Direct accreditation definition

Direct accreditation means accreditation of a third-party auditor/certification body by FDA and is a term used in section 808(b)(1)(A)(ii) of the FD&C Act when describing FDA accreditation of third-party auditors/certification bodies, without the involvement of a recognized accreditation body. The distinction between direct accreditation and accreditation by an FDA- recognized accreditation body is relevant for some provisions of this rule. For example, under proposed § 1.656(b), a directly accredited auditor/certification body must send its annual self- assessment reports to FDA, while an auditor/certification body accredited by a recognized accreditation body must submit its annual self-assessment reports to the accreditation body, who is responsible for monitoring and ensuring its accredited auditors/certification bodies take timely and effective corrective actions, where necessary. FDA will access the accredited
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Direct accreditation means accreditation of a third-party auditor/certification
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Examples of Direct accreditation in a sentence

  • Direct accreditation outcomes were defined as specific actions taken by organizations during the process of becoming certified to meet GFAS standards of best practices.

  • They could thus distort both the pattern of trade and the size structure of industry by favouring larger firms, for whom the fixed compliance costs and burdens are smaller in proportion of total costs and revenues.

Related to Direct accreditation

  • Accreditation means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;

  • Accreditation body means an entity that has been approved by FDA to accredit mammography facilities.

  • national accreditation body means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

  • Joint Commission means the accrediting body whose standards are referred to in these Bylaws.

  • Health Care Permits means any and all permits, licenses, authorizations, certificates, certificates of need, accreditations and plans of third-party accreditation agencies that are (a) necessary to enable any Borrower to operate any health care facility or participate in and receive payment under any Government Reimbursement Program or other Third Party Payor Arrangement, as applicable, or otherwise continue to conduct its business as it is conducted on the Closing Date, or (b) required under any Health Care Law.

  • JCAHO means the Joint Commission on Accreditation of Healthcare Organizations.

  • Insurance holding company system means a group of two or more affiliated persons, at least one of whom is an insurer.

  • Applicable Insurance Regulatory Authority means, when used with respect to any Insurance Subsidiary, the insurance department or similar administrative authority or agency located in (x) the state or other jurisdiction in which such Insurance Subsidiary is domiciled or (y) to the extent asserting regulatory jurisdiction over such Insurance Subsidiary, the insurance department, authority or agency in each state or other jurisdiction in which such Insurance Subsidiary is licensed, and shall include any Federal insurance regulatory department, authority or agency that may be created in the future and that asserts regulatory jurisdiction over such Insurance Subsidiary.

  • Licensure means the status of a licensee when OCCL issued a child care license when the applicant demonstrated compliance with these regulations and applicable codes, regulations, and laws.

  • Medicare Provider Agreement means an agreement entered into between CMS or other such entity administering the Medicare program on behalf of CMS, and a health care provider or supplier under which the health care provider or supplier agrees to provide services for Medicare patients in accordance with the terms of the agreement and Medicare Regulations.

  • Non-participating private hospital means a hospital that does not have a hospital purchaser provider agreement with Latrobe. (If you use a non-participating private hospital you may incur a large out-of- pocket expense.)

  • Health care system means any public or private entity whose function or purpose is the management of, processing of, enrollment of individuals for or payment for, in full or in part, health care services or health care data or health care information for its participants;

  • Basic health care services means in and out-of-area emergency services, inpatient hospital and

  • Health Care Authority or “HCA” means the Washington State Health Care Authority, any division, section, office, unit or other entity of HCA, or any of the officers or other officials lawfully representing HCA.

  • Authorizations means all filings, recordings, and registrations with, and all validations or exemptions, approvals, orders, authorizations, consents, franchises, licenses, certificates, and permits from, any Governmental Authority.

  • Multistate licensure privilege means a legal authorization associated with a multistate license permitting the practice of nursing as either a registered nurse (RN) or LPN/VN in a remote state.

  • COVERED HEALTHCARE SERVICES means any service, treatment, procedure, facility, equipment, drug, device, or supply that we have reviewed and determined is eligible for reimbursement under this plan.

  • Health care services means services for the diagnosis, prevention, treatment, cure, or relief of a health condition, illness, injury, or disease.

  • Participating private hospital means a hospital that has a hospital purchaser provider agreement with Latrobe.

  • Government Entities means collectively, the United States of America or any other nation, any state or other political subdivision thereof, or any entity exercising executive, legislative, judicial, regulatory or administrative functions of government, including any court, in each case having jurisdiction over the Company.

  • Government Approvals means all permits, licenses, authorisations, consents, clearances, decrees, waivers, privileges, approvals from and filing with government instrumentalities necessary for the development, construction and operation of the Work.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • Educational entity means a public school district,

  • Insurance Regulator means, with respect to any jurisdiction, the Governmental Authority charged with the supervision of insurance companies in such jurisdiction.

  • Non-Participating Hospice Care Program Provider means a Hospice Care Program Provider that either: (i) does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield to provide services to participants in this benefits program, or; (ii) a Hospice Care Program Provider which has not been designated by a Blue Cross and/or Blue Shield Plan as a Participating Provider Option program.

  • Regulatory Flood Protection Elevation means the “Base Flood Elevation” plus the “Freeboard”. In “Special Flood Hazard Areas” where Base Flood Elevations (BFEs) have been determined, this elevation shall be the BFE plus two (2) feet of freeboard. In “Special Flood Hazard Areas” where no BFE has been established, this elevation shall be at least two (2) feet above the highest adjacent grade.