Device Regulatory Matters Clause Samples

Device Regulatory Matters. (a) Except as set forth on Schedule 3.22(a), each of the Group Companies, is, and since January 1, 2016, has been, in compliance, in all material respects, with all applicable Device Regulatory Laws. Except as set forth in Schedule 3.22(a), each of the Group Companies has not, at any time since January 1, 2016, received written notice of any pending action, suit, proceeding, hearing, investigation, claim, demand or notice relating to its business alleging any failure to so comply with applicable Device Regulatory Law. Except as set forth on Schedule 3.22(a), the Group Companies have not received, since January 1, 2016, any written notice of inspectional observations or adverse findings, establishment inspection reports, “warning letters,” “untitled letters,” recalls, field notifications, seizure or similar correspondence or notice from any Governmental Entity alleging or asserting material non-compliance with any applicable Device Regulatory Laws or Device Permits, and there is no such action or proceeding pending or, to the Knowledge of the Company, threatened. (b) All manufacturing operations for the Group Companies conducted by or on behalf of the Group Companies have, at all times since January 1, 2016, been conducted in compliance in all material respects with the Quality System Regulation (21 CFR Part 820) and equivalent requirements applicable in the European Union pursuant to the Device Regulatory Laws. No Group Company’s product that was manufactured or sold since January 1, 2016, is or was adulterated within the meaning of 21 U.S.C. § 351, misbranded within the meaning of 21 U.S.C. § 352, seized, detained, subject to a suspension of manufacturing, distribution, or marketing, was deemed to compromise the health and/or safety of patients, users or, where applicable, other persons within the meaning of Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC or has been recalled, is subject to a recall, or is subject to imminent plans to issue a recall and to the Knowledge of the Company, there are no facts or circumstances that would be reasonably likely to cause: (i) any such product to become adulterated or misbranded; (ii) the seizure, detention, or suspension of manufacturing, distribution, or marketing of any such product; (iii) a change in the labeling or classification of any such product; (iv) the termination, seizure or suspension of marketing of any such product; or (v) a recall of any such product. (i) The Group Companies, have, a...