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 ASSIGNOR or ASSIGNEE 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

• Mediware represents and warrants to Customer that (a) the Licensed Software has received 510(k) clearance from the Food and Drug Administration (FDA) as blood establishment computer software; and (b) for a period of six (6) months following the date hereof, the Licensed Software will perform the functions set forth in the FDA Clearance in all material respects.

• PHMD shall have seventy-five (75) days in which to assimilate the technology and become ready to produce Licensed Product by FDA Clearance.

• The Parties agree that so long as the Licensed Software is a medical device regulated by the Food and Drug Administration (“Regulated Licensed Software”), the license granted in this Section 2 is conditioned on Customer’s Validation and use of the Licensed Software on the Designated Platform in conformance with the FDA Clearance.

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 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 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 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 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.”