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 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.

  • 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.

  • On or before the fifth Business Day following (i) any FDA Payment Trigger Date and (ii) July 1, 2019, Parent will deliver to the Rights Agent a notice (the “FDA Approval Payment Notice”) indicating whether FDA Product Approval was achieved, and if achieved, whether FDA Preferred Product Label Approval was achieved.

  • Concentration of Use by FDA Product Category: Source Amino Acids.

  • 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.

  • Concentration of use by FDA Product Category: Citrus Derived Ingredients.

  • 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).

  • Accentia will seek approval of the FDA and other Regulatory Authorities for an encochleated form of FDA Product using the cochleate technology licensed by Accentia under the BDSI License Agreement.

  • Set forth on Schedule 5.12 is a report of the Seller's aggregate gross revenue, deductions, net sales, cost of goods sold (including FDA Product Fees for 2010 and 2011), gross profit, FDA Product Fees (reported separately for 2009 only), coupon reimbursement and all other direct and indirect operating costs in respect of the Product for (i) the twelve (12) month periods ended December 31, 2009 and December 31, 2010, and (ii) the two (2) month period ended February 28, 2011.


More Definitions of FDA Product

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 a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • 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, 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.”

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • 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 any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • 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 reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Licensed Compound means [***].

  • 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 and on a country-by-country basis, a product that [***].

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