IDE definition

IDE means the Investigational Device Exemption application process by which the United States Food and Drug Administration exempts medical device companies from the Federal statute that prohibits an unapproved device from being shipped in interstate commerce.

IDE means an Investigational Device Exemption application, as defined in Title 21 of the United States Code of Federal Regulations, filed with the FDA or an equivalent foreign filing.

IDE means an investigational device exemption issued by the FDA.

Examples of IDE in a sentence

• The IDE is a government entity and it is understood and agreed that the IDE’s payments herein provided for shall be paid from State of Idaho legislative appropriations.

• Unless otherwise allowed by the State in this Agreement, Contractor shall not, without written approval from the IDE, enter into any subcontract relating to the performance of this Agreement or any part thereof.

• The Contractor shall not be permitted to act or speak for the IDE in any capacity unless the IDE specifically requests or authorizes in writing the Contractor to do so.

• Any publicity given to the program or services provided herein, including, but not limited to, notices, information, pamphlets, press releases, research, reports, signs, and similar public notices prepared by or for Contractor and related to the services and work to be performed under this Agreement, shall identify the IDE as the sponsoring agency and shall not be released without prior written approval of the IDE.

• Provision of workers’ compensation insurance by the IDE under this provision shall be in the name of the Contractor as employer and shall not alter the independent contractor status of Contractor under the Agreement.

More Definitions of IDE

IDE means an application, including an application filed with a Regulatory Authority, for authorization to commence human clinical studies, including (a) an Investigational Device Exemption as defined in the FD&C Act or any successor application or procedure filed with the FDA, (b) an abbreviated IDE as specified in FDA regulations in 21 C.F.R. § 812.2(b), (c) any equivalent of a United States IDE in other countries or regulatory jurisdictions, (d) all amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing and (e) all related documents and correspondence thereto, including documents and correspondence with Institutional Review Boards (IRBs).

IDE means an application, including an application filed with any Regulatory Authority, for authorization to commence human clinical studies with respect to any Device, including (i) an Investigational Device Exemption as defined in the FD&C Act or any successor application or procedure filed with the FDA, (ii) an abbreviated Investigational Device Exemption as specified in FDA regulations in 21 C.F.R. § 812.2(b), (iii) any equivalent of any of the foregoing pursuant to or under any non-U.S. country or regulatory jurisdiction, (iv) all amendments, variations, extensions and renewals of any of the foregoing that may be filed with respect thereto, and (v) all related documents and correspondence thereto, including documents and correspondence with Institutional Review Boards, whether U.S. or the non-U.S. equivalent.

IDE means Investigational Device Exemption, as such term is used in the FD&C.

IDE means an application, including an application filed with any Regulatory Authority, for authorization to commence human clinical studies with respect to any Device, including (a) an Investigational Device Exemption as defined in the FD&C Act or any successor application or procedure filed with the FDA, (b) an abbreviated Investigational Device Exemption as specified in FDA regulations in 21 C.F.R. § 812.2(b), (c) any equivalent of any of the foregoing pursuant to or under any non‑United States country or regulatory jurisdiction, (d) all amendments, variations, extensions and renewals of any of the foregoing that may be filed with respect thereto, and (e) all documents and correspondence with Institutional Review Boards, whether United States or non‑United States, or equivalent.

IDE an application, including an application filed with a Governmental Authority, for authorization to commence human clinical studies, including (a) an Investigational Device Exemption as defined in the FD&C Act or any successor application or procedure filed with the FDA, (b) an abbreviated IDE as specified in FDA regulations in 21 C.F.R. § 812.2(b), (c) any equivalent of a United States IDE in other countries or regulatory jurisdictions, (d) all amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing and (e) all related documents and correspondence thereto, including documents and correspondence with institutional review boards or IECs.

IDE has the meaning specified in Section 4.17(d) hereof.

IDE means integrated development environment.