Citations within the context of their regulations
Review the enforcement history for every citation given out with the Devices sector.
21 CFR 801.50(a) - (a) Stand-alone software that is not distributed in packaged form (e.g., when downloaded from a W...
21 CFR 801.20(a) - (a) In general.
21 CFR 801.45(a) - (a) In general. A device that must bear a unique device identifier (UDI) on its label must also ...
21 CFR 801.40(a) - (a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this...
21 CFR 803.18(e) - (e) If you are a manufacturer, you may maintain MDR event files as part of your complaint file, u...
21 CFR 803.18(a) - (a) If you are a user facility, importer, or manufacturer, you must establish and maintain MDR ev...
21 CFR 803.18(b)(2) - (2) If you are a user facility, importer, or manufacturer, you must permit any authorized FDA emp...
21 CFR 803.18(b)(1)(i) - (i) Information in your possession or references to information related to the adverse event, inc...
21 CFR 803.18(b)(1)(ii) - (ii) Copies of all reports submitted under this part (whether paper or electronic), and of all ot...
21 CFR 803.18(b)(1)(iii) - (iii) Copies of all electronic acknowledgments FDA sends you in response to electronic MDR submis...
21 CFR 803.18(d)(1) - (1) If you are a device distributor, you must establish and maintain device complaint records (fi...
21 CFR 803.18(d)(2) - (2) You must retain copies of the required device incident records for a period of 2 years from t...
21 CFR 803.11 - What form should I use to submit reports of individual adverse events and where do I obtain these...
21 CFR 803.17 - What are the requirements for developing, maintaining, and implementing written MDR procedures th...
21 CFR 803.17(b) - (b) Documentation and recordkeeping requirements for:
21 CFR 803.17(b)(1) - (1) Information that was evaluated to determine if an event was reportable;
21 CFR 803.17(b)(2) - (2) All medical device reports and information submitted to manufacturers and/or us;
21 CFR 803.17(b)(4) - (4) Systems that ensure access to information that facilitates timely followup and inspection by ...
21 CFR 803.17(a)(1) - (1) Timely and effective identification, communication, and evaluation of events that may be subj...
21 CFR 803.17(a)(2) - (2) A standardized review process or procedure for determining when an event meets the criteria f...
21 CFR 803.17(a)(3) - (3) Timely transmission of complete medical device reports to manufacturers or to us, or to both ...
21 CFR 803.32 - If I am a user facility, what information must I submit in my individual adverse event reports?
21 CFR 803.30(a)(1) - (1) Reports of death. You must submit a report to us as soon as practicable but no more than 10 ...
21 CFR 803.30(a)(2) - (2) Reports of serious injury. You must submit a report to the manufacturer of the device no lat...
21 CFR 803.33(a) - (a) You must submit to us an annual report on Form FDA 3419. You must submit an annual report by ...
21 CFR 803.40(a) - (a) Reports of deaths or serious injuries. You must submit a report to us, and a copy of this re...
21 CFR 803.40(b) - (b) Reports of malfunctions. You must submit a report to the manufacturer as soon as practicable...
21 CFR 803.42(e)(1) - (1) An indication that this is an importer report (by marking the importer box on the form);
21 CFR 803.56 - If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and...
21 CFR 803.53(a) - (a) An MDR reportable event necessitates remedial action to prevent an unreasonable risk of subst...
21 CFR 803.52(b)(1) - (1) Identification of adverse event or product problem;
21 CFR 803.52(b)(3) - (3) Date of event;
21 CFR 803.52(b)(4) - (4) Date of this report;
21 CFR 803.52(b)(5) - (5) Description of the event or problem, including a discussion of how the device was involved, n...
21 CFR 803.52(b)(2) - (2) Outcomes attributed to the adverse event (e
21 CFR 803.52(b)(2)(iii) - (iii) An injury or illness that requires intervention to prevent permanent impairment of a body s...
21 CFR 803.52(c)(1) - (1) Brand name;
21 CFR 803.52(c)(10) - (10) Whether the device was available for evaluation, and whether the device was returned to the ...
21 CFR 803.52(c)(3) - (3) Manufacturer name, city, and state;
21 CFR 803.52(c)(4) - (4) Model number, catalog number, serial number, lot number, or other identifying number; expirat...
21 CFR 803.52(e)(1) - (1) Your reporting office's contact name and address and device manufacturing site;
21 CFR 803.52(e)(4) - (4) Date received by you (month, day, year);
21 CFR 803.52(f)(1) - (1) Type of reportable event (death, serious injury, malfunction, etc.);
21 CFR 803.52(f)(6) - (6) Evaluation codes (including event codes, method of evaluation, result, and conclusion codes) ...
21 CFR 803.52(f)(7) - (7) Whether remedial action was taken and the type of action;
21 CFR 803.52(a)(1) - (1) Patient name or other identifier;
21 CFR 803.52(a)(2) - (2) Patient age at the time of event, or date of birth;
21 CFR 803.52(a)(3) - (3) Patient gender; and
21 CFR 803.52(a)(4) - (4) Patient weight.
21 CFR 803.50(b)(1) - (1) You must submit all information required in this subpart E that is reasonably known to you. W...
21 CFR 803.50(b)(2) - (2) You are responsible for obtaining and submitting to us information that is incomplete or miss...
21 CFR 803.50(b)(3) - (3) You are also responsible for conducting an investigation of each event and evaluating the cau...
21 CFR 803.50(a)(1) - (1) May have caused or contributed to a death or serious injury or
21 CFR 803.50(a)(2) - (2) Has malfunctioned and this device or a similar device that you market would be likely to caus...
21 CFR 806.20(a) - (a) Each device manufacturer or importer who initiates a correction or removal of a device that i...
21 CFR 806.20(b)(1) - (1) The brand name, common or usual name, classification, name and product code if known, and the...
21 CFR 806.20(b)(2) - (2) The unique device identifier (UDI) of the device, or the device identifier, universal product...
21 CFR 806.20(b)(3) - (3) A description of the event(s) giving rise to the information reported and the corrective or r...
21 CFR 806.20(b)(4) - (4) Justification for not reporting the correction or removal action to FDA, which shall contain ...
21 CFR 806.20(b)(5) - (5) A copy of all communications regarding the correction or removal.
21 CFR 806.10(d) - (d) If, after submitting a report under this part, a manufacturer or importer determines that the...
21 CFR 806.10(b) - (b) The manufacturer or importer shall submit any report required by paragraph (a) of this sectio...
21 CFR 806.10(c)(10) - (10) The date of manufacture or distribution and the device's expiration date or expected life.
21 CFR 806.10(c)(11) - (11) The names, addresses, and telephone numbers of all domestic and foreign consignees of the de...
21 CFR 806.10(c)(4) - (4) Marketing status of the device, i.e., any applicable premarket notification number, premarket...
21 CFR 806.10(c)(7) - (7) A description of the event(s) giving rise to the information reported and the corrective or r...
21 CFR 806.10(c)(8) - (8) Any illness or injuries that have occurred with use of the device. If applicable, include the...
21 CFR 806.10(c)(9) - (9) The total number of devices manufactured or distributed subject to the correction or removal ...
21 CFR 806.10(a)(1) - (1) To reduce a risk to health posed by the device; or
21 CFR 806.10(a)(2) - (2) To remedy a violation of the act caused by the device which may present a risk to health unle...
21 CFR 806.30 - FDA access to records.
21 CFR 807.20(a) - (a) An owner or operator of an establishment not exempt under section 510(g) of the Federal Food,...
21 CFR 807.22(a) - (a) Initial registration and listing. An owner or operator of an establishment who has not previ...
21 CFR 807.22(b)(1) - (1) Annual registration for each fiscal year is required for all establishments. Annual registrat...
21 CFR 807.22(b)(3) - (3) Every fiscal year, during the period beginning on October 1 and ending on December 31, owners...
21 CFR 809.10(c)(2)(ii) - (ii) For a product being shipped or delivered for product testing prior to full commercial market...
21 CFR 809.10(a)(2) - (2) The intended use or uses of the product.
21 CFR 809.10(a)(5) - (5) For a reagent, appropriate storage instructions adequate to protect the stability of the prod...
21 CFR 809.10(a)(9)(i) - (i) If it is a multiple unit product, the lot or control number shall permit tracing the identity...
21 CFR 809.10(b)(10) - (10) Limitation of the procedure: Include a statement of limitations of the procedure. State know...
21 CFR 809.10(b)(5)(iv) - (iv) Appropriate storage instructions adequate to protect the stability of the product. When appl...
21 CFR 809.20(b) - (b) Compliance with good manufacturing practices. In vitro diagnostic products shall be manufact...
21 CFR 812.7(a) - (a) Promote or test market an investigational device, until after FDA has approved the device for...
21 CFR 812.7(d) - (d) Represent that an investigational device is safe or effective for the purposes for which it i...
21 CFR 812.7(b) - (b) Commercialize an investigational device by charging the subjects or investigators for a devic...
21 CFR 812.5(a) - (a) Contents. An investigational device or its immediate package shall bear a label with the fol...
21 CFR 812.18(b) - (b) Exports. A person exporting an investigational device subject to this part shall obtain FDA'...
21 CFR 812.2(b) - (b) Abbreviated requirements. The following categories of investigations are considered to have ...
21 CFR 812.2(c) - (c) Exempted investigations
21 CFR 812.2(c)(3) - (3) A diagnostic device, if the sponsor complies with applicable requirements in § 809.10(c) and ...
21 CFR 812.2(c)(7) - (7) A custom device as defined in § 812.3(b), unless the device is being used to determine safety...
21 CFR 812.20(a)(1) - (1) A sponsor shall submit an application to FDA if the sponsor intends to use a significant risk...
21 CFR 812.20(a)(2) - (2) A sponsor shall not begin an investigation for which FDA's approval of an application is requ...
21 CFR 812.36(e) - (e) Safeguards. Treatment use of an investigational device is conditioned upon the sponsor and i...
21 CFR 812.36(d) - (d) FDA action on treatment IDE applications —
21 CFR 812.35(a)(1) - (1) Changes requiring prior approval. Except as described in paragraphs (a)(2) through (a)(4) of...
21 CFR 812.35(a)(3)(iv) - (iv) Notice of IDE change. Changes meeting the criteria in paragraphs (a)(3)(i) and (a)(3)(ii) o...
21 CFR 812.25(e) - (e) Monitoring procedures. The sponsor's written procedures for monitoring the investigation and...
21 CFR 812.40 - General responsibilities of sponsors.
21 CFR 812.42 - FDA and IRB approval.
21 CFR 812.43(a) - (a) Selecting investigators. A sponsor shall select investigators qualified by training and expe...
21 CFR 812.43(b) - (b) Control of device. A sponsor shall ship investigational devices only to qualified investigat...
21 CFR 812.43(d) - (d) Selecting monitors. A sponsor shall select monitors qualified by training and experience to ...
21 CFR 812.43(c) - (c) Obtaining agreements
21 CFR 812.43(c)(1) - (1) The investigator's curriculum vitae.
21 CFR 812.43(c)(2) - (2) Where applicable, a statement of the investigator's relevant experience, including the dates,...
21 CFR 812.43(c)(3) - (3) If the investigator was involved in an investigation or other research that was terminated, a...
21 CFR 812.43(c)(5) - (5) Sufficient accurate financial disclosure information to allow the sponsor to submit a complet...
21 CFR 812.43(c)(4)(i) - (i) Conduct the investigation in accordance with the agreement, the investigational plan, this pa...
21 CFR 812.43(c)(4)(ii) - (ii) Supervise all testing of the device involving human subjects; and
21 CFR 812.43(c)(4)(iii) - (iii) Ensure that the requirements for obtaining informed consent are met.
21 CFR 812.46(c) - (c) Resumption of terminated studies. If the device is a significant risk device, a sponsor may ...
21 CFR 812.46(a) - (a) Securing compliance. A sponsor who discovers that an investigator is not complying with the ...
21 CFR 812.46(b)(1) - (1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect.
21 CFR 812.45 - Informing investigators.
21 CFR 812.66 - Significant risk device determinations.
21 CFR 812.100 - General responsibilities of investigators.
21 CFR 812.110(a) - (a) Awaiting approval. An investigator may determine whether potential subjects would be interes...
21 CFR 812.110(c) - (c) Supervising device use. An investigator shall permit an investigational device to be used on...
21 CFR 812.110(d) - (d) Financial disclosure. A clinical investigator shall disclose to the sponsor sufficient accur...
21 CFR 812.110(b) - (b) Compliance. An investigator shall conduct an investigation in accordance with the signed agr...
21 CFR 812.150(a)(1) - (1) Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the...
21 CFR 812.150(a)(2) - (2) Withdrawal of IRB approval. An investigator shall report to the sponsor, within 5 working da...
21 CFR 812.150(a)(3) - (3) Progress. An investigator shall submit progress reports on the investigation to the sponsor,...
21 CFR 812.150(a)(4) - (4) Deviations from the investigational plan. An investigator shall notify the sponsor and the r...
21 CFR 812.150(a)(5) - (5) Informed consent. If an investigator uses a device without obtaining informed consent, the i...
21 CFR 812.150(a)(6) - (6) Final report. An investigator shall, within 3 months after termination or completion of the ...
21 CFR 812.150(a)(7) - (7) Other. An investigator shall, upon request by a reviewing IRB or FDA, provide accurate, comp...
21 CFR 812.150(b)(1) - (1) Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipat...
21 CFR 812.150(b)(10) - (10) Other. A sponsor shall, upon request by a reviewing IRB or FDA, provide accurate, complete,...
21 CFR 812.150(b)(2) - (2) Withdrawal of IRB approval. A sponsor shall notify FDA and all reviewing IRB's and participa...
21 CFR 812.150(b)(3) - (3) Withdrawal of FDA approval. A sponsor shall notify all reviewing IRB's and participating inv...
21 CFR 812.150(b)(4) - (4) Current investigator list. A sponsor shall submit to FDA, at 6-month intervals, a current li...
21 CFR 812.150(b)(5) - (5) Progress reports. At regular intervals, and at least yearly, a sponsor shall submit progress...
21 CFR 812.150(b)(6) - (6) Recall and device disposition. A sponsor shall notify FDA and all reviewing IRB's of any req...
21 CFR 812.150(b)(7) - (7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within ...
21 CFR 812.150(b)(8) - (8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator unde...
21 CFR 812.140(e) - (e) Records custody. An investigator or sponsor may withdraw from the responsibility to maintain...
21 CFR 812.140(d) - (d) Retention period. An investigator or sponsor shall maintain the records required by this sub...
21 CFR 812.140(a)(1) - (1) All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, includi...
21 CFR 812.140(a)(4) - (4) The protocol, with documents showing the dates of and reasons for each deviation from the pro...
21 CFR 812.140(a)(5) - (5) Any other records that FDA requires to be maintained by regulation or by specific requirement...
21 CFR 812.140(a)(2)(i) - (i) The type and quantity of the device, the dates of its receipt, and the batch number or code m...
21 CFR 812.140(a)(2)(ii) - (ii) The names of all persons who received, used, or disposed of each device.
21 CFR 812.140(a)(2)(iii) - (iii) Why and how many units of the device have been returned to the sponsor, repaired, or otherw...
21 CFR 812.140(a)(3) - (3) Records of each subject's case history and exposure to the device
21 CFR 812.140(a)(3)(i) - (i) Documents evidencing informed consent and, for any use of a device by the investigator withou...
21 CFR 812.140(a)(3)(ii) - (ii) All relevant observations, including records concerning adverse device effects (whether anti...
21 CFR 812.140(a)(3)(iii) - (iii) A record of the exposure of each subject to the investigational device, including the date ...
21 CFR 812.140(b)(1) - (1) All correspondence with another sponsor, a monitor, an investigator, an IRB, or FDA, includin...
21 CFR 812.140(b)(2) - (2) Records of shipment and disposition. Records of shipment shall include the name and address o...
21 CFR 812.140(b)(3) - (3) Signed investigator agreements including the financial disclosure information required to be ...
21 CFR 812.140(b)(5) - (5) Records concerning adverse device effects (whether anticipated or unanticipated) and complain...
21 CFR 812.140(b)(6) - (6) Any other records that FDA requires to be maintained by regulation or by specific requirement...
21 CFR 812.140(b)(4) - (4) For each investigation subject to § 812
21 CFR 812.140(b)(4)(i) - (i) The name and intended use of the device and the objectives of the investigation;
21 CFR 812.140(b)(4)(ii) - (ii) A brief explanation of why the device is not a significant risk device:
21 CFR 812.140(b)(4)(iv) - (iv) The name and address of each IRB that has reviewed the investigation:
21 CFR 812.140(b)(4)(v) - (v) A statement of the extent to which the good manufacturing practice regulation in part 820 wil...
21 CFR 812.140(b)(4)(vi) - (vi) Any other information required by FDA.
21 CFR 820.25(a) - (a) General. Each manufacturer shall have sufficient personnel with the necessary education, bac...
21 CFR 820.25(b) - (b) Training
21 CFR 820.25(b)(2) - (2) Personnel who perform verification and validation activities shall be made aware of defects a...
21 CFR 820.20(e) - (e) Quality system procedures. Each manufacturer shall establish quality system procedures and i...
21 CFR 820.20(c) - (c) Management review. Management with executive responsibility shall review the suitability and...
21 CFR 820.20(d) - (d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality...
21 CFR 820.20(a) - (a) Quality policy. Management with executive responsibility shall establish its policy and obje...
21 CFR 820.20 - Management responsibility.
21 CFR 820.20(b) - (b) Organization
21 CFR 820.20(b)(1) - (1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibili...
21 CFR 820.20(b)(2) - (2) Resources. Each manufacturer shall provide adequate resources, including the assignment of t...
21 CFR 820.20(b)(3) - (3) Management representative
21 CFR 820.20(b)(3)(i) - (i) Ensuring that quality system requirements are effectively established and effectively maintai...
21 CFR 820.20(b)(3)(ii) - (ii) Reporting on the performance of the quality system to management with executive responsibili...
21 CFR 820.22 - Quality audit.
21 CFR 820.30(d) - (d) Design output. Each manufacturer shall establish and maintain procedures for defining and do...
21 CFR 820.30(e) - (e) Design review. Each manufacturer shall establish and maintain procedures to ensure that form...
21 CFR 820.30(a) - (a) General.
21 CFR 820.30(f) - (f) Design verification. Each manufacturer shall establish and maintain procedures for verifying...
21 CFR 820.30(i) - (i) Design changes. Each manufacturer shall establish and maintain procedures for the identifica...
21 CFR 820.30(h) - (h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that th...
21 CFR 820.30(b) - (b) Design and development planning. Each manufacturer shall establish and maintain plans that d...
21 CFR 820.30(c) - (c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the d...
21 CFR 820.30(g) - (g) Design validation. Each manufacturer shall establish and maintain procedures for validating ...
21 CFR 820.30(j) - (j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of d...
21 CFR 820.40(a) - (a) Document approval and distribution. Each manufacturer shall designate an individual(s) to re...
21 CFR 820.40(b) - (b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in...
21 CFR 820.40 - Document controls.
21 CFR 820.50(b) - (b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe o...
21 CFR 820.50 - Purchasing controls.
21 CFR 820.50(a) - (a) Evaluation of suppliers, contractors, and consultants
21 CFR 820.50(a)(1) - (1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their a...
21 CFR 820.50(a)(2) - (2) Define the type and extent of control to be exercised over the product, services, suppliers, ...
21 CFR 820.50(a)(3) - (3) Establish and maintain records of acceptable suppliers, contractors, and consultants.
21 CFR 820.60 - Identification.
21 CFR 820.65 - Traceability.
21 CFR 820.75(a) - (a) Where the results of a process cannot be fully verified by subsequent inspection and test, th...
21 CFR 820.75(c) - (c) When changes or process deviations occur, the manufacturer shall review and evaluate the proc...
21 CFR 820.75(b) - (b) Each manufacturer shall establish and maintain procedures for monitoring and control of proce...
21 CFR 820.75(b)(1) - (1) Each manufacturer shall ensure that validated processes are performed by qualified individual...
21 CFR 820.75(b)(2) - (2) For validated processes, the monitoring and control methods and data, the date performed, and...
21 CFR 820.72(a) - (a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that al...
21 CFR 820.72(b) - (b) Calibration
21 CFR 820.72(b)(1) - (1) Calibration standards. Calibration standards used for inspection, measuring, and test equipm...
21 CFR 820.72(b)(2) - (2) Calibration records. The equipment identification, calibration dates, the individual perform...
21 CFR 820.70(h) - (h) Manufacturing material. Where a manufacturing material could reasonably be expected to have ...
21 CFR 820.70(c) - (c) Environmental control. Where environmental conditions could reasonably be expected to have a...
21 CFR 820.70(e) - (e) Contamination control. Each manufacturer shall establish and maintain procedures to prevent ...
21 CFR 820.70(i) - (i) Automated processes. When computers or automated data processing systems are used as part of...
21 CFR 820.70(b) - (b) Production and process changes. Each manufacturer shall establish and maintain procedures fo...
21 CFR 820.70(d) - (d) Personnel. Each manufacturer shall establish and maintain requirements for the health, clean...
21 CFR 820.70(f) - (f) Buildings. Buildings shall be of suitable design and contain sufficient space to perform nec...
21 CFR 820.70(g) - (g) Equipment
21 CFR 820.70(g)(1) - (1) Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjus...
21 CFR 820.70(g)(2) - (2) Inspection. Each manufacturer shall conduct periodic inspections in accordance with establis...
21 CFR 820.70(g)(3) - (3) Adjustment. Each manufacturer shall ensure that any inherent limitations or allowable tolera...
21 CFR 820.70(a) - (a) General
21 CFR 820.70(a)(1) - (1) Documented instructions, standard operating procedures (SOP's), and methods that define and c...
21 CFR 820.70(a)(2) - (2) Monitoring and control of process parameters and component and device characteristics during ...
21 CFR 820.70(a)(3) - (3) Compliance with specified reference standards or codes;
21 CFR 820.70(a)(4) - (4) The approval of processes and process equipment; and
21 CFR 820.70(a)(5) - (5) Criteria for workmanship which shall be expressed in documented standards or by means of iden...
21 CFR 820.86 - Acceptance status.
21 CFR 820.80(a) - (a) General. Each manufacturer shall establish and maintain procedures for acceptance activities...
21 CFR 820.80(c) - (c) In-process acceptance activities. Each manufacturer shall establish and maintain acceptance ...
21 CFR 820.80(b) - (b) Receiving acceptance activities. Each manufacturer shall establish and maintain procedures f...
21 CFR 820.80(e) - (e) Acceptance records
21 CFR 820.80(e)(1) - (1) The acceptance activities performed;
21 CFR 820.80(e)(3) - (3) the results;
21 CFR 820.80(e)(4) - (4) the signature of the individual(s) conducting the acceptance activities; and
21 CFR 820.80(e)(5) - (5) where appropriate the equipment used. These records shall be part of the DHR.
21 CFR 820.80(d) - (d) Final acceptance activities
21 CFR 820.80(d)(1) - (1) The activities required in the DMR are completed;
21 CFR 820.80(d)(2) - (2) the associated data and documentation is reviewed;
21 CFR 820.80(d)(3) - (3) the release is authorized by the signature of a designated individual(s); and
21 CFR 820.80(d)(4) - (4) the authorization is dated.
21 CFR 820.90(a) - (a) Control of nonconforming product. Each manufacturer shall establish and maintain procedures ...
21 CFR 820.90(b)(1) - (1) Each manufacturer shall establish and maintain procedures that define the responsibility for ...
21 CFR 820.90(b)(2) - (2) Each manufacturer shall establish and maintain procedures for rework, to include retesting an...
21 CFR 820.100(b) - (b) All activities required under this section, and their results, shall be documented.
21 CFR 820.100(a) - (a) Each manufacturer shall establish and maintain procedures for implementing corrective and pre...
21 CFR 820.100(a)(1) - (1) Analyzing processes, work operations, concessions, quality audit reports, quality records, se...
21 CFR 820.100(a)(2) - (2) Investigating the cause of nonconformities relating to product, processes, and the quality sy...
21 CFR 820.100(a)(3) - (3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product a...
21 CFR 820.100(a)(4) - (4) Verifying or validating the corrective and preventive action to ensure that such action is ef...
21 CFR 820.100(a)(5) - (5) Implementing and recording changes in methods and procedures needed to correct and prevent id...
21 CFR 820.100(a)(6) - (6) Ensuring that information related to quality problems or nonconforming product is disseminate...
21 CFR 820.100(a)(7) - (7) Submitting relevant information on identified quality problems, as well as corrective and pre...
21 CFR 820.130 - Device packaging.
21 CFR 820.120(d) - (d) Labeling operations. Each manufacturer shall control labeling and packaging operations to pr...
21 CFR 820.120(c) - (c) Labeling storage. Each manufacturer shall store labeling in a manner that provides proper id...
21 CFR 820.120(b) - (b) Labeling inspection. Labeling shall not be released for storage or use until a designated in...
21 CFR 820.120(a) - (a) Label integrity. Labels shall be printed and applied so as to remain legible and affixed dur...
21 CFR 820.120(e) - (e) Control number. Where a control number is required by § 820.65, that control number shall be...
21 CFR 820.120 - Device labeling.
21 CFR 820.160(a) - (a) Each manufacturer shall establish and maintain procedures for control and distribution of fin...
21 CFR 820.160(b) - (b) Each manufacturer shall maintain distribution records which include or refer to the location ...
21 CFR 820.170(a) - (a) Each manufacturer of a device requiring installation shall establish and maintain adequate in...
21 CFR 820.170(b) - (b) The person installing the device shall ensure that the installation, inspection, and any requ...
21 CFR 820.150(b) - (b) Each manufacturer shall establish and maintain procedures that describe the methods for autho...
21 CFR 820.150(a) - (a) Each manufacturer shall establish and maintain procedures for the control of storage areas an...
21 CFR 820.150 - Storage.
21 CFR 820.140 - Handling.
21 CFR 820.184(d) - (d) The acceptance records which demonstrate the device is manufactured in accordance with the DM...
21 CFR 820.184(e) - (e) The primary identification label and labeling used for each production unit; and
21 CFR 820.184(b) - (b) The quantity manufactured;
21 CFR 820.184(a) - (a) The dates of manufacture;
21 CFR 820.184(f) - (f) Any unique device identifier (UDI) or universal product code (UPC), and any other device iden...
21 CFR 820.184(c) - (c) The quantity released for distribution;
21 CFR 820.184 - Device history record.
21 CFR 820.180(b) - (b) Record retention period. All records required by this part shall be retained for a period of...
21 CFR 820.180 - General requirements.
21 CFR 820.186 - Quality system record.
21 CFR 820.181(c) - (c) Quality assurance procedures and specifications including acceptance criteria and the quality...
21 CFR 820.181(b) - (b) Production process specifications including the appropriate equipment specifications, product...
21 CFR 820.181(d) - (d) Packaging and labeling specifications, including methods and processes used; and
21 CFR 820.181(a) - (a) Device specifications including appropriate drawings, composition, formulation, component spe...
21 CFR 820.181 - Device master record.
21 CFR 820.198(f) - (f) When the manufacturer's formally designated complaint unit is located at a site separate from...
21 CFR 820.198(g) - (g) If a manufacturer's formally designated complaint unit is located outside of the United State...
21 CFR 820.198(b) - (b) Each manufacturer shall review and evaluate all complaints to determine whether an investigat...
21 CFR 820.198(c) - (c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any ...
21 CFR 820.198(d) - (d) Any complaint that represents an event which must be reported to FDA under part 803 of this c...
21 CFR 820.198(d)(3) - (3) The relationship, if any, of the device to the reported incident or adverse event.
21 CFR 820.198(a) - (a) Each manufacturer shall maintain complaint files
21 CFR 820.198(a)(1) - (1) All complaints are processed in a uniform and timely manner;
21 CFR 820.198(a)(2) - (2) Oral complaints are documented upon receipt; and
21 CFR 820.198(a)(3) - (3) Complaints are evaluated to determine whether the complaint represents an event which is requ...
21 CFR 820.198(e) - (e) When an investigation is made under this section, a record of the investigation shall be main...
21 CFR 820.198(e)(2) - (2) The date the complaint was received;
21 CFR 820.198(e)(3) - (3) Any unique device identifier (UDI) or universal product code (UPC), and any other device iden...
21 CFR 820.198(e)(4) - (4) The name, address, and phone number of the complainant;
21 CFR 820.198(e)(5) - (5) The nature and details of the complaint;
21 CFR 820.198(e)(6) - (6) The dates and results of the investigation;
21 CFR 820.198(e)(7) - (7) Any corrective action taken; and
21 CFR 820.198(e)(8) - (8) Any reply to the complainant.
21 CFR 820.200(c) - (c) Each manufacturer who receives a service report that represents an event which must be report...
21 CFR 820.200(b) - (b) Each manufacturer shall analyze service reports with appropriate statistical methodology in a...
21 CFR 820.200(a) - (a) Where servicing is a specified requirement, each manufacturer shall establish and maintain in...
21 CFR 820.200(d) - (d) Service reports shall be documented and shall include:
21 CFR 820.200(d)(3) - (3) The date of service;
21 CFR 820.200(d)(4) - (4) The individual(s) servicing the device;
21 CFR 820.200(d)(5) - (5) The service performed; and
21 CFR 820.200(d)(6) - (6) The test and inspection data.
21 CFR 820.250(b) - (b) Sampling plans, when used, shall be written and based on a valid statistical rationale. Each ...
21 CFR 820.250(a) - (a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying ...
21 CFR 821.25(b) - (b) A manufacturer of a tracked device shall keep current records in accordance with its standard...
21 CFR 821.25(a) - (a) A manufacturer of a tracked device shall adopt a method of tracking for each such type of dev...
21 CFR 821.25(d) - (d) When a manufacturer becomes aware that a distributor, final distributor, or multiple distribu...
21 CFR 821.25(c) - (c) A manufacturer of a tracked device shall establish a written standard operating procedure for...
21 CFR 821.25(c)(1) - (1) Data collection and recording procedures, which shall include a procedure for recording when ...
21 CFR 821.25(c)(3) - (3) A quality assurance program that includes an audit procedure to be run for each device produc...
21 CFR 821.20(a) - (a) A manufacturer of any class II or class III device that fits within one of the three criteria...
21 CFR 821.30(a) - (a) A distributor, final distributor, or multiple distributor of any tracked device shall, upon p...
21 CFR 821.50(a) - (a) Manufacturers, distributors, multiple distributors, and final distributors shall, upon the pr...
21 CFR 830.300(a) - (a) In general. The labeler of a device must provide the information required by this subpart fo...
21 CFR 830.310(b) - (b) Concerning each version or model of a device with a UDI on its label:
21 CFR 860.7(g)(1) - (1) It is the responsibility of each manufacturer and importer of a device to assure that adequat...
21 CFR 860.7(g)(2) - (2) The Commissioner may require that a manufacturer, importer, or distributor make reports or pr...