language: Deutsch   Français   italiano   Español   Português   日本語   russian   arabic   norwegian   swedish   danish   Nederlands   finland   ireland   English  

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]

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 ruvrtjxf. moncler mente 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

discount moncler jackets uk
outlet moncler milano
moncler outlet italya
moncler monaco sneaker
moncler sale womens jackets 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: 21CFR820.198]

DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 820 -- QUALITY SYSTEM REGULATION Subpart M--Records Sec. 820.198 Complaint files. (a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that: (1) All complaints are processed in a uniform and timely manner; (2) Oral complaints are documented upon receipt; and (3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting. (b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate. (c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary. (d) Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by 820.198(e), records of investigation under this paragraph shall include a determination of: (1) Whether the device failed to meet specifications; (2) Whether the device was being used for treatment or diagnosis; and (3) The relationship, if any, of the device to the reported incident or adverse event. (e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include: (1) The name of the device; (2) The date the complaint was received; (3) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used; (4) The name, address, and phone number of the complainant; (5) The nature and details of the complaint; (6) The dates and results of the investigation; (7) Any corrective action taken; and (8) Any reply to the complainant. (f) When the manufacturer's formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment. (g) If a manufacturer's formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either: (1) A location in the United States where the manufacturer's records are regularly kept; or (2) The location of the initial distributor. -


A grievance is any complaint or dispute (other than an organization determination) expressing dissatisfaction with any aspect of the operations, activities, or behavior of a Medicare health plan, or its providers, regardless of whether remedial action is requested. 

The enrollee must file the grievance either orally or in writing no later than 60 days after the triggering event or incident precipitating the grievance.

Listed below are some examples of problems that are typically dealt with through the plan grievance process:

Problems getting an appointment, or having to wait a long time for an appointment Disrespectful or rude behavior by doctors, nurses or other plan clinic or hospital staff

Each plan must provide meaningful procedures for timely hearing and resolving both standard and expedited grievances between enrollees and the Medicare health plan or any other entity or individual through which the Medicare health plan provides health care services. 

The Medicare health plan must include in its grievance procedures:

 The ability to accept any information or evidence concerning the grievance orally or in writing not later than 60 days after the event; and   The requirement to respond within 24 hours to an enrollee's expedited grievance whenever:  A Medicare health plan extends the time frame to make an organization determination or reconsideration; or    A Medicare health plan refuses to grant a request for an expedited organization determination or reconsideration.

Plans must notify all concerned parties upon completion of the investigation as expeditiously as the enrollee's case requires based on the enrollee's health status, but not later than 30 days after the grievance is received.

Quality of care grievances (complaints about the quality of care received in hospital or other provider settings) may be reported through the plan's grievance procedures, the enrollee's Beneficiary Family Centered Care - Quality Improvement Organization (BFCC-QIO), or both. 

For more information about the grievance process, see section 20.3 in Chapter 13 of the Medicare Managed Care Manual. A copy of the model notice plans may use to notify enrollees about their right to an expedited grievance is located in Appendix 6 of Chapter 13, in the “Downloads” section below, or found under “Notices and Forms” using the link on the left navigation menu on this page.  

Grievances related to Part D prescription drug benefits or services received through a plan are not processed using these procedures. For information on how to file a grievance related to Part D prescription drug benefits or services, click on the link to Chapter 18 of the Prescription Drug Benefit Manual under the "Downloads" section below.

For more information about filing a grievance with the BFCC-QIO, click on the link to the Medicare publication “Medicare Rights and Protections” under the "Related Links" section below.