Significance of Guidance Sample Clauses

Significance of Guidance. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on clinical study designs for surgical ablation devices for treatment of atrial fibrillation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
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Significance of Guidance. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Deciding When to Submit a 510(k) for a Software Change to an Existing Device.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
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Related to Significance of Guidance

  • Interpretation & Application of Guidelines It is jointly agreed that the site representatives (union and management) are empowered to implement the guidelines as per the scope provided. It is jointly agreed that refresher training to explain the interpretation and application of the inclement weather clauses is to be conducted to ensure correct use. Unless these guidelines are followed, the employer will not be required to pay for lost time through inclement weather and the Disputes Board will be so briefed.

  • Penalties for Non-compliance to Service Level Agreement Where the Supplier/Service Provider fails to deliver the Goods/Services within the agreed and accepted milestone timelines and provided that the cause of the delay was not due to a fault of Transnet, penalties shall be imposed at …………………………………………………… .

  • Conflict of Interest; Governmental Conduct Act A. The Contractor represents and warrants that it presently has no interest and, during the term of this Agreement, shall not acquire any interest, direct or indirect, which would conflict in any manner or degree with the performance or services required under the Agreement.

  • STATE’S ABILITY TO MODIFY SCOPE OF MASTER CONTRACT Subject to mutual agreement between the parties, Enterprise Services reserves the right to modify the goods and/or services included in this Master Contract; Provided, however, that any such modification shall be effective only upon thirty (30) days advance written notice; and Provided further, that any such modification must be within the scope of this Master Contract.

  • Effect of Addenda, Bulletins, and Change Orders No special implication, interpretation, construction, connotation, denotation, import, or meaning shall be assigned to any provision of the Contract Documents because of changes created by the issuance of any (1) Addendum, (2) Bulletin, or (3) Change Order other than the precise meaning that the Contract Documents would have had if the provision thus created had read originally as it reads subsequent to the (1) Addendum, (2) Bulletin, or (3) Change Order by which it was created.

  • Notification of Modifications of Licensed Materials From time to time Publisher may add, change, or modify portions of the Licensed Materials, or migrate the Licensed Materials to other formats. When such changes, modifications, or migrations occur, the Licensor shall give notice of any such changes to Licensee as soon as is practicable, but in no event less than sixty (60) days in advance of modification. Such a notice may also be given directly by the Publisher to the Licensee. If any of the changes, modifications, or migrations renders the Licensed Materials substantially less useful to the Licensee, the Participating Institutions or their Authorized Users, the Licensee may seek to terminate this Agreement for breach pursuant to the termination provisions of this Agreement in Section XI, below.

  • CONCLUSION OF NEGOTIATIONS A. The State and MSEA-SEIU agree that this Agreement concludes all collective negotiations during its term. Neither party will during the term of this Agreement seek to unilaterally modify its terms through legislation or other means which may be available to them.

  • Application and Submission Information In addition to the application and submission language discussed in PART II: Section I, you must include the following in your application:

  • Submission of Grievance Information a) Upon appointment of the arbitrator, the appealing party shall within five days after notice of appointment forward to the arbitrator, with a copy to the School Board, the submission of the grievance which shall include the following:

  • No Expectation of Privacy The Student and parent/guardian signing below agree that if the Student uses the Internet through the District’s access, that the Student waives any right to privacy the Student may have for such use. The Student and the parent/guardian agree that the district may monitor the Student’s use of the District’s Internet Access and may also examine all system activities the Student participates in, including but not limited to e-mail, voice, and video transmissions, to ensure proper use of the system. The District may share such transmissions with the Student’s parents/guardians.

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