under
§212.08(2), F.S. The device is implanted in the patient during surgery, aligning with the exemption criteria established by Rule 12A-1.020(6), F.A.C. Furthermore, because each sale requires a prescription or physician’s order for a specific patient, it satisfies the requirement that tax-exempt medical appliances must be dispensed under a licensed physician’s directive. Given these factors, Taxpayer believes Device qualifies for exemption under Florida sales and use tax law.

Law and Discussion

Unless a specific exemption applies, s. 212.05, F.S., provides it is the legislative intent that every person is exercising a taxable privilege that engages in the business of selling tangible personal property! in this state. For exercising such a privilege, a tax is levied on each taxable transaction or incident. The tax is due and payable at the rate of 6 percent, plus any applicable surtaxes imposed under s. 212.055, F.S., on the total consideration received for each item or article of tangible personal property when sold at retail in this state. Exemptions from tax are strictly construed against the claimant. Wanda Marine Corp. v. Dep't of Revenue, 305 So. 2d 65, 69 (Fla. 1st DCA 1975).

Section 212.08(2)(a), F.S., provides that certain medical products and supplies” are specifically exempt from tax when dispensed according to an individual prescription written by a prescriber authorized by law. Additionally, items are exempt if included on the Nontaxable Medical Items and General Grocery List, form DR-46NT, as approved by the Department of Business and Professional Regulation.

Pursuant to Rule 12A-1.020(6)(c)1., F.A.C., medical products, supplies, or devices sold to hospitals and healthcare entities or to licensed practitioners are exempt when dispensed under federal or state law only by the prescription or order of a licensed practitioner and are intended for use on a single patient and not intended to be reusable.

Medical products, supplies, or devices used in the cure, mitigation, alleviation, prevention, or treatment of injury, disease, or incapacity of a patient(s) that are temporarily or permanently incorporated into a patient(s) by a licensed practitioner are specifically exempt (See Rule 12A- 1.020(6)(d)1., F.A.C.).

' Tangible personal property means and includes personal property which may be seen, weighed, measured, or touched or is in any manner perceptible to the senses. See s. 212.02(19), F.S.

2 “Medical products, supplies, or devices” are “any products, supplies, or devices that are intended or designed to be used for a medical purpose to treat, prevent, or diagnose human disease, illness, or injury. The purpose is assigned to a product, supply, or device by its label or its general instructions for use.” See Rule 12A-1.020(6)(a), F.A.C.

Technical Assistance Advisement
April 6, 2026
Page 4

As provided in Rule 12A-1.020(6)(a), F.A.C., a medical product’s label provides the medical product’s purpose. Taxpayer’s sales of Device, which carry “RX” and “Single Use” labels and which are permanently implanted as part of a surgical procedure would be exempt from Florida sales tax under s. 212.08(2)(a), F.S. and Rule 12A-1.020, F.A.C., as discussed above.

Conclusion

Since Device is labeled Rx Only and Single Use and is permanently implanted into a patient, Taxpayer’s sales of Device to hospitals and surgical centers are exempt from Florida sales and use tax.

This response constitutes a TAA 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, your request and related backup documents are public records under Chapter 119, F.S., and are subject to disclosure to the public under the conditions of s. 213.22, F.S. Confidential information must be deleted before public disclosure. In an effort to protect confidentiality, we request you provide the undersigned with an edited copy of your request for TAA, the backup material and this response, deleting names, addresses and any other details which might lead to identification of the Taxpayer. Your response should be received by the Department within ten (10) days of the date of this letter.

If you have any further questions with regard to this matter and wish to discuss them, you may contact me directly at (850)717-6363.

Sincerely,

Leigh €. Ceci
Leigh L. Ceci, MAcc
Tax Law Specialist

Office of Technical Assistance (850)717-6363

Gk Gz

Record ID: 7001440675

Technical Assistance Advisement
April 6, 2026
Page 5

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