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

• Preparations for FDA Clearance Submissions and Design for ManufacturingUp to this point, we have focused primarily on research and development of our first two Products.

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

• 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.

• Downtimes of e-beam and x-ray equipment will show country-by-country variation.Regulatory Costs and Considerations FDA Clearance and SterilizationThe FDA requires virtually all new medical devices to meet certain requirements before they can be sold or marketed in the United States.

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. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act of 1933, as amended.

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 a notification from the FDA finding the Device can be marketed and sold in the United States.

FDA Clearance means 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.

FDA Clearance means a clearance issued by the FDA respectively for the GI Panel Assay or the GI Panel Assay, after review and approval of the Premarket Notification Submission of the GI Panel Assay or the RI Panel Assay, as applicable, under Section 510(k) of the U.S. Food, Drug and Cosmetic Act and 21 CFR § 807.100 et seq., or any equivalent clearance that may replace this clearance.”