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Warning Letters
Review Warning Letters by infraction
Regulations
Part 801: Labeling
Subpart B: Labeling Requirements for Unique Device Identification
21 CFR 801.20 - Label to bear a unique device identifier.
21 CFR 801.20(a) - (a) In general.
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Part 803: Medical Device Reporting
Subpart A: General Provisions
21 CFR 803.18 - What are the requirements for establishing and maintaining MDR files or records that apply to me?
21 CFR 803.18(b) - (b)
21 CFR 803.18(b)(1) - (1) For purposes of this part, “MDR event files” are written or electronic files maintained by us...
21 CFR 803.18(b)(1)(i) - (i) Information in your possession or references to information related to the adverse event, inc...
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21 CFR 803.18(b)(1)(iii) - (iii) Copies of all electronic acknowledgments FDA sends you in response to electronic MDR submis...
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21 CFR 803.11 - What form should I use to submit reports of individual adverse events and where do I obtain these...
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21 CFR 803.17 - What are the requirements for developing, maintaining, and implementing written MDR procedures th...
21 CFR 803.17 - What are the requirements for developing, maintaining, and implementing written MDR procedures th...
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21 CFR 803.17(a) - (a) Internal systems that provide for:
21 CFR 803.17(a) - (a) Internal systems that provide for:
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21 CFR 803.17(a)(1) - (1) Timely and effective identification, communication, and evaluation of events that may be subj...
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21 CFR 803.17(a)(2) - (2) A standardized review process or procedure for determining when an event meets the criteria f...
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21 CFR 803.17(a)(3) - (3) Timely transmission of complete medical device reports to manufacturers or to us, or to both ...
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21 CFR 803.17(b) - (b) Documentation and recordkeeping requirements for:
21 CFR 803.17(b) - (b) Documentation and recordkeeping requirements for:
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21 CFR 803.17(b)(1) - (1) Information that was evaluated to determine if an event was reportable;
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Subpart D: Importer Reporting Requirements
21 CFR 803.42 - If I am an importer, what information must I submit in my individual adverse event reports?
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21 CFR 803.40 - If I am an importer, what reporting requirements apply to me?
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Subpart E: Manufacturer Reporting Requirements
21 CFR 803.56 - If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and...
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21 CFR 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?
21 CFR 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?
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21 CFR 803.52(b) - (b) Adverse event or product problem (Form FDA 3500A, Block B). You must submit the following:
21 CFR 803.52(b)(2) - (2) Outcomes attributed to the adverse event (e
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21 CFR 803.52(b)(3) - (3) Date of event;
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21 CFR 803.52(e) - (e) Reporting information for all manufacturers (Form FDA 3500A, Block G). You must submit the fo...
21 CFR 803.52(e)(4) - (4) Date received by you (month, day, year);
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21 CFR 803.50 - If I am a manufacturer, what reporting requirements apply to me?
21 CFR 803.50 - If I am a manufacturer, what reporting requirements apply to me?
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21 CFR 803.50(b) - (b) What information does FDA consider “reasonably known” to me?
21 CFR 803.50(b) - (b) What information does FDA consider “reasonably known” to me?
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21 CFR 803.50(b)(1) - (1) You must submit all information required in this subpart E that is reasonably known to you. W...
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21 CFR 803.50(b)(2) - (2) You are responsible for obtaining and submitting to us information that is incomplete or miss...
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21 CFR 803.50(b)(3) - (3) You are also responsible for conducting an investigation of each event and evaluating the cau...
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21 CFR 803.50(a) - (a) If you are a manufacturer, you must report to us the information required by § 803.52 in acco...
21 CFR 803.50(a) - (a) If you are a manufacturer, you must report to us the information required by § 803.52 in acco...
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21 CFR 803.50(a)(1) - (1) May have caused or contributed to a death or serious injury or
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21 CFR 803.50(a)(2) - (2) Has malfunctioned and this device or a similar device that you market would be likely to caus...
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21 CFR 803.53 - If I am a manufacturer, in which circumstances must I submit a 5-day report?
21 CFR 803.53(a) - (a) An MDR reportable event necessitates remedial action to prevent an unreasonable risk of subst...
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21 CFR 803.53 - If I am a manufacturer, in which circumstances must I submit a 5-day report?
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Part 806: Medical Devices; Reports of Corrections and Removals
Subpart B: Reports and Records
21 CFR 806.20 - Records of corrections and removals not required to be reported.
21 CFR 806.20 - Records of corrections and removals not required to be reported.
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21 CFR 806.20(b) - (b) Records of corrections and removals not required to be reported to FDA under § 806.10 shall c...
21 CFR 806.20(b)(4) - (4) Justification for not reporting the correction or removal action to FDA, which shall contain ...
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21 CFR 806.20(b)(5) - (5) A copy of all communications regarding the correction or removal.
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21 CFR 806.10 - Reports of corrections and removals.
21 CFR 806.10(b) - (b) The manufacturer or importer shall submit any report required by paragraph (a) of this sectio...
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21 CFR 806.10 - Reports of corrections and removals.
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21 CFR 806.10(a) - (a) Each device manufacturer or importer shall submit a written report to FDA of any correction o...
21 CFR 806.10(a) - (a) Each device manufacturer or importer shall submit a written report to FDA of any correction o...
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21 CFR 806.10(a)(1) - (1) To reduce a risk to health posed by the device; or
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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...
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Part 807: Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Subpart B: Procedures for Device Establishments
21 CFR 807.22 - Times for establishment registration and device listing.
21 CFR 807.22(b) - (b) Registration and listing updates. Owners or operators shall review and update all of their e...
21 CFR 807.22(b)(3) - (3) Every fiscal year, during the period beginning on October 1 and ending on December 31, owners...
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21 CFR 807.20 - Who must register and submit a device list?
21 CFR 807.20(a) - (a) An owner or operator of an establishment not exempt under section 510(g) of the Federal Food,...
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Part 809: In Vitro Diagnostic Products for Human Use
Subpart B: Labeling
21 CFR 809.10 - Labeling for in vitro diagnostic products.
21 CFR 809.10(c) - (c) A shipment or other delivery of an in vitro diagnostic product shall be exempt from the requi...
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Part 812: Investigational Device Exemptions
Subpart A: General Provisions
21 CFR 812.2 - Applicability.
21 CFR 812.2(b) - (b) Abbreviated requirements. The following categories of investigations are considered to have ...
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21 CFR 812.7 - Prohibition of promotion and other practices.
21 CFR 812.7(a) - (a) Promote or test market an investigational device, until after FDA has approved the device for...
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Subpart B: Application and Administrative Action
21 CFR 812.20 - Application.
21 CFR 812.20(a) - (a) Submission.
21 CFR 812.20(a) - (a) Submission.
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21 CFR 812.20(a)(1) - (1) A sponsor shall submit an application to FDA if the sponsor intends to use a significant risk...
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Subpart C: Responsibilities of Sponsors
21 CFR 812.42 - FDA and IRB approval.
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21 CFR 812.46 - Monitoring investigations.
21 CFR 812.46(a) - (a) Securing compliance. A sponsor who discovers that an investigator is not complying with the ...
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21 CFR 812.46 - Monitoring investigations.
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21 CFR 812.43 - Selecting investigators and monitors.
21 CFR 812.43(c) - (c) Obtaining agreements
21 CFR 812.43(c)(5) - (5) Sufficient accurate financial disclosure information to allow the sponsor to submit a complet...
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21 CFR 812.43(c)(4) - (4) A statement of the investigator's commitment to:
21 CFR 812.43(c)(4)(i) - (i) Conduct the investigation in accordance with the agreement, the investigational plan, this pa...
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21 CFR 812.40 - General responsibilities of sponsors.
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Subpart E: Responsibilities of Investigators
21 CFR 812.100 - General responsibilities of investigators.
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21 CFR 812.110 - Specific responsibilities of investigators.
21 CFR 812.110(a) - (a) Awaiting approval. An investigator may determine whether potential subjects would be interes...
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21 CFR 812.110(b) - (b) Compliance. An investigator shall conduct an investigation in accordance with the signed agr...
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Subpart G: Records and Reports
21 CFR 812.150 - Reports.
21 CFR 812.150(a) - (a) Investigator reports. An investigator shall prepare and submit the following complete, accur...
21 CFR 812.150(a)(3) - (3) Progress. An investigator shall submit progress reports on the investigation to the sponsor,...
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21 CFR 812.150(b) - (b) Sponsor reports. A sponsor shall prepare and submit the following complete, accurate, and ti...
21 CFR 812.150(b)(10) - (10) Other. A sponsor shall, upon request by a reviewing IRB or FDA, provide accurate, complete,...
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21 CFR 812.150(b)(2) - (2) Withdrawal of IRB approval. A sponsor shall notify FDA and all reviewing IRB's and participa...
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21 CFR 812.150(b)(5) - (5) Progress reports. At regular intervals, and at least yearly, a sponsor shall submit progress...
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21 CFR 812.150(b)(7) - (7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within ...
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21 CFR 812.150(b)(8) - (8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator unde...
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21 CFR 812.140 - Records.
21 CFR 812.140(d) - (d) Retention period. An investigator or sponsor shall maintain the records required by this sub...
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21 CFR 812.140(a) - (a) Investigator records. A participating investigator shall maintain the following accurate, co...
21 CFR 812.140(a)(1) - (1) All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, includi...
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21 CFR 812.140(a)(2) - (2) Records of receipt, use or disposition of a device that relate to:
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...
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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) - (3) Records of each subject's case history and exposure to the device
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21 CFR 812.140(a)(3)(i) - (i) Documents evidencing informed consent and, for any use of a device by the investigator withou...
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21 CFR 812.140(a)(3)(ii) - (ii) All relevant observations, including records concerning adverse device effects (whether anti...
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21 CFR 812.140(a)(3)(iii) - (iii) A record of the exposure of each subject to the investigational device, including the date ...
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21 CFR 812.140(b) - (b) Sponsor records. A sponsor shall maintain the following accurate, complete, and current reco...
21 CFR 812.140(b)(2) - (2) Records of shipment and disposition. Records of shipment shall include the name and address o...
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Part 820: Quality System Regulation
Subpart B: Quality System Requirements
21 CFR 820.25 - Personnel.
21 CFR 820.25(b) - (b) Training
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21 CFR 820.25(a) - (a) General. Each manufacturer shall have sufficient personnel with the necessary education, bac...
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21 CFR 820.25 - Personnel.
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21 CFR 820.22 - Quality audit.
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21 CFR 820.20 - Management responsibility.
21 CFR 820.20(d) - (d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality...
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21 CFR 820.20(c) - (c) Management review. Management with executive responsibility shall review the suitability and...
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21 CFR 820.20(e) - (e) Quality system procedures. Each manufacturer shall establish quality system procedures and i...
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21 CFR 820.20(a) - (a) Quality policy. Management with executive responsibility shall establish its policy and obje...
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21 CFR 820.20 - Management responsibility.
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21 CFR 820.20(b) - (b) Organization
21 CFR 820.20(b) - (b) Organization
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21 CFR 820.20(b)(2) - (2) Resources. Each manufacturer shall provide adequate resources, including the assignment of t...
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21 CFR 820.20(b)(3) - (3) Management representative
21 CFR 820.20(b)(3) - (3) Management representative
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21 CFR 820.20(b)(3)(i) - (i) Ensuring that quality system requirements are effectively established and effectively maintai...
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Subpart C: Design Controls
21 CFR 820.30 - Design controls.
21 CFR 820.30(h) - (h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that th...
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21 CFR 820.30(a) - (a) General.
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21 CFR 820.30(e) - (e) Design review. Each manufacturer shall establish and maintain procedures to ensure that form...
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21 CFR 820.30(g) - (g) Design validation. Each manufacturer shall establish and maintain procedures for validating ...
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21 CFR 820.30(i) - (i) Design changes. Each manufacturer shall establish and maintain procedures for the identifica...
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21 CFR 820.30(j) - (j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of d...
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21 CFR 820.30(b) - (b) Design and development planning. Each manufacturer shall establish and maintain plans that d...
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21 CFR 820.30(d) - (d) Design output. Each manufacturer shall establish and maintain procedures for defining and do...
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21 CFR 820.30(c) - (c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the d...
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21 CFR 820.30(f) - (f) Design verification. Each manufacturer shall establish and maintain procedures for verifying...
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21 CFR 820.30 - Design controls.
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Subpart D: Document Controls
21 CFR 820.40 - Document controls.
21 CFR 820.40(b) - (b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in...
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21 CFR 820.40(a) - (a) Document approval and distribution. Each manufacturer shall designate an individual(s) to re...
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21 CFR 820.40 - Document controls.
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Subpart E: Purchasing Controls
21 CFR 820.50 - Purchasing controls.
21 CFR 820.50(b) - (b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe o...
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21 CFR 820.50 - Purchasing controls.
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21 CFR 820.50(a) - (a) Evaluation of suppliers, contractors, and consultants
21 CFR 820.50(a) - (a) Evaluation of suppliers, contractors, and consultants
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21 CFR 820.50(a)(1) - (1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their a...
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21 CFR 820.50(a)(2) - (2) Define the type and extent of control to be exercised over the product, services, suppliers, ...
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21 CFR 820.50(a)(3) - (3) Establish and maintain records of acceptable suppliers, contractors, and consultants.
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Subpart F: Identification and Traceability
21 CFR 820.60 - Identification.
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Subpart G: Production and Process Controls
21 CFR 820.75 - Process validation.
21 CFR 820.75(a) - (a) Where the results of a process cannot be fully verified by subsequent inspection and test, th...
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21 CFR 820.75(c) - (c) When changes or process deviations occur, the manufacturer shall review and evaluate the proc...
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21 CFR 820.75 - Process validation.
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21 CFR 820.75(b) - (b) Each manufacturer shall establish and maintain procedures for monitoring and control of proce...
21 CFR 820.75(b) - (b) Each manufacturer shall establish and maintain procedures for monitoring and control of proce...
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21 CFR 820.75(b)(1) - (1) Each manufacturer shall ensure that validated processes are performed by qualified individual...
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21 CFR 820.75(b)(2) - (2) For validated processes, the monitoring and control methods and data, the date performed, and...
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21 CFR 820.70 - Production and process controls.
21 CFR 820.70(b) - (b) Production and process changes. Each manufacturer shall establish and maintain procedures fo...
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21 CFR 820.70(h) - (h) Manufacturing material. Where a manufacturing material could reasonably be expected to have ...
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21 CFR 820.70(f) - (f) Buildings. Buildings shall be of suitable design and contain sufficient space to perform nec...
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21 CFR 820.70(e) - (e) Contamination control. Each manufacturer shall establish and maintain procedures to prevent ...
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21 CFR 820.70(c) - (c) Environmental control. Where environmental conditions could reasonably be expected to have a...
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21 CFR 820.70(i) - (i) Automated processes. When computers or automated data processing systems are used as part of...
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21 CFR 820.70(d) - (d) Personnel. Each manufacturer shall establish and maintain requirements for the health, clean...
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21 CFR 820.70 - Production and process controls.
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21 CFR 820.70(a) - (a) General
21 CFR 820.70(a) - (a) General
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21 CFR 820.70(a)(1) - (1) Documented instructions, standard operating procedures (SOP's), and methods that define and c...
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21 CFR 820.70(a)(2) - (2) Monitoring and control of process parameters and component and device characteristics during ...
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21 CFR 820.70(g) - (g) Equipment
21 CFR 820.70(g) - (g) Equipment
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21 CFR 820.70(g)(1) - (1) Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjus...
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21 CFR 820.72 - Inspection, measuring, and test equipment.
21 CFR 820.72(a) - (a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that al...
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21 CFR 820.72(b) - (b) Calibration
21 CFR 820.72(b) - (b) Calibration
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21 CFR 820.72(b)(1) - (1) Calibration standards. Calibration standards used for inspection, measuring, and test equipm...
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Subpart H: Acceptance Activities
21 CFR 820.86 - Acceptance status.
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21 CFR 820.80 - Receiving, in-process, and finished device acceptance.
21 CFR 820.80(b) - (b) Receiving acceptance activities. Each manufacturer shall establish and maintain procedures f...
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21 CFR 820.80(c) - (c) In-process acceptance activities. Each manufacturer shall establish and maintain acceptance ...
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21 CFR 820.80(a) - (a) General. Each manufacturer shall establish and maintain procedures for acceptance activities...
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21 CFR 820.80 - Receiving, in-process, and finished device acceptance.
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21 CFR 820.80(e) - (e) Acceptance records
21 CFR 820.80(e) - (e) Acceptance records
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21 CFR 820.80(e)(3) - (3) the results;
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21 CFR 820.80(d) - (d) Final acceptance activities
21 CFR 820.80(d) - (d) Final acceptance activities
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21 CFR 820.80(d)(1) - (1) The activities required in the DMR are completed;
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Subpart I: Nonconforming Product
21 CFR 820.90 - Nonconforming product.
21 CFR 820.90(a) - (a) Control of nonconforming product. Each manufacturer shall establish and maintain procedures ...
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21 CFR 820.90 - Nonconforming product.
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21 CFR 820.90(b) - (b) Nonconformity review and disposition.
21 CFR 820.90(b) - (b) Nonconformity review and disposition.
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21 CFR 820.90(b)(1) - (1) Each manufacturer shall establish and maintain procedures that define the responsibility for ...
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21 CFR 820.90(b)(2) - (2) Each manufacturer shall establish and maintain procedures for rework, to include retesting an...
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Subpart J: Corrective and Preventive Action
21 CFR 820.100 - Corrective and preventive action.
21 CFR 820.100(b) - (b) All activities required under this section, and their results, shall be documented.
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21 CFR 820.100 - Corrective and preventive action.
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21 CFR 820.100(a) - (a) Each manufacturer shall establish and maintain procedures for implementing corrective and pre...
21 CFR 820.100(a) - (a) Each manufacturer shall establish and maintain procedures for implementing corrective and pre...
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21 CFR 820.100(a)(1) - (1) Analyzing processes, work operations, concessions, quality audit reports, quality records, se...
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21 CFR 820.100(a)(2) - (2) Investigating the cause of nonconformities relating to product, processes, and the quality sy...
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21 CFR 820.100(a)(3) - (3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product a...
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21 CFR 820.100(a)(4) - (4) Verifying or validating the corrective and preventive action to ensure that such action is ef...
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21 CFR 820.100(a)(5) - (5) Implementing and recording changes in methods and procedures needed to correct and prevent id...
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21 CFR 820.100(a)(6) - (6) Ensuring that information related to quality problems or nonconforming product is disseminate...
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21 CFR 820.100(a)(7) - (7) Submitting relevant information on identified quality problems, as well as corrective and pre...
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Subpart K: Labeling and Packaging Control
21 CFR 820.130 - Device packaging.
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21 CFR 820.120 - Device labeling.
21 CFR 820.120(b) - (b) Labeling inspection. Labeling shall not be released for storage or use until a designated in...
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21 CFR 820.120(d) - (d) Labeling operations. Each manufacturer shall control labeling and packaging operations to pr...
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21 CFR 820.120 - Device labeling.
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Subpart L: Handling, Storage, Distribution, and Installation
21 CFR 820.160 - Distribution.
21 CFR 820.160(b) - (b) Each manufacturer shall maintain distribution records which include or refer to the location ...
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21 CFR 820.160(a) - (a) Each manufacturer shall establish and maintain procedures for control and distribution of fin...
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21 CFR 820.170 - Installation.
21 CFR 820.170(b) - (b) The person installing the device shall ensure that the installation, inspection, and any requ...
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21 CFR 820.170(a) - (a) Each manufacturer of a device requiring installation shall establish and maintain adequate in...
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21 CFR 820.150 - Storage.
21 CFR 820.150(b) - (b) Each manufacturer shall establish and maintain procedures that describe the methods for autho...
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21 CFR 820.150(a) - (a) Each manufacturer shall establish and maintain procedures for the control of storage areas an...
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21 CFR 820.150 - Storage.
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21 CFR 820.140 - Handling.
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Subpart M: Records
21 CFR 820.181 - Device master record.
21 CFR 820.181(b) - (b) Production process specifications including the appropriate equipment specifications, product...
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21 CFR 820.181(a) - (a) Device specifications including appropriate drawings, composition, formulation, component spe...
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21 CFR 820.181(d) - (d) Packaging and labeling specifications, including methods and processes used; and
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21 CFR 820.181 - Device master record.
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21 CFR 820.180 - General requirements.
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21 CFR 820.198 - Complaint files.
21 CFR 820.198(d) - (d) Any complaint that represents an event which must be reported to FDA under part 803 of this c...
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21 CFR 820.198(e) - (e) When an investigation is made under this section, a record of the investigation shall be main...
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21 CFR 820.198(c) - (c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any ...
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21 CFR 820.198(b) - (b) Each manufacturer shall review and evaluate all complaints to determine whether an investigat...
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21 CFR 820.198 - Complaint files.
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21 CFR 820.198(a) - (a) Each manufacturer shall maintain complaint files
21 CFR 820.198(a) - (a) Each manufacturer shall maintain complaint files
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21 CFR 820.198(a)(1) - (1) All complaints are processed in a uniform and timely manner;
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21 CFR 820.198(a)(2) - (2) Oral complaints are documented upon receipt; and
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21 CFR 820.198(a)(3) - (3) Complaints are evaluated to determine whether the complaint represents an event which is requ...
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21 CFR 820.186 - Quality system record.
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21 CFR 820.184 - Device history record.
21 CFR 820.184(e) - (e) The primary identification label and labeling used for each production unit; and
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21 CFR 820.184(d) - (d) The acceptance records which demonstrate the device is manufactured in accordance with the DM...
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21 CFR 820.184 - Device history record.
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Subpart N: Servicing
21 CFR 820.200 - Servicing.
21 CFR 820.200(a) - (a) Where servicing is a specified requirement, each manufacturer shall establish and maintain in...
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21 CFR 820.200(b) - (b) Each manufacturer shall analyze service reports with appropriate statistical methodology in a...
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21 CFR 820.200(c) - (c) Each manufacturer who receives a service report that represents an event which must be report...
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21 CFR 820.200 - Servicing.
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Subpart O: Statistical Techniques
21 CFR 820.250 - Statistical techniques.
21 CFR 820.250(b) - (b) Sampling plans, when used, shall be written and based on a valid statistical rationale. Each ...
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21 CFR 820.250(a) - (a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying ...
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21 CFR 820.250 - Statistical techniques.
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Part 830: Unique Device Identification
Subpart A: Global Unique Device Identification Database
21 CFR 830.300 - Devices subject to device identification data submission requirements.
21 CFR 830.300(a) - (a) In general. The labeler of a device must provide the information required by this subpart fo...
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