FDA Product definition

FDA Product shall have the meaning ascribed to such term in Section 3.1(nn).
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FDA Product means any product in current commercial distribution in the United States as an FDA regulated medical device that is either a Class I or Class II medical device, as defined under 21 U.S.C. §360c and the applicable rules and regulations thereunder, or is exempt from such premarket notification in accordance with 21 U.S.C. §360(l) or (m) and the applicable rules and regulations thereunder.
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FDA Product means a Product that is approved by the FDA or any other Regulatory Authorities.
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Examples of FDA Product in a sentence

  • For full product code details visit the FDA Product Code Builder.

  • For FDA filings, the Product Code Qualifier is always “FDP”.Only one FDA Product Code Number is allowed per line.

  • FDA Product Regulation 28 FDA Approved Oncology NGS Tests 33 Regulation 33 Technical Specifications 39 Performance Specifications 43 Oncomine Dx Target Test 43 MSK-IMPACT Test 47 FoundationOne CDx Test 49 Operational Considerations 52 Operational Specifications 52 Test Workflows 54 Clinical Report.

  • Record Identifier PG02 (Product Identifier)Data ElementLength/ Class Only one FDA Product Code Number per line is allowed.

  • The use of the designations "Product May Proceed," "Product Released by FDA," "Product Collected by FDA," "Product Detained by FDA," or "Product Refused Entry by FDA," or similar wording should be considered as meeting the standard, "giving notice thereof to the owner or consignee." See 21 USC 381(a); 21 CFR 1.94.

  • ORA supports the six FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States.

  • In any event, training should have been in accordance with the ‘UK National Standards for Foster Care’ (National Standards)36 as published in 1999.

  • Purchaser acknowledges that the FDA Product and Establishment fees are due on or before October 1st 2012 for the fiscal year beginning on October 1st 2012 and lasting through September 30, 2013.

  • CBP also collected the Complete FDA Product Code in ACS to assist FDA in making admissibility decisions for FDA- regulated products.(Comment 10) Some commenterssupported the requirement for submission of the Complete FDA Product Code but requested clarification regarding the requirement that the code ‘‘ .

  • Regulatory StatusDevices for transcranial stimulation have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for diagnostic uses (FDA Product Code: GWF).


More Definitions of FDA Product

FDA Product means a Product that is approved by the FDA or any other Regulatory Authorities, including without limitation the SinuNase Formulation.
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FDA Product shall be a Product that is approved by the FDA or appropriate European authority for use in the Field.
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Related to FDA Product

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):