Postmarket surveillance definition

Postmarket surveillance means the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.
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Postmarket surveillance means the active, systematic, scientifically valid collection, analysis, and interpretation
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Examples of Postmarket surveillance in a sentence

  • Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion.

  • For example, phen-fen was popular only between 1992 and 1997.297 In that time at least 285,000 people had heart valve damage from taking the drug combination.298 Post-market surveillance may catch adverse effects more quickly than they were discovered in the phen-fen situation.

  • Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada.

  • Post-market surveillance can take place by way of a review of manufacturer’s technical documentation sent in to the HPRA and/or by audit at the manufacturer’s premises.

  • Postmarket surveillance and studies of consumer health should provide data with respect to the health risks of the MRTP, including the effect the product has on tobacco-related morbidity and mortality.

  • Post-market surveillance will be investigated through complaint history, surgeon feedback, and/or clinical evaluations of both WMT and related competitor products.

  • Postmarket surveillance and studies of consumer behavior should provide data with respect to the effect the product’s marketing has on whether current tobacco users switch to the product from their usual product, whether current tobacco users continue using the product, whether current tobacco users who would otherwise cease all tobacco use switch to the product instead, and whether non-users start using the product.

  • Post-market surveillance is a WHO post-qualification activity which includes reactive and proactive measures, through complaint reporting and post-shipment/pre-distribution lot testing.

  • Post-market surveillance of implants: Implants play a major role in modern spine surgery.

  • Postmarket surveillance is not a substitute for obtaining the necessary premarket information to support 510(k) clearance, PMA, HDE, or PDP approval, or grant of de novo order.

Related to Postmarket surveillance

  • market surveillance means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

  • Surveillance means monitoring and observation of the disposal site for purposes of visual detection of need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

  • market surveillance authority means an authority of a Member State responsible for carrying out market surveillance on its territory;

  • Police Department means the Police Department of the City and County of San Francisco.

  • Verified mail means any method of mailing that is offered by

  • Head of the Department means the administrative head of the department or the organization;

  • Department Chair means the chair of a department or the director of a program.

  • Agencies means the Department, the Agency for International Develop- ment (AID), the International Commu- nication Agency (USICA), the Foreign Agricultural Service (FAS), and the Foreign Commercial Service (FCS).

  • Business reply mail envelope means an envelope that may be mailed free of

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • District and high school graduation report means a report of the number of pupils, excluding adult education participants, in the district for the immediately preceding school year, adjusted for those pupils who have transferred into or out of the district or high school, who leave high school with a diploma or other credential of equal status.

  • Help Desk means the contact point established by Project Co in respect of the Help Desk Services for the notification of Demand Requisitions, the occurrence of Events and other matters arising in relation to the provision of Services;

  • BBB by Standard & Poor's or "Baa2" by Moody's, as promptly as practicabxx xxx in any case within 90 days of the event, the Master Servicer shall, at its expense, either

  • Generating Market Buyer means an Internal Market Buyer that is a Load Serving Entity that owns or has contractual rights to the output of generation resources capable of serving the Market Buyer’s load in the PJM Region, or of selling energy or related services in the PJM Interchange Energy Market or elsewhere.

  • USDA means the United States Department of Agriculture.

  • Agency(ies) means any government regulatory authority or authorities in the world responsible for granting approval(s), clearance(s), qualification(s), license(s), or permit(s) for any aspect of the research, Development, manufacture, marketing, distribution, or sale of a Product. The term “Agency” includes, without limitation, the United States Food and Drug Administration (“FDA”).

  • Fire Department means an organized fire department as that term is defined in section 1 of the fire prevention code, 1941 PA 207, MCL 29.1.

  • Department sample means liquor that is placed in the possession of the

  • Maintenance Supervisor (Tradesperson) means an employee who has trade qualifications and has overall responsibility for maintenance at the place of employment and may be required to supervise other maintenance staff.

  • Telemarketing means any plan, program, or campaign which is conducted to induce the purchase of goods or services by use of one or more telephones, and which involves a telephone call, whether or not covered by the Telemarketing Sales Rule.

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • Nationwide Mortgage Licensing System and Registry means a mortgage licensing system developed and maintained by the conference of state bank supervisors and the American association of residential mortgage regulators for the licensing and registration of licensed mortgage loan originators.

  • Rebate Analyst means the person or firm selected by the Issuer to calculate the Rebate Amount, which person or firm shall either be a firm of attorneys or independent certified public accountants with expertise in the calculation of the Rebate Amount.

  • Helpdesk means the helpdesk facility provided by GBG to handle enquiries and administration for the Service.

  • Industrial maintenance coating means a high performance architectural coating, including primers, sealers, undercoaters, intermediate coats, and topcoats formulated for application to substrates, including floors, exposed to one or more of the following extreme environmental conditions listed below and labeled “For industrial use only;” “For professional use only;” “Not for residential use;” or “Not intended for residential use.”