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Pennsylvania Code (Rules and Regulations)
Title 28 - HEALTH AND SAFETYPart III - Prevention of DiseasesChapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICSSubchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
GENERAL PROVISIONS
Section 25.1 - Definitions

28 Pa. Code § 25.1

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Current through Register Vol. 54, No. 45, November 9, 2024
Section 25.1 - Definitions

The following words and terms when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

Act-The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101-780-144).

Department-The Department of Health of the Commonwealth.

Device-Includes the following:

(i) An instrument, apparatus or contrivance, including their components, parts and accessories, intended as follows:
(A) For use in the diagnosis, cure, mitigation, treatment or prevention of disease of man or other animals.
(B) To affect the structure or a function of the body of man or other animals.
(ii) The term device shall include the following:
(A) Artificial eyes.
(B) Artificial limbs.
(C) Bandages and dressings, including, but not limited to, adhesive bandages, sterile gauze and cotton products, and elastic bandages and braces.
(D) Birth control devices, including, but not limited to, intrauterine devices, prophylactics, and vaginal diaphragms.
(E) Blood pressure testing apparatus.
(F) Body braces and supports, including, but not limited to, crutches, walkers and orthopedic braces and supports.
(G) Cardiac pacemakers and accessories.
(H) Colostomy and ileostomy appliances, bags and supplies.
(I) Corn pads or plasters.
(J) Dental materials which are transferred to the patient, including, but not limited to, dentures, fillings, crowns, inlays, bridges, and apparatus.
(K) Dialysis machines and artificial kidneys.
(L) Electronic therapeutic or diagnostic products.
(M) Eyeglasses and hard contact lenses.
(N) Hearing aids.
(O) Inhalation therapy equipment and emergency breathing equipment, including but not limited to atomizers, intermittent positive pressure breathing units, iron lungs, vaporizers, and oxygen equipment.
(P) Lamps, ultra-violet or infra-red.
(Q) Needles.
(R) Syringes.
(S) Physical therapy equipment for professional or home use, including but not limited to diathermy machines, electronic muscle stimulators, traction units, therapeutic vibrators, and whirlpool units.
(T) Surgical implants.
(U) Sutures.
(V) Thermometers.
(W) Urine test kits sold over-the-counter for home use.
(X) Wheelchairs.

Secretary-The Secretary of Health of the Commonwealth.

28 Pa. Code § 25.1

The provisions of this §25.1 amended April 8, 1977, 7 Pa.B. 997.

The provisions of this §25.1 issued under section 2102 of The Administrative Code of 1929 (71 P. S. § 532); and sections 6 and 35 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-106 and 780-135).