510(k) Submission definition

510(k) Submission shall have the meaning set forth in the License Agreement.
Sample 1
510(k) Submission will mean acceptance by the U.S. FDA of an application for 510K clearance. As used herein, "acceptance" will mean that the U.S. FDA has received the application and assigned a control number for such application.
Sample 1
510(k) Submission means a premarket notification for a medical device under Section 510(k) of the Federal Food, Drug Product and Cosmetic Act of the United States which includes information to establish that the medical device is substantially equivalent to a legally marketed device. Depending upon the circumstance, the 510(k) Submission can include: (a) a traditional 510(k) submission; (b) a special 510(k) device modification submission; or (c) an abbreviated 510(k) submission.
Sample 1

Examples of 510(k) Submission in a sentence

  • Copies are available on the ASRB web site www.schizophreniaresearch.org.au Researchers must seek formal approval from the ASRB before varying any agreed upon research protocol, undertaking subsequent studies, or conducting additional follow-up research which utilises volunteers, samples or data provided by the ASRB.

  • Mi-­‐‑ chael Regize, How a 510(k) Submission Can Affect Your Patent, MED.

  • Bhd.PT 2609-2620, Batu 8,Jalan Changkat Jong, 36000 Teluk Intan, Perak, MalaysiaContact: Tel: +605-629 0000 Fax: +605-629 0001 510(k) Submission Prepared by: Muhammad Abdul RahmanRegulatory Affairs Officer Central Medicare Sdn.

  • This section is not applicable because there is not including any clinical performance data with this 510(k) Submission.

  • DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration [Docket No. FDA-2020-N-0625]Improving 510(k) Submission Preparation and Review: Voluntary Electronic Submission Template and Resource Pilot Program; Request for CommentsAGENCY: Food and Drug Administration, HHS.

  • The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical face masks– Premarket Notification [510(k)] Submission issued on March 5, 2004.

  • Please provide feedback on whether and how the excellence appraisal and real-world performance processes might be used to provide assurance for each of the elements listed in Table 4 below.Table 5 –Software-related Review Elements in a 510(k) Submission FDA will continue to build and refine this working model by considering public comments, incorporating comments received, as appropriate, and regularly seeking additional public input throughout the development of this program.

  • HeartBeam, Inc.By: /s/ Ryan McGuinnessBy: /s/ Alan Baumel Name: Ryan McGuinnessName: Alan BaumelTitle: Commercial GMTitle: Chief Operating Officer Page 6 of 6 HeartBeam Partners with Triple Ring Technologies to Co-Develop Telehealth Solution Device3D Vector ECG Collection Device Slated for FDA 510k Submission in the Fourth Quarter of 2022SANTA CLARA, CA – March 10, 202-2- HeartBeam, Inc.

  • The clustering guarantees a higher over- lap between the sentences as well as a word graph with fewer paths.

  • Non clinical tests were conducted and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 05, 2004.

Related to 510(k) Submission

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Electronic Submission means a successful submittal of Offeror’s proposal.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Planning Submission or “CAPS” or “Community Accountability Planning Submission” means the HSP Board approved planning document submitted by the HSP to the LHIN. The form, content and scheduling of the Planning Submission will be identified by the LHIN;

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • StarCompliance Code of Ethics application means the web-based application used to electronically pre-clear personal securities transactions and file many of the reports required herein. The application can be accessed via the AB network at: https://alliance-ng.starcompliance.com/.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;

  • IND means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Third-Party Filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.