specified reference standards.
The results of the design verification, including identification of the design, method(s part the date, and the individual(s) performing the verification, shall be documented in the DHF.(g) Design validation.
Subpart N-Servicing 820.200 Servicing.
(1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f 2) of the act.
1271.3(d) of this chapter, that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions part of the act or under a part biological product license application under section 351 of the Public Health Service Act).Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part.Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part.Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent part mixups.(d) Labeling part operations.Subpart D-Document Controls 820.40 Document controls.
(1) Current good manufacturing practice (cgmp) requirements are set forth in part this quality system regulation.
Subpart A -General Provisions 820.1 Scope.
The requirements in this part are intended to ensure part that finished devices will be safe and part effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).Changes shall be approved part in accordance with 820.40.(c) Environmental control.216, 262, 263a, urce: 61 FR 52654, Oct.Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed.(e) When an investigation is part made under this section, a record of the investigation shall be maintained by the formally designated unit part identified in paragraph (a) of this section.The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed.(a) Control of nonconforming product.Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results.(b) Each yurina manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary.(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications.Documentation part shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use.
(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.
(1) As part of their 21 cfr part 820 pdf training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.
A requirement is appropriate' if nonimplementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.