IDE Approval definition

IDE Approval means approval of the Assay by the FDA of an Investigational Device Exemption.
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IDE Approval means approval by the FDA that the Product received Investigational Device Exemption.
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IDE Approval means the FDA has approved the IDE Application such that Buyer may initiate the PMA US Pivotal Study protocol set forth in the IDE Application subject to compliance with the following requirements: (a) labeling according to 21 CFR 812.5; (b) distribution according to 21 CFR 812.43(b); (c) informed consent according to 21 CFR 50; (d) monitoring according to 21 CFR 812.46; (e) prohibitions according to 21 CFR 812.7; and (f) records and reports according to 21 CFR 812.140 and 21 CFR 812.150.
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Examples of IDE Approval in a sentence

  • Ark shall perform analytical Verification studies of the Assay to support IDE Approval, and shall timely provide all necessary information and materials and provide other cooperation reasonably required for the IDE preparation, submission, and Approval, including without limitation, those responsibilities allocated to Ark as set forth in the SOW.

  • To determine whether a device study is significant risk or non-significant risk, the IRB will: [1] Review the risk assessments and rationale used by the sponsor and/or the investigator (including any FDA IDE Approval Letter), description of the device, reports of prior investigations, subject selection criteria, monitoring procedures, and nature of the harm that might result from use of the device.

  • You may send a Q-submission to the Document Control Center for review by the appropriate Review Division to receive more specific information about your specific testing recommendations (for CDRH, see IDE Approval Process6; for CBER, use contact information supplied on the 513(g) Request for Information response letter.

  • No. 27-19.) Since the AAA required the payment of initial fees to proceed, the AAA neither assigned an arbitrator to the claims, nor designated a locale for arbitration.

  • This work was performed by the state police and the Millbury and Sutton town police.

  • In the first quarter of fiscal 2002, we received FDA IDE Approval for two 4-center, 30 patient pilot studies of left cervical VNS (the same VNS as used in epilepsy and depression) as a treatment for anxiety disorders and chronic migraine headache.

  • Structural Heart Studies: 6 • Average IDE Approval Time = 38 days• Close Sponsor-Investigator-FDA CollaborationSource: MDIC Survey of EFS Structural Heart Sponsor Participants – Results as of 6/9/2017II.

  • Such completely unparticularized suspicion–with regard to both description of the suspected perpetrators and the type of criminal activity suspected–does not even rise to the level of a “hunch.”It appears to the Court that Officer Barrington acted upon the information she received from Mr. Talley by simply stopping the first two black men she encountered who she didn’t know to be from Dandridge.


More Definitions of IDE Approval

IDE Approval means approval of an investigational device exemption application filed with the United States Food and Drug Administration, or the equivalent regulatory approval in Japan, Canada or any western European country.
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IDE Approval means FDA's approval of an IDE Application or an IDE deemed approved pursuant to the requirements set forth in 21 C.F.R. Part 812 permitting distribution of an investigational product.
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IDE Approval shall have the meaning set forth in the Development Agreement.
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IDE Approval means the receipt of an FDA Letter stating that a Product has achieved unconditional pivotal FDA Investigational Device Exemption approval (i.e., “full approval”) that enables the conduct of a pivotal clinical trial: (a) with respect to the PTCA-DCB Product, for coronary use of the PTCA-DCB Product that is designed to achieve Premarket Approval Application approval for a coronary use with an in stent restenosis indication; and/or (b) with respect to the PTA-DCB Product, for use in superficial femoral artery of the PTA-DCB that is designed to achieve Premarket Approval Application approval for an SFA indication.
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IDE Approval means the FDA has approved the IDE Application such that Buyer may initiate the PMA US Pivotal Study protocol set forth in the IDE Application subject to compliance with the following requirements: (a) labeling according to 21 CFR 812.5; (b) distribution according to 21 CFR 812.43(b); (c) informed consent according to 21 CFR 50; (d) monitoring according to 21 CFR 812.46; (e) prohibitions according to 21 CFR 812.7; and(f) records and reports according to 21 CFR 812.140 and 21 CFR 812.150.
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Related to IDE Approval

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • type-approval means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

  • Requisite Approval means the affirmative vote of the holders of at least a majority of the shares of outstanding Company Common Stock and outstanding Company Preferred Stock voting as a single class.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • FCC Approval means the FCC’s grant of the FCC Applications; provided that the possibility that an appeal, request for stay, or petition for rehearing or review by a court or administrative agency may be filed with respect to such grant, or that the FCC may reconsider or review such grant on its own authority, shall not prevent such grant from constituting FCC Approval for purposes of the Plan.

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • Approval means the prior written consent of the Authority and "Approve" and "Approved" shall be construed accordingly;

  • Prior Approval means written ap- proval by an authorized official evi- dencing prior consent.

  • Special Approval means approval by a majority of the members of the Conflicts Committee.

  • Requisite Shareholder Approval shall have the meaning set forth in Section 4.3(a).

  • Shareholder Approval Date means the date on which this Plan is approved shareholders of the Company eligible to vote in the election of directors, by a vote sufficient to meet the requirements of Code Sections 162(m) (if applicable) and 422, Rule 16b-3 under the Exchange Act (if applicable), applicable requirements under the rules of any stock exchange or automated quotation system on which the Shares may be listed on quoted, and other laws, regulations and obligations of the Company applicable to the Plan.

  • Shareholder Approval means such approval as may be required by the applicable rules and regulations of the Nasdaq Stock Market (or any successor entity) from the shareholders of the Company with respect to the transactions contemplated by the Transaction Documents, including the issuance of all of the Shares and Warrant Shares in excess of 19.99% of the issued and outstanding Common Stock on the Closing Date.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Required Shareholder Approval has the meaning in Section 2.20.

  • Works Approval means this Works Approval numbered W5894/2015/1 and issued under the Act; and

  • Board Approval has the meaning set out in Section 2.2(a)(ii);

  • Government Approval means (a) any authorization, consent, approval, license, lease, ruling, permit, tariff, rate, certification, waiver, exemption, filing, variance, claim, order, judgment or decree of, by or with, (b) any required notice to, (c) any declaration of or with or (d) any registration by or with, any Government Authority.

  • Conditional approval means a time-limited status that results when an approved nursing education program has failed to maintain requirements as set forth in this chapter.

  • Approval Authority means the authority of a Member State with competence for all aspects of the approval of a type of vehicle, system, component or separate technical unit or of the individual approval of a vehicle; for the authorisation process, for issuing and, if appropriate, withdrawing approval certificates; for acting as the contact point for the approval authorities of other Member States; for designating the technical services and for ensuring that the manufacturer meets his obligations regarding the conformity of production;

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Requisite Stockholder Approval means the affirmative vote of the holders of a majority of that company’s issued and outstanding shares entitled to vote on the Merger actually voting in favor of this Agreement and the Merger.