Part 806 Medical Device

合集下载

美国FDA_医疗器械体系法规QSR820中英文版

美国FDA 医疗器械体系法规QSR820中文版Part 820——质量体系法规——目录Subpart A- 总则820.1 范围820.3 定义820.5 质量体系Subpart B –质量体系要求820.20 管理职责820.22 质量审核820.25 人员Subpart C- 设计控制820.30 设计控制Subpart D- 文件控制820.40 文件控制Subpart E- 采购控制820.50 采购控制Subpart F- 标识与可追溯性820.60 标识820.65 可追溯性Subpart G - 生产和过程控制820.70 生产和过程控制820.72 检验、测量和试验设备820.75 过程确认Subpart H - 验收活动:820.80 进货、过程和成品器械检验820.86 检验状态Subpart I –不合格品820.90 不合格品Subpart J - 纠正和预防措施820.100 纠正和预防措施Subpart K –标识和包装控制820.120 设备标签820.130 设备包装Subpart L –搬运/储存/分销和安装820.140 搬运820.150 贮存820.160 分销820.170 安装Subpart L –记录820.180 记录的通用要求820.181 设备主要记录820.184 设备历史记录820.186 质量体系记录820.198 投诉文件Subpart M –服务820.200 服务Subpart N –统计技术820.250 统计技术Subpart A——总则Subpart A--General ProvisionsSec.820.1 范围Sec. 820.1 Scope.（a）适用性Applicability。

（1）本质量体系法规阐明了当前良好制造法规Current good manufacturing practice （CGMP）的要求。

本标准适用于所有预期用于人类的成品器械的设计、制造、包装、标识、储存、安装和服务中所使用的管理方法、设施和控制。

Philips Ultrasound, Inc. Collaboration Live - 商品说明

Philips Ultrasound, Inc. September 15, 2020℅ Mr. Colin S. JacobSenior Regulatory Affairs Specialist22100 Bothell Everett HighwayBOTHELL WA 98021Re: K201665Trade/Device Name: Collaboration LiveRegulation Number: 21 CFR 892.2050Regulation Name: Picture archiving and communications systemRegulatory Class: Class IIProduct Code: LLZ, IYN, IYODated: August 10, 2020Received: August 11, 2020Dear Mr. Jacob:We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https:///scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (seeK201665 – Mr. Colin Jacob Page 2 https:///combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https:///medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https:///medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn(https:///training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https:///medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (************.gov) or phone (1-800-638-2041 or 301-796-7100).Sincerely,ForThalia T. Mills, Ph.D.DirectorDivision of Radiological HealthOHT7: Office of In Vitro Diagnosticsand Radiological HealthOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthEnclosureTraditional 510(k)Collaboration Live Page 1 of 4 K201665510(k) SummaryThis summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.Date Prepared: September 14, 2020I.SubmitterManufacturer Name Philips Ultrasound, Inc.and Address 22100 Bothell Everett HwyBothell, WA 98021-8431Contact Colin S. JacobInformation Senior Regulatory Affairs SpecialistTEL: +1 (425)-908-1209EMAIL: ***********************Secondary Contact Benny LamInformation Principal Regulatory Affairs SpecialistTEL: +1 (425)-215-3496EMAIL: *********************II.DeviceTrade Name Collaboration LiveCommon Name System, Image Processing, RadiologicalRegulation Description Picture archiving and communications system (Primary)Ultrasonic pulsed doppler imaging systemUltrasonic pulsed echo imaging systemRegulation Number 892.2050 (Primary)892.1550892.1560Product Code LLZ (Primary)IYNIYODevice Class Class IIReview Panel RadiologyI.Predicate DeviceCollaboration Live – Philips Ultrasound (K200179)II.Device DescriptionCollaboration Live is software-based communication feature integrated in Philips Diagnostic Ultrasound Systems. Collaboration Live together with remote-client Reacts enables two-way communication of text, voice, image, and video information between an ultrasound local system operator and a remote healthcare professional on a Windows device. Collaboration Live-Reacts facilitates: 1) remote diagnostic viewing and review, 2) remote clinical training and education, 3) remote peer-to-peer collaboration, and 4) remote service support. Collaboration Live functionality includes a remote control feature in which the ultrasound local system operator may grant a qualified remote user control of the ultrasound system parameters via a virtual control panel and virtual touch screen. By meeting the technical, operator, and environment requirements specified in the User Manual, healthcare professionals using Reacts may provide clinical diagnoses from a remote location as they would directly on the ultrasound system.III.Indications for UseCollaboration Live is indicated for remote console access of the Philips ultrasound system for diagnostic image viewing and review, consultation, guidance, support, and education in real time. Access must be granted by the healthcare professionals operating the ultrasound system. Compliance with the technical and operator requirements specified in the User Manual is required.It is the responsibility of the healthcare professionals at the remote client to ensure image quality, display contrast, and ambient light conditions are consistent with the generally accepted standards of the clinical application.IV.Comparison of Technological Characteristics with the Predicate DeviceManufacturer Philips Ultrasound, Inc. Philips Ultrasound, Inc. Same Regulation Name Picture Archiving and Communications System (PACS) Picture Archiving and Communications System (PACS) Same Product Code(s) Primary: LLZ Secondary: IYN, IYO Primary: LLZ Secondary: IYN, IYO Same Indications for Use Collaboration Live is indicated for remote console access of the Philips ultrasound system for diagnostic image viewing and review, consultation, guidance, support, and education in real time. Access must be granted by the healthcare professionals operating the ultrasound system. Compliance with the technical and operator requirements specified in the User Manual is required. It is the responsibility of the healthcare professionals at the remote client to ensure image quality, display contrast, and ambient light conditions are consistent with the generally accepted standards of the clinical application. Collaboration Live is indicated for remote console access of the Philips ultrasound system for image viewing, image review, consultation, guidance, support, and education in real time. Access must be granted by the technologist operating the system. Images reviewed remotely are not for diagnostic use. Both device are indicated for image review and viewing at remote location over the Internet. They are intended for ultrasound image review and viewing, remote control, and communication in real time. The predicate is not indicated for diagnostic use. Features Image viewing and review Text Chat Voice Calling Video Calling Remote Asset Sharing Remote Control Image viewing and review Text Chat Voice Calling Video Calling Remote Asset Sharing Remote Control Same Local System Hardware Philips EPIQ or Affiniti ultrasound system Philips EPIQ or Affiniti ultrasound system Same Remote System Hardware Commercially available off-the-shelf computer hardware Commercially available off-the-shelf computer hardware SameSupported Imaging Modalities Ultrasound Ultrasound SameIntended Users Qualified healthcareprofessionalsQualified healthcareprofessionals SameRemote-clientUse EnvironmentClinical environment withambient light conditionconsistent with the generallyaccepted standards of theclinical application.Clinical environmentSubject device has anadditional requirementfor ambient lightcondition.Remote DiagnosticUseImage visualized fordiagnostic review andviewing on remote-clientReactsNoThe predicate is notindicated for diagnosticuse.V.Validation Testing SummaryValidation testing with pre-determined criteria was conducted to evaluate the equivalency of remote viewing and review comparing to local ultrasound systems using Collaboration Live and remote-client Reacts. Remote display specifications and network bandwidth requirements for equivalent image quality for diagnostic viewing were determined. Labeling materials have been updated to inform the users regarding the requirements for safe and effective remote diagnostic review and viewing.VI.ConclusionThe device functionalities, intended users, and performance of the subject Collaboration Live software, remote-client Reacts, and Philips diagnostic ultrasound systems, which Collaboration Live runs on, remain unchanged comparing to the predicate.The change in indications for use of ultrasound images to be viewed and reviewed remotely for diagnostic purpose on remote-client Reacts, increases options to image patients inside and outside of healthcare facilities, expands the number of healthcare professionals capable of performing ultrasound imaging technique, which could help limit the risk of exposure for healthcare workers and patients to the infectious diseases such as COVID-19.The results of the design control activity suggest that the subject device does not raise new questions of safety or effectiveness. The validation testing and labeling are adequate to support the substantial equivalent determination to the predicate device.。

美国FDA医疗器械体系法规QSR820中英文版

（1）本质量体系法规阐明了当前良好制造法规Current good manufacturing practice （CGMP）的要求。

本标准适用于所有预期用于人类的成品器械的设计、制造、包装、标识、储存、安装和服务中所使用的管理方法、设施和控制。

Medical-Device-Law医疗器械法规教程文件

High Risk Devices
Pacemakers
Subject to Catastrophic Failure Also Bribery Issues
Anesthesia Machines
Marginally Competent Personnel The O-Ring Congress Decides to Regulate Devices MDA of 1976
Court Struck them
MA would need to ask for an exemption under the statutory process
Cipollone v. Liggett Group
Tobacco Labeling Act (1967?) Required Standard Labels Said State Could Impose No Other Labeling
Exemption Cases
State Consumer Fraud State Regulation of Professions Hearing Aids
MA set standards for disclosure and marketing of hearing aids
These were challenged as additional requirements under 360k
Medical-Device-Law医疗器械法规
Safety, Not Efficacy
No Regulation of Efficacy Safety Only As Regards Direct Hazard No Consideration of Danger of Improper

Medical Devices

HUMAN RESEARCH PROTECTIONS PROGRAMMedical DevicesPolicyThe United States Food and Drug Administration (FDA) provides the regulations regarding review of research associated with devices. These regulations include 21 CFR 50 (“Protection of Human Subjects”); 21 CFR 56 (“Institutional Review Boards”), and 21 CFR 812 (“Investigational Device Exemptions”).Guidance from the FDA notes that a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is recognized in the official National Formulary or the United States Pharmacopeia, or any supplement to them; intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. [21 U.S.C. 321(h)]When the proposed research involves an investigational device, the Institutional Review Board (IRB) will determine whether the device is a significant risk (SR) or a non-significant risk (NSR) device. This assessment will be based on the information provided by the investigator and/or the sponsor including a description of the device, and reports of prior investigations conducted with the device, a copy of the FDA’s device determination letter, and other sources as applicable. The investigator and/or sponsor should also provide a clear and specific risk assessment as well as their rationale in making the SR or NSR determination.The determination of device risk will be based on the proposed use of the device, as well as any protocol-related procedures and tests, and not the device alone.If the device has previously been determined to be a SR or NSR device by the FDA, it will be treated as such by the IRB. Guidance form the FDA notes that the agency’s determination is final. When an IDE is provided, the IRB will confirm that number is on file with the FDA. This may be done by reviewing information provided by the investigator and/or sponsor such as the protocol or letter from the FDA or checked on the FDA website.If the device has previously been determined to be a NSR device by the sponsor, the IRB may agree or disagree with that assessment. The assessment of risk by the IRB will be voted on as part of its review and documented in the minutes.The SR/NSR determination will be conducted before the IRB conducts the review of the study under 21 CFR 56 and 45 CFR 46. Guidance from the FDA includes “The judgment about whether a study poses a significant risk or nonsignificant risk is based on the significance of thepotential harm that may result from participation in the study including the use of the device;whereas the IRB’s decision to approve for implementation is based on the study’s risk-benefit assessment.”Significant Risk DevicesA device will be determined to be a significant risk device if any of the following criteria apply:a. The device is intended as an implant.b. The device supports or sustains human life.c. The use of the device is of substantial importance in diagnosing, curing, mitigating, ortreating disease, or preventing impairment of health.d. The device could cause significant harm to any subjects.e. The subject must undergo a procedure as part of the device study.f. The device appears on the FDA list of significant risk devices.g. the study or any of the study procedures could cause harm to the subjects which:1. could be life threatening,2. could cause permanent impairment of a body function,3. could cause permanent damage to body structure, or4. could necessitate medical or surgical intervention to preclude permanentimpairment of a body function or preclude permanent damage to bodystructure.When the IRB determines that the device is a significant risk device, and an IDE is not provided with the submission, the IRB will notify the investigator and, where appropriate, the sponsor and the FDA. No further action will be taken by the IRB on the research until the sponsor or investigator has filed an IDE application and has met the requirements for a SR study described in 21 CFR 812, or has obtained an equivalent approval (e.g., 510(k) approval) from the FDA and provided documentation of this approval to the IRB.Non-significant Risk DevicesA non-significant risk device is a device that does not meet the definition of a significant risk device.If the investigator and/or sponsor identifies a study as NSR, the investigator must provide an explanation of such determination and any other information that may help the IRB to evaluate the risk of the study/device including a clear description of the device, reports of prior investigations with the device other information as appropriate.When the IRB determines that the device is a non-significant risk device, the IRB proceeds to review the study under requisite criteria for any study. A NSR device investigation does not require the sponsor to first obtain an approved IDE before beginning the study provided certain other requirements are met. The FDA considers an NSR device study to have an approved IDE after IRB approval and when sponsors meet the abbreviated requirements at 21 CFR 812.2(b). If those abbreviated requirements are met, the sponsor is considered to have an approved IDE in place.Exempted DevicesSome medical devices are exempted from 21 CFR 812 filing requirements and do not require an approved IDE, provided certain conditions are met. However, these kinds of device investigations still require IRB review and informed consent compliance. These include the following:2DEVICE.DOCa. A device, other than a transitional device, in commercial distribution immediatelybefore May 28, 1976, when used or investigated in accordance with the indications inlabeling in effect at that time.b. A device, other than a transitional device, introduced into commercial distribution on orafter May 28, 1976, that FDA has determined to be substantially equivalent to a devicein commercial distribution immediately before May 28, 1976, and that is used orinvestigated in accordance with the indications in the labeling FDA reviewed undersubpart E of part 807 in determining substantial equivalence.c. A diagnostic device, if the sponsor complies with applicable requirements in Sec.809.10(c) and if the testing: (1) Is noninvasive, (2) Does not require an invasivesampling procedure that presents significant risk, (3) Does not by design or intentionintroduce energy into a subject, and (4) Is not used as a diagnostic procedure withoutconfirmation of the diagnosis by another, medically established diagnostic product orprocedure. Note: In vitro diagnostic (IVD) device research where the investigationmeets the IDE exemption criteria at 21 CFR 812.2(c) (3); and there is NO possibility oflinkage between the “leftover” sample, that is, remnants of specimens collected forroutine clinical care or analysis that would have been discarded, and subjectidentification (e.g., surplus blood sample that is coded but the coding cannot be linkedto the source subject) and where results of the investigational test are notcommunicated to or otherwise associated with the identified subject; individuals caringfor the patients are different from and do not share information about the patient withthose conducting the investigation including the sponsor; the specimens are provided to the investigator(s) without identifiers and the supplier of the specimens has establishedpolicies and procedures to prevent the release of personal information does not requireInformed Consent compliance.d. A device undergoing consumer preference testing, testing of a modification, or testingof a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk.e. A device intended solely for veterinary use.f. A device shipped solely for research on or with laboratory animals and labeled inaccordance with Sec. 812.5(c).g. A custom device as defined in Sec. 812.3(b), unless the device is being used todetermine safety or effectiveness for commercial distribution.510(k) DeviceThe FDA notes that a premarket notification, or 501(k), is submitted to the FDA before a manufacturer proposes to market a medical device. If the FDA agrees the new device is substantially equivalent to a legally marketed device for which premarket approval is not required, the manufacturer may market the device immediately. The FDA does not require clinical data on most 510(k)s. The exemption in 21 CFR 812.2(c)(2) applies only to investigations in which the 510(k) product is being used in accordance with the labeling clearly by the FDA. However, if clinical data are necessary to demonstrate substantial equivalence, the clinical study must comply with the IDE, IRB and human subjects protection regulations. Further, “off-label” use of a 510(k) product take the product outside the exemption. A device subject to 510(k) remains investigational until the 510(k) is cleared by the FDA and the investigational use is subject to the requirements of the IDE, IRB and human subjects protection regulations [21 CFR 812, 50, and 56].What is submitted to the IRB for review of an Investigational Device?1. An appropriately completed Biomed Standard Facesheets and BiomedicalApplication Research Plan including such information as a clear and specificdescription of the device; a clear and specific risk assessment as to whether thedevice is SR or NSR, and the rationale used to make this determination; etc.2. A copy of relevant reports of prior investigations conducted with the device.3. A copy of the FDA’s device determination letter.4. Other sources of information regarding the device and use of the device, asappropriate.5. The consent document(s) to be used.Humanitarian Use DevicesA Humanitarian Use Device (HUD) is a device that is determined to meet specific requirements including scientific rationale and population prevalence by the Office of Orphan Products Development. As such, the general criteria for an HUD, as outlined on the FDA Website are as follows:a. Expected to benefit fewer than 4,000 people in the US per year (in some FDAinformation sheets, worded more narrowly as “is designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States.”).b. No comparable device already available.c. No exposure to “unreasonable or significant risk of illness or injury.”d. Potential benefits of the device outweigh its risks.The FDA grants a Humanitarian Device Exemption (HDE) that authorizes the “marketing” of an HUD. A HDE is an application that is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of sections 514 and 515 of the Food, Drug and Cosmetic Act (the Act). FDA approval of an HDE authorizes an applicant to market a HUD, subject to certain profit and use restrictions set forth in section 520(m) of the Act.Current draft guidance from the FDA notes that because an SR/NSR determination applies only to device research studies, when the HUD is being used within the approved labeling (i.e., not for research), the IRB is not required to provide a SR/NSR determination.What is submitted to the IRB for review of a HUD?Though the IRB recognizes that the use of an HUD is not typically research, for the initial review of the HUD, the IRB requests the following materials be provided:1. An appropriately completed Biomed Standard Facesheets and BiomedicalApplication Research Plan providing such information as a summary of how thephysician proposes to use the device; a description of any screening procedures;the HUD procedure; any patient follow-up visits, tests or procedures risks; howrisks will be managed; justification that risks are reasonable in relation to theproposed use of the device; costs to the patient; privileges/certifications andlicenses; etc.2. A copy of the HDE approval order.3. A clear and specific description of the device.4DEVICE.DOC4. The product labeling.5. The patient information packet.6. The consent document to be used.How is a HDE different from a Investigational Device Exemption (IDE)?A HUD will most likely never obtain the efficacy data required for an ordinary Pre-Market Approval by the FDA. Although the HUD designation contains some of the elements found in an IDE, the “approval” for the use of a HUD includes the provisions that the IRB provide oversight (initial and continuing review). Guidance from the FDA notes “…once the HDE is approved, the HDE holder is responsible for ensuring that the approved HUD is only administered at institutions that have an IRB constituted and acting pursuant to 21 CFR 56 including conducting continuing review of the use of the HUD…HUDs should not be used until AFTER the HDE applicant obtains approval of the HDE from FDA and IRB approves its use. IRBs should ensure that HDE approval has been granted before approving the device for use at their institution.” In addition, the clinician/investigator must abide by the label indications.Clinicians and investigators must obtain IRB approval as stipulated in 21 CFR 814.124(a). It is suggested that the application contain a predefined number of recipients so that case-by-case IRB oversight is not required unless the IRB for some special reason decides that interims are necessary. The regulations also require that a fully convened IRB review the application. Although the device might be minimal risk in nature, the regulations do not allow expedited review. For continuing review, however, IRBs may use the expedited review procedures unless the IRB determines that full board review should be performed. Humanitarian Device Exemptions will be reviewed in compliance with the provisions of 21 CFR 814.124(a), which establishes the requirement for initial and continuing IRB review. When reviewing an HDE, the IRB will follow the review criteria in 21 CFR 56.111 and elsewhere in Part 56, and 45 CFR 46, as much as possible. The IRB will review the risks to patient and ensure that risk are minimized and that risks are reasonable in relation to the proposed use of the device.Should an investigator or HDE holder develop a research protocol designed to collect safety and effectiveness data to support a PMA for the device, an IDE would not be needed if the research is within the approved labeling. However, IRB approval must be obtained before research may begin as this would be considered an FDA-regulated clinical investigation. Subjects must also be consented using an IRB-approved consent document. If the research is for a “new use,” the IDE regulations must be followed. [21 CFR Parts 812, 50, and 56] HUD and Informed ConsentThe regulations, as provided by the FDA, state that informed consent is not required for the use of a HUD “Because an HDE provides for marketing approval, use of the HUD does not constitute research or an investigation which would normally require consent from the study subjects.” Guidance from the FDA includes, “However, there is nothing in the law or regulations that prohibits a state or institution from requiring prospective informed consent, when feasible.”UCSD IRBs require review and approval of a consent document when a study is associated with an HUD/HDE. It is suggested that the clinicians/investigator, for purposes ofdocumentation, should note that the patient has been told that the device has not beenlicensed in the ordinary manner (and/or that it has not been proven to be safe and effective by the usual criteria). Participants should also be provided with current labeling information if available. Typically, the consent will include information provided in the patient information packet such as a description of any ancillary procedures associated with the use of the HUD;a description of the use of the HUD; all know risks or discomforts; an explanation of how thedevice may work in relation to the disease or condition, etc., as well as stating, “AHumanitarian Device Exemption is a special FDA category for a device that can be used by a physician that is exempt from FDA effectiveness requirements and for which no comparable is available to treat [the disease or condition]. The device is intended to benefit patients in the [treatment or diagnosis] of your condition in 4,000 individuals in the United States per year.The effectiveness of this device for this use has not been demonstrated.”Off-label Use of a HUDThe FDA requires that the off-label use of a HUD be reported to the IRB and that theinvestigator notifies the manufacturer of the proposed use of the device. As such, the use might constitute an amendment to the HDE or may require an IDE.The off-label use of a HUD in an emergency that cannot wait for IRB action should betreated in the same manner that an emergency use of an investigational drug or device of any other type would be handled. Criterion for the emergency off-label use would include the following:1. A life-and-limb-threatening emergency and that the urgency of situation does notallow time for IRB review2. No other standard (or already IRB-approved) intervention available can be used witha reasonable chance of success3. No regulatory barriers (i.e.,within HDE provisions, or steps begun to obtain specialapproval) (usually handled by emergency communication with HDE sponsor)4. (If consent must be waived) Physician uninvolved in patient’s care concursA formal report to IRB within 5 working days including identification of the patientinvolved, the date of use, and the reason for the use; formal application must be provided if additional patients likely.Procedures Associated with the Use of Devices at UCSD Medical Center Additional procedures are required when an investigational device or HUD is used at UCSD Medical Center. For example, a “new” procedure code may need to be established, and should sponsor representatives be present in the patient care area during a procedure, credentialing and appropriate agreements must be in place. In addition, the Research Plan and consent must clearly reflect any procedures, risks, risk management procedures, etc. associated with the presence of such a representative.Further, the device may require review by the UCSD Medical Center Technology Assessment Committee (TAC) in order to evaluate the proposed impact to UCSD Medical Center. Though IRB approval may be granted, TAC may place the study on “hold” pending their review and6DEVICE.DOCapproval.For more information about these procedures, review and the use of devices at UCSD Medical Center, contact the Research Compliance Program at rcp@ or (619) 543-5841. Applicable Regulations21 CFR 81221 CFR 812.2(b)(1)(ii)21 CFR 812.6621 CFR 814.124(a)21 CFR 5021 CFR 56.107(e-f)21 CFR 56.108(a)(1-2)21 CFR 56.108(c)21 CFR 56.109(a-f)21 CFR 56.11145 CFR 46.108 (a)45 CFR 46.103 (b) (4-5)45 CFR 46.107 (e, f)45 CFR 46.108 (b)45 CFR 46.109 (a-e)45 CFR 46.11138 CFR 16.108 (a)38 CFR 16.103 (b) (4-5)38 CFR 16.107 (a, e, f)38 CFR 16.108 (b)38 CFR 16.109 (a-e)38 CFR 16.111ICH 3.1Federal Food, Drug and Cosmetic ActCalifornia Health and Safety Code 445VHA Handbook 1200.05Links/cdrh/ode/guidance/1668.pdf- Humanitarian Device Exemption Review Draft Guidelines/oc/ohrt/irbs/devices.html - Guidance for IRBs and Clinical Investigators regarding Medical Devices/oc/ohrt/irbs/devrisk.pdf- Guidance for IRBs, Clinical Investigators and Sponsors regarding Significant Risk and Nonsignificant Risk Medical Device Studies/oc/ohrt/irbs/irbreview.pdf - Guidance for IRBs, Clinical Investigators and Sponsors FAQ about Medical Devices/cdrh/ode/idepolcy.pdf - Guidance on IDE Policies and Procedures。

医疗器械警戒系统第8版新增部分内容

医疗器械警戒系统第8版新增部分内容第一篇：医疗器械警戒系统第8版新增部分内容警戒系统V8.0新增部分适用范围增加土耳其4.1.1增加以下内容这样的行动，是否相关有直接或间接的伤害，应当上报，并通过市场安全通知加以传达注释2 制造商可以作为正在进行的质量保证或在制造现场进行调查的一部分，根据制造商提供的使用信息中指定的特性来识别设备的故障。

如果故障可能导致或可能导致与使用医疗器械相关的健康状况的死亡或严重恶化，并且对已经投放市场的产品产生影响，则制造商必须发起FSCA。

故障模式的示例可以包括软件异常（例如，患者样本与获得的结果之间的不正确相关性）无效的控制、无效的校准或试剂故障（例如污染、转录错误和降低的稳定性）。

注释3 设备修改可以包括：对标签或使用说明书的永久性或临时性变更。

例如：-与设备使用方式的改变有关的建议，例如制造商建议修改的质量控制程序，例如使用第三方控制或对设备的控制值进行更频繁的校准或修改。

-与IVD一起使用的样品的储存条件的变化-向用户发出的关于IVF/ART设备（例如IVF/ART制造商）的保质期的改变的通知通知用户在其设备的标签上出现错误，这表明产品的保质期比产品的有效保质期长软件升级后，在该领域的软件版本的故障识别（这应该被报告，不管软件更新是否由客户、现场服务工程师或通过远程访问来实现）注释4不适用制造商提出的建议可包括对患者/样品的临床管理进行修改，以解决与设备的特性有关的死亡状态或严重恶化的健康状态的风险。

例如：-对于植入式设备，临床上通常不合理地对装置进行解剖。

采取特殊患者随访的纠正措施，不论是否有任何未植入的植入装置仍然可返回，构成FSCA。

-对于诊断装置（例如，IVD、成像设备或设备），采取召回患者或患者样本进行再测试或回顾以前结果的纠正措施构成FSCA。

注5：不适用本指南使用FSCA的定义作为MDD第10条（1）、第1B段中提到的召回的同义词和第11条IVD指令，因为没有一致的召回定义。

MEDICAL DEVICES ACT_2015

MEDICAL DEVICES ACT医疗器械法案[Enforcement Date 29. Jul, 2015.] [Act No.13116, 28. Jan, 2015., Partial Amendment]【生效日期：2015年7月29日】【法案编号：13116，2015年1月28日，部分修订】CHAPTER I GENERAL PROVISIONS第一章总则Article 1 (Purpose)第1条（目的）The purpose of this Act is to promote the efficient management of medical devices and further contribute to the improvement of national health by providing for matters concerning the manufacturing, importation, distribution, etc. of medical devices.制定本法案的目的旨在促进对医疗器械的有效管理，并通过对医疗器械制造、进口及分销等相关事项作出规定进而改善国民健康。

Article 2 (Definitions) (1) The term "medical device" in this Act means an instrument, machine, device, material, or any other similar product specified in the following subparagraphs as one used, alone or in combination, for human beings or animals: Provided, That the drugs and quasi-drugs under the Pharmaceutical Affairs Act and the prosthetic limbs and aids among assistive devices for persons with disabilities under Article 65 of the Act on Welfare of Persons with Disabilities shall be excluded herefrom:第2条（定义）（1）本法案中“医疗器械”是指下列子项中规定的单独或者共同用于人类或者动物的仪器、机械、设备、材料或者任何类似的产品，但《药事法》中规定的药品和医药部外品以及《残疾人福利法案》第65条中规定的残疾人使用的辅助设备中的假肢和假体辅助设施不包括在内：1. A product used for the purpose of diagnosing, curing, alleviating, treating, or preventing a disease;1.用于诊断、医治、缓解、治疗或者预防疾病的产品；2. A product used for the purpose of diagnosing, curing, alleviating, or correcting an injury or impairment;2.用于诊断、医治、缓解或者纠正伤残或者损伤的产品；3. A product used for the purpose of testing, replacing, or transforming a structure or function;3.用于检验、替代或者改变结构或者功能的产品；4. A product used for birth control.4.用于生育控制的产品。

新版美国FDA医疗器械标准体系法规QSR中英文版

美国FDA 医疗器械体系法规QSR820汉字版Part 820——质量体系法规——目录Subpart A- 总则820.1 范围820.3 定义820.5 质量体系Subpart B –质量体系要求820.20 管理职责820.22 质量审核820.25 人员Subpart C- 设计控制820.30 设计控制Subpart D- 文件控制820.40 文件控制Subpart E- 采购控制820.50 采购控制Subpart F- 标识和可追溯性820.60 标识820.65 可追溯性Subpart G - 生产和过程控制820.70 生产和过程控制820.72 检验、测量和试验设备820.75 过程确定Subpart H - 验收活动:820.80 进货、过程和成品器械检验820.86 检验状态Subpart I –不合格品820.90 不合格品Subpart J - 纠正和预防方法820.100 纠正和预防方法Subpart K –标识和包装控制820.120 设备标签820.130 设备包装Subpart L –搬运/储存/分销和安装820.140 搬运820.150 贮存820.160 分销820.170 安装Subpart L –统计820.180 统计通用要求820.181 设备关键统计820.184 设备历史统计820.186 质量体系统计820.198 投诉文件Subpart M –服务820.200 服务Subpart N –统计技术820.250 统计技术Subpart A——总则Subpart A--General ProvisionsSec.820.1 范围Sec. 820.1 Scope.（a）适用性Applicability。

（1）本质量体系法规说明了目前良好制造法规Current good manufacturing practice （CGMP）要求。

本标准适适用于全部预期用于人类成品器械设计、制造、包装、标识、储存、安装和服务中所使用管理方法、设施和控制。

美国记忆公司医疗器械产品目录

美国记忆公司医疗器械产品目录1、法规：21 CFR part 610 & 660，21 CFR part 862~892中规定的16个大类和1700个小类。

2. 分类：三个类别。

根据风险等级的不同，FDA将医疗器械分为三类（Ⅰ，Ⅱ，Ⅲ），Ⅲ类风险等级最高。

FDA将每一种医疗器械都明确规定其产品分类和管理要求，在1700多种医疗器械产品目录中。

任何一种医疗器械想要进入美国市场，必须首先弄清申请上市产品分类和管理要求。

3. 分类流程①根据FD&C 201(h)，确定是否是医疗器械；②根据21 CFR part 862~892，确定器械的具体分类项目；③或搜索FDA产品分类数据库，确定器械的具体分类项目；④或搜索PMA、510(k)、De Novo、HDE等系统数据库，确定器械的具体分类项目，主要针对II类和III类器械；⑤或搜索FDA产品列示数据库，确定器械具体分类项目，主要针对I类器械。

4. 注意事项①绝大部分I类器械为合法上市器械不需要510(k)，仅需FDA 注册和列示；②带星号（*）的I类器械常规情况下不需要GMP管理，前提条件是器械没有贴标签或没有被认定为无菌，但CFR 820.180和820.198有特殊规定的器械除外；③部分特殊受控的II类器械为合法上市器械不需要510(k)，但依然需要GMP管理（QSR820体系），除此外其他器械同时需要510(k)和GMP管理；④用于多种器械的软件，被认定为独立的医疗器械，具体参考FDA移动设备app指导文件；⑤对于移动设备app或软件，如果是用于通用健康管理的低风险设备，可能并不受FDA管辖，具体参考FDA 通用健康用器械的指导文件；⑥带有药物或生物制剂并用于诊断或治疗用途的器械，因涉及到多部门的审核，需要咨询FDA OCP部门。

1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES

PART 806 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS

Subpart A--General Provisions Sec. 806.1 Scope. (a) This part implements the provisions of section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.

(b) The following actions are exempt from the reporting requirements of this part:

(1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device.

(2) Market withdrawals as defined in 806.2(h). (3) Routine servicing as defined in 806.2(k). (4) Stock recoveries as defined in 806.2(l). [62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998] Sec. 806.2 Definitions. As used in this part: (a)Act means the Federal Food, Drug, and Cosmetic Act. (b)Agency or FDA means the Food and Drug Administration. (c)Consignee means any person or firm that has received, purchased, or used a device subject to correction or removal.

(d)Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other

[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2011] [CITE: 21CFR806] location.

(e)Correction or removal report number means the number that uniquely identifies each report submitted.

(f)Importer means, for the purposes of this part, any person who imports a device into the United States.

(g)Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedures. The term includes any person who:

(1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user or consumer;

(2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; or

(3) Manufactures components or accessories which are devices that are ready to be used and are intended to be commercially distributed and are intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient.

(h)Market withdrawal means a correction or removal of a distributed device that involves a minor violation of the act that would not be subject to legal action by FDA or that involves no violation of the act, e.g., normal stock rotation practices.

(i)Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

(j)Risk to health means (1) A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or

(2) That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.

(k)Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing.

(l)Stock recovery means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or