Specific guidance definition

Specific guidance means guidance that provides information regarding postmarket surveillance for specific types or categories of devices or specific postmarket surveillance issues. This type of guidance may be used to supplement general guidance and may address such topics as the type of surveillance approach that is appropriate for the device and the postmarket surveillance question, sample size, or specific reporting requirements.
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Specific guidance means guidance that provides information regarding postmarket surveillance for specific types or categories of devices or spe- cific postmarket surveillance issues. This type of guidance may be used to supplement general guidance and may address such topics as the type of sur- veillance approach that is appropriate for the device and the postmarket sur- veillance question, sample size, or spe- cific reporting requirements.
Sample 1Sample 2
Specific guidance means guidance that provides information regarding postmarket surveillance for specific types or categories of devices or spe- cific postmarket surveillance issues. This type of guidance may be used to supplement general guidance and may address such topics as the type of sur- veillance approach that is appropriate VerDate Sep<11>2014 15:46 Jun 06, 2023 Jkt 259078 PO 00000 Frm 00202 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT PC31 Food and Drug Administration, HHS § 822.7 for the device and the postmarket sur- veillance question, sample size, or spe- cific reporting requirements.
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Examples of Specific guidance in a sentence

  • Specific guidance for policy implementation may be found in the associated Administrative Procedure(s).

  • Specific guidance on marking requirements should be obtained prior to procurement of commodities to be shipped, and as early as possible for project construction sites and other project locations.

  • Specific guidance, however, will not be provided to individual applicants at any time.

  • Specific guidance is provided at Part IV, Department of Labor Federal Register/Volume 68, No. 103, issued Thursday, May 29, 2003, and Department of Health and Human Services Federal Register/Volume 65, No. 169, August 30, 2000 and Department of Health and Human Services Federal Register Volume 68, Number 153, August 8, 2003.

  • Specific guidance on the need for additional documentation may be obtained from the organization’s SPO or in the references cited below.

  • Specific guidance, however, will not be provided to individual bidders at any time.

  • Specific guidance for the conduct of human gene transfer studies appears in Appendix M of the NIH Guidelines .

  • As a general rule, marking is not required for raw materials shipped in bulk (such as coal, grain, etc.), or for semifinished products which are not packaged.(b) Specific guidance on marking require- ments should be obtained prior to procure- ment of commodities to be shipped, and as early as possible for project construction sites and other project locations.

  • Specific guidance will be provided via Grant Solutions well in advance of the application due date.

  • Specific guidance on a section or subsection in the Instrument follows any general guidance.

Related to Specific guidance

  • DOL Guidance means the Department of Labor (DOL) Guidance entitled: “Guidance for Executive Order 13673, ‘Fair Pay and Safe Workplaces’”. The DOL Guidance was initially published in the Federal Register on August 25, 2016, and significant revisions will be published for public comment in the Federal Register. The DOL Guidance and subsequent versions can be obtained from www.dol.gov/fairpayandsafeworkplaces.

  • the Guidance means the guidance on the creation and operation

  • Uniform Guidance means the Office of Management and Budget Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, which supersedes requirements from OMB Circulars A-21, A-87, A-110, and A-122, OMB Circulars A-89, A-102, and A-133, and the guidance in Circular A-50 on Single Audit Act follow-up. The terms and conditions of the Uniform Guidance flow down to Awards to Subrecipients unless the Uniform Guidance or the terms and conditions of the Federal Award specifically indicate otherwise.

  • Commission Guidance means (i) any publicly available written guidance or rule of general applicability of the Securities and Exchange Commission staff or (ii) written comments, requirements or requests of the Securities and Exchange Commission staff to the Company in connection with the review of a Registration Statement.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • SEC Guidance means (i) any publicly-available written or oral guidance of the Commission staff, or any comments, requirements or requests of the Commission staff and (ii) the Securities Act.

  • Uniform Network Code means the uniform network code as defined in Standard Special Condition A11(6) of National Grid’s transporters licence, as such code may be amended from time to time in accordance with the terms thereof.

  • Technical Guidance Letter or “TGL” means an instruction, clarification, or interpretation of the requirements of the Contract, issued by the System Agency to the Grantee.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Application Program means a computer program which is intended to be executed for the purpose of performing useful work for the user of the information being processed. Application programs are developed or otherwise acquired by the user of the Hardware/Software system, but they may be supplied by the Contractor.

  • Uniform application means the current version of the national association of insurance commissioners uniform application for resident and nonresident insurance producer licensing.

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

  • Branding Guidance means the Authority's guidance in relation to the use of branding;

  • Compliance schedule means a schedule of events, by date, which will result in compliance with these regulations.

  • General Anti-Abuse Rule means (a) the legislation in Part 5 of the Finance Act 2013; and (b) any future legislation introduced into parliament to counteract tax advantages arising from abusive arrangements to avoid national insurance contributions;

  • Mobile Application means a specialized software program downloaded onto a wireless communication device.

  • Program Parameter means, in respect of a program, the provincial standards (such as operational, financial or service standards and policies, operating manuals and program eligibility), directives, guidelines and expectations and requirements for that program;

  • Step therapy protocol means a protocol or program that establishes the specific

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;

  • Software Updates means the Software releases, service packs, build updates or emergency fixes released from time to time in accordance with the Vocera’s update policy for such Software.

  • Guidance means any guidance issued or updated by the UK Government from time to time in relation to the Regulations;

  • Software Application means a digital product or service as defined in Article 2, point 13, of Regulation (EU) …/… [on contestable and fair markets in the digital sector (Digital Markets Act)];

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Substance abuse treatment means outpatient or inpatient services or participation in Alcoholics Anonymous or a similar program.

  • Project specific information means such part of the Instructions to Consultants used to reflect specific project and assignment conditions.

  • the Approved Guidance means such guidance on the obtaining, recording and maintaining of information about costs and on the breaking down and allocation of costs by reference to Approved Reporting Currencies as may be published by Monitor; “Approved ReportingCurrencies” means such categories of cost and other relevant information as may be published by Monitor; “other relevant information” means such information, which may include quality and outcomes data, as may be required by Monitor for the purpose of its functions under Chapter 4 (Pricing) in Part 3 of the 2012 Act.