Medical Device Laws definition
Medical Device Laws means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. and regulations promulgated by the FDA thereunder, including those requirements for medical devices relating to nonclinical research, clinical research, good clinical practices, good laboratory practices, investigational use, premarket notification, premarket approval, establishment registration, device listing, clinical trial registration and reporting, Quality System Regulation, record keeping, labeling, advertising, device importation and exportation, adverse event reporting, recalls and reporting of corrections and removals, and all similar applicable Laws promulgated by other Governmental Authority outside the United States.
Medical Device Laws means all applicable requirements of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., all applicable regulations promulgated by the FDA related to medical devices including those relating to nonclinical research, clinical research, good clinical practices, good laboratory practices, investigational use, premarket notification, premarket clearance or approval, establishment registration, device listing, clinical trial registration and reporting, Quality System Regulation, record keeping, labeling, promotion, advertising, informed consent, device importation and exportation, adverse event reporting, recalls and reporting of corrections and removals, as applicable, and all similar applicable Laws promulgated by other Governmental Entities outside the United States.
Medical Device Laws has the meaning given to that term in Section 4.28(a).
Examples of Medical Device Laws in a sentence
The ScriptSwitch System is, at Acceptance by Client in accordance with Clause 5.8, compliant with the then current Applicable Medical Device Laws.
Each of the Company Products is the subject of an appropriate Regulatory Authorization, as required under Medical Device Laws, and duly held by the Company.
More Definitions of Medical Device Laws
Medical Device Laws means (a) the Federal Food, Drug and Cosmetic Act and all acts amending or supplementing such act, (b) the Fair Packaging and Labeling Act, (c) the Federal Trade Commission Act, and (d) all current and future amendments and successor Laws to any of the foregoing, and all regulations and rules promulgated from time to time thereunder.
Medical Device Laws has the meaning set forth in Section 3.20.
Medical Device Laws means all applicable requirements of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., all applicable regulations promulgated by the FDA related to medical devices including those relating to nonclinical research, clinical research, good clinical practices, good laboratory practices, investigational use, premarket notification, premarket approval, establishment registration, device listing, clinical trial registration and reporting, Quality System Regulation, record keeping, labeling, advertising, device importation and exportation, adverse event reporting, recalls and reporting of corrections and removals, as applicable, and all similar applicable Laws promulgated by other Governmental Entities outside the United States.