Transitional device definition

Transitional device means a device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976.
Transitional device means a device subject to section 520(1) of the FD&C Act and which the FDA previously regulated as a new drug or an antibiotic drug before May 28, 1976.
Transitional device means a device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976. Food and Drug Administration, HHS § 812.18

Examples of Transitional device in a sentence

  • Transitional device – a product defined as a device as of May 28, 1976, but previously considered by FDA to be a new drug or an antibiotic drug (21 CFR 812.3(r)).

  • Transitional device – a device subject to 21 U.S.C. § 360j(1) of the act, that is, a device that the FDA considered to be a new drug or an antibiotic drug before May 28, 1976.

  • Transitional device means a device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976.

  • MOVED (TURNER), SECONDED (STOMBERG) AND PASSED UNANIMOUSLY TO ADOPT THE FOLLOWING RESOLUTION: RESOLVED, THAT THE BOARD OF SELECTMEN REFERS TO THE BOARD OF FINANCE ITS RECOMMENDATION THAT THE TOWN AUTHORIZE THE ISSUE OF $6,736,250 BONDS OR NOTES AND TEMPORARY NOTES TO FINANCE THE APPROPRIATION, THE AMOUNT OF BONDS OR NOTES AUTHORIZED TO BE REDUCED BY THE AMOUNT OF GRANTS OR OTHER FUNDS RECEIVED FOR THE PROJECT AND NOT SEPARATELY APPROPRIATED TO PAY ADDITIONAL COSTS OF THE PROJECT.

  • Transitional device: A device that was regulated by FDA as a new drug before May 28, 1976 before FDA classification systems were changed.


More Definitions of Transitional device

Transitional device means a device that the FDA considered to be a new drug or an antibiotic drug before May 28, 1976 (21 CFR Sec. 812.3(r)). 4

Related to Transitional device

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • Transitional Services means services involving technical or specialized knowledge required to complete a project or to provide temporary consulting services to the City.

  • Professional development means training programs for

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • National Medical Support Notice or “NMSN” shall mean a notice that contains the following information:

  • Transitional housing means buildings configured as rental housing developments, but operated under program requirements that require the termination of assistance and recirculating of the assisted unit to another eligible program recipient at a predetermined future point in time that shall be no less than six months from the beginning of the assistance.

  • Control device means equipment (such as an incinerator or carbon adsorber) used to reduce, by destruction or removal, the amount of air contaminants in an air stream prior to discharge to the ambient air.

  • Assistive technology device means any item, piece of equipment, or product system that is used to increase, maintain, or improve the functional capacities of a child with a disability.

  • continuing professional development means the continuing professional development contemplated in section 32;

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Transition means: 1) the formal and physical process of transferring from school to school or 2) the period of time in which a student moves from one school in the sending state to another school in the receiving state.

  • Cephalometric device means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

  • Transitional Services Agreement means that certain Transitional Services Agreement to be entered into at the Closing between Seller or any of its Affiliates on the one hand, and Purchaser, on the other hand, in the form of Exhibit 10.1.236.

  • Traffic control device means a flagger, sign, signal, marking, or other device used to regulate, warn or guide traffic, placed on, over, or adjacent to a street, highway, private road open to public travel, pedestrian facility, or shared-use path by authority of a public agency or official having jurisdiction, or, in the case of a private road open to public travel, by authority of the private owner or private official having jurisdiction.

  • Consumables and medical devices means (consumables) items that require regular replacement (e.g. batteries) to keep a medical device (such as a hearing aid) operational. Many medical devices require consumables.

  • Assistive technology service means any service that directly assists a child with a disability in the selection, acquisition, or use of an assistive technology device. The term includes:

  • Technology Transfer Agreement has the meaning given in Section 2.2(e).

  • Marketing Agreement means an agreement entered into, with the director, by producers, distributors, processors, or handlers pursuant to this act and binding only on those signing the agreement.

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • Local Marketing Agreement means, a local marketing agreement, time brokerage agreement or similar arrangement pursuant to which a Person, subject to customary licensee preemption rights and other limitations, obtains the right to exhibit programming and sell advertising time constituting 15% or more of the air time per week of a television broadcast station licensed to another Person.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Licensed health care provider means a physician, physician assistant, chiropractor, advanced registered nurse practitioner, nurse, physical therapist, or athletic trainer licensed by a board.