FDA Clearance definition

FDA Clearance means an application to the FDA for the sale or other distribution of FDA 510K small device for professional use and/or OTC for the Target System process , as well as all other FDA Clearances obtained by either LICENSOR or LICENSEE pursuant to this Agreement.

FDA Clearance means the 510(k) clearance received by WellSky from the Food and Drug Administration that authorizes the commercialization of the Regulated Licensed Software and sets forth the specific parameters of use for the Regulated Licensed Software on the Designated Platform.

FDA Clearance. The approval by the U.S. Food and Drug Administration for selling and marketing a particular product in the Territory.

Examples of FDA Clearance in a sentence

• The consideration for the shares issued to Wescor shall be the amounts contributed to MicroCor to fund the Wescor Funding Obligations incurred to the date of obtaining FDA Clearance.

• Upon the first completed production run of units of the Products for which FDA Clearance has been received and upon preparation of such units for sale (the "First Production"), MicroCor shall issue to Wescor, 700,000 new shares of MicroCor Stock.

• Upon obtaining FDA Clearance, MicroCor shall issue to Wescor, 500,000 new shares of MicroCor Stock.

• Wescor shall use its best efforts with all reasonable speed and efficiency to conduct and complete, or cause MicroCor to conduct and complete, such actions as are reasonably necessary to gather data and prepare a 510(k) Premarket Notification submission to the FDA covering the Product(s) and to obtain the necessary clearances from the FDA to market such Product(s) in the United States market ("FDA Clearance").

• After obtaining FDA Clearance of a Product, Wescor shall use its best efforts with all reasonable speed and efficiency to cause MicroCor to begin manufacturing, marketing and selling such Product in the market.

More Definitions of FDA Clearance

FDA Clearance means the issuance by the FDA of an order of substantial equivalence in response to a premarket notification submission made under section 510(k) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 et seq.

FDA Clearance means receipt by AMEDICA of all approvals (including pricing and reimbursement approvals), product and establishment licenses, registrations or authorizations of any kind of the United States Food and Drug Administration and any successor agency or authority thereto necessary for the marketing and sale of Products for use in AMEDICA’s Field of Use.

FDA Clearance means the later of (A) the date on which XXXXX obtains CE Xxxx Approval, (B) the date on which cCSAus Approval occurs; or (C) date on which PHMD has obtained 510(k) clearance from the FDA for the Licensed Product. PHMD shall advise XXXXX in writing of 510(k) clearance promptly following the date on which PHMD receives written notice from the FDA of such 510(k) clearance.

FDA Clearance means an application to the FDA for the sale or other distribution of FDA 510k small device for professional use and/or OTC for the Patent Target System process for the HIV I & II immuno assay HIV Phase III, as well as all other FDA Clearances obtained by either LICENSOR or LICENSEE pursuant to this Agreement.

FDA Clearance will mean the first date on which KCI receives FDA clearance to market in the U.S. Preissuance Products or Processes or Licensed Product or Process.

FDA Clearance means the receipt by the Licensee of a 510(k) clearance letter from the FDA submission for a Licensed Product.

FDA Clearance. [**]” shall mean a 501(k) clearance by the FDA for marketing and sale in the United States of the FSP Product developed hereunder, with a [************************************] indication and for use with the Robotic System.