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CFR - Code of Federal Regulations Title 21 complaint definition

CFR - Code of Federal Regulations Title 21 FDA Home Medical Devices Databases -

The information on this page is current as of April 1 2016 .

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search Help | More About 21CFR [Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2016] [CITE: 21CFR820.3]


TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 820 -- QUALITY SYSTEM REGULATION Subpart A--General Provisions Sec. 820.3 Definitions. (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394)). All definitions in section 201 of the act shall apply to the regulations in this part. (b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. (c) Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. (d) Control number means any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined. (e) Design history file ( DHF ) means a compilation of records which describes the design history of a finished device. (f) Design input means the physical and performance requirements of a device that are used as a basis for device design. (g) Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record. (h) Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. (i) Device history record ( DHR ) means a compilation of records containing the production history of a finished device. (j) Device master record ( DMR ) means a compilation of records containing the procedures and specifications for a finished device. (k) Establish means define, document (in writing or electronically), and implement. (l) Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. (m) Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. (n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system. (o) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions. (p) Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer. (q) Nonconformity means the nonfulfillment of a specified requirement. (r) Product means components, manufacturing materials, in- process devices, finished devices, and returned devices. (s) Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance. (t) Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives. (u) Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. (v) Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. (w) Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use. (x) Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. (y) Specification means any requirement with which a product, process, service, or other activity must conform. (z) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. (1) Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. (2) Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s). (aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. (bb) Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in 1271.3(d) of this chapter that does not meet the criteria in 1271.10(a) and that is also regulated as a device. (cc) Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of 830.20 of this chapter. A unique device identifier is composed of: (1) A device identifier --a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and (2) A production identifier --a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device: (i) The lot or batch within which a device was manufactured; (ii) The serial number of a specific device; (iii) The expiration da IWC-Saint-Exupery/IWC-Saint-Exupery/IWC-Saint-Exupery/IWC-Saint-Exupery/rolex-watches-price-in-india-ebay-rid-0.html. moncler baby snowsuit ukte of a specific device; (iv) The date a specific device was manufactured. (v) For an HCT/P regulated as a device, the distinct identification code required by 1271.290(c) of this chapter. (dd) Universal product code (UPC) means the product identifier used to identify an item sold at retail in the United States. -
complaint definition

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mens black moncler t shirt Definition of complaints What does the word complaints mean? Find synonyms, antonyms and the meaning of the word complaints in our free online dictionary! Find words starting with complaints and anagrams of complaints. Lookup complaints in the Scrabble Dictionary complaints - 1 definition - noun 1. complaints -- see complaint Source: OWL 2 Web Ontology Language   <<  definition of  complaintive definition of  complaisance  >> Scrabble Dictionary  Collins  Words with Friends  Tournament Word List  SOWPODS Word Finder Points Scrabble 66 Words with Friends 56 Lexulous 70 WordFeud 58 Text Twist 1000 Boggle 8 Words in A Word 10 TOP 20 ANAGRAMS compliant platonics complains complaint platonism salpicon tampions misplant lampions campions coalpits pactions oilcamps monastic postical complain captions maintops ptomains limacons Words Starting With Words that Start with complaints Words that End with complaints Words that Contain complaints

complain From Longman Dictionary of Contemporary English complain com‧plain / kəmˈpleɪn / ●●● S2 W3 verb     1 [ intransitive, transitive ] COMPLAIN to say that you are annoyed , not satisfied , or unhappy about something or someone → complaint   Residents are complaining because traffic in the area has increased.   ‘You never ask my opinion about anything, ’ Rod complained. complain (that)   She complained that no one had been at the airport to meet her. complain about   She often complains about not feeling appreciated at work. complain of   Several women have complained of sexual harassment. complain to   Neighbours complained to the police about the dogs barking.   Employees complained bitterly about working conditions. Grammar You complain about something or someone: They complained about the service. ✗ Don’t say: They complained against the service. | They complained for the service. 2 → (I/you/he etc) can’t complain COLLOCATIONS adverbs complain bitterly (= in a very angry way ) My grandfather’s always complaining bitterly about how expensive things are. complain loudly The kids were complaining loudly about the heat. constantly complain She was constantly complaining about her job. phrases have the right to complain You have the right to complain if you’re not satisfied with the service you’re getting. have (good) reason to complain We felt we had good reason to complain about the food at the hotel. have little/no reason to complain The school is good and parents have little reason to complain. have cause to complain Patients sometimes have cause to complain about the hospital treatment they receive. be in a position to complain (= have a good reason to complain ) If you feel you are bullied at work, you are certainly in a position to complain. be the first to complain (= be quick to complain ) He’s the first to complain if he thinks something is unfair. THESAURUS complain to say that you are annoyed, unhappy, or not satisfied about something or someone Several customers complained about the service they received. ‘I wish you’d stop telling me what to do, ’ she complained. make a complaint to formally complain about something to someone in authority His parents made a complaint to the head teacher. protest to complain about something that you think is wrong , especially publicly Demonstrators were protesting against the war. object to say that you oppose or disapprove of something Local residents have objected to the plan. Some teachers objected to the scheme. grumble to keep complaining in a bad-tempered way about something Rail travellers have been grumbling about the increase in ticket prices. What’s he grumbling about now? moan/whine informal ( also whinge / wɪndʒ / British English informal ) to keep complaining in an annoying way Everyone was moaning about the hotel food. Stop whingeing and get on with your work! kick up/make a fuss to complain or become angry about something, especially something that is not very important The soup wasn’t hot enough, but he didn’t want to make a fuss. He kicked up such a fuss that they were offered another room. → complain of something → See Verb table Examples from the Corpus complain • Many were calling the central office to complain . • We had to remove the advertisement because so many people complained . • But you won't catch me complaining . • He constantly complains about how he's treated at work. • I should have complained about the first case, but I was inexperienced then. • Their neighbours complained about their constant loud music . • Workers who had lost their jobs complained bitterly about the way they had been treated. • Denise complained bitterly after he died . • Once at her new work place she complained bitterly of how her style had been cramped . • Jenny's always complaining that her boss gives her too much work. • The patient complained that she had to void more urine . • If the hotel isn't satisfactory , you should complain to the Tourist Office. • This was a worker who showed up every day, never complained , you know, gave the job his all. complained bitterly • The boys gasped , wheezed and giggled ; the plumper ones complained bitterly . • The social worker complained bitterly about the fact that Mrs X had left the home, and told her off. • He complained bitterly after being surprised by Pat Buchanan in an early primary about a pollster whose predictions had been too optimistic . • Denise complained bitterly after he died. • Once at her new work place she complained bitterly of how her style had been cramped. • He complained bitterly of the small attention that was paid to his ideas in his own country. • Norah complained bitterly that her style had brought the company free publicity worth far more than it cost . • We all complained bitterly when it looked as though Adobe was restricting the development of PostScript and keeping the market to itself.