日本监狱法的新发展——《刑事收容设施及被收容者处遇法》评介

日本于2006年6月8日颁布了《刑事收容设施及被收容者处遇法》，施行近100年的《监狱法》全面退出了历史舞台。其出台经历了一个极为漫长和艰难的历史历程。该法内容相当完善，实现了刑事设施、留置设施、海上保安留置设施在管理运营上的统一，实现了服刑者、未决拘禁者、死刑确定者、被留置者在收容处遇上的平衡。立法用语中性、收容处遇人道、法律规则精密、救济机制完善为该法鲜明特色。无论是从法律文本分析还是对施行实践考察，该法都是极为成功。在转变理念、立法技术、法律落实等方面它对我国立法有一定的借鉴意义。     

试论《食品安全法》中关于消费者权益保护的欠缺

消费者是食品链中最大的群体。《食品安全法》的立法之本是为了保护消费者的安全,但是《食品安全法》在消费者权益保护方面却存在很多问题,比如,食品安全概念的狭隘,某些法条难以实施,与其它法律之间互相矛盾等。本文分析了《食品安全法》关于消费者权益保护的欠缺之处,并提出了修改建议。食品药品监督管理总局的成立及食品安全监管部门职能的调整改变了以前分段管理的模式,《食品安全法》要做相应的修改。希望在《食品安全法》的修订过程中可以加强对消费者权益的保护,增加该法的实用性。     

我国矿山劳动安全立法初论

我国矿山劳动安全法律体系虽已形成了以《宪法》和《劳动法》为根基,以《安全生产法》和《矿山安全法》为主干,以《刑法》、《工会法》、资源法、企业法相关条款和大量行政法规、部门规章和地方立法为枝叶的较为完整的法律体系,但是,在这一宏观体系内,还存在着立法目的多元化、法律内容滞后、法律空白、法律之间的相互矛盾等许多问题,有待于改进和完善。因此,应树立以人为本的立法指导思想,以劳动者人身安全与健康作为现阶段矿山劳动安全立法的唯一目的;尽快修改《矿山安全法》及其实施条例;制定《安全生产法实施条例》;及时梳理其他与矿山安全有关的法律法规,保证立法的协调一致,消除立法空白。     

中国立法的重大转型——2003年立法盘点

2003年3月,随着九届全国人大及其常委会落下帷幕,十 届全国人大及其常委会正式诞生。开局之年,新一届国家立法机 关如何立法,成为全社会关注的焦点。截止2003年10月底,十 届全国人大常委会已审议通过了《居民身份证法》、《放射性污 染防治法》、《港口法》、《行政许可法》、《道路交通安全法》等 6部法律。盘点这些新法律的精神脉络,人们不难发现,以人为 本,已经成为我国立法的鲜明特色,立法为民,已经成为立法机 关的首要追求。     

新《律师法》能否解决刑辩“三难”

2008年6月1日起施行的《中华人民共和国律师法》（以下简称新《律师法》），在解决刑事案件辩护中律师“会见难”、“阅卷难”、“取证难”的问题上，在广度和深度上都做了新的规定。新《律师法》不仅在内容方面有所进步。而且在立法上在处理不同的部门法的法律冲突方面也有所突破，起码在立法层面上“会见难”、“阅卷难”、“取证难”的问题获得了一定的解决。但是，我们必须承认，法律如果得不到有效实施，     

食品安全规制的美国法视角

美国联邦政府对于食品安全的法律规制可以上溯到1906年颁布的《纯食品药品法》。百余年来，美国在食品安全掣域经历了由乱到治的漫长历程。如今，一套较为完善的制度已经建立，美国的食品供应也被公认为世界上最安全的食品供应制度之一。     

国家赔偿案件审理中的几个问题

《国家赔偿法》实施已经进入第七个年头，理论界和司法界对《国家赔偿法》都提出了不少批评意见，并提出尽快修改《国家赔偿法》。然而，笔者认为，将我国《国家赔偿法》实施中的问题，全部归昝于立法的不足是不公平的。许多问题是出在对法律的理解和认识，是没有把《国家赔偿法》已经规定的内容认真地落实于司法实践。笔者十分赞成修改《国家赔偿法》，尤其是有关违法归责原则以及与之相关的违法确认、赔偿范围等问题，必须从立法上彻底解决。但是，法律的实施效果，除了立法之外。     

香港律师的起源及发展

我们时常谈及“法治”，但这个法其实源于何处，其发展过程究竟是怎样的，相信不是每个人都清楚。根据《基本法》第 18条的规定，在香港特区实行的法律有《基本法》、香港原有法律、香港特区立法机关制定的法律和透过《基本法》附件三在香港特区实施的全国性法律。在这四类法律中，只有“香港原有法律”一类是从殖民地时代过渡到特区，其他三类都是在 1997年 7月 1日或以后才成为香港法律的来源。 　　“香港原有法律”，根据《基本法》第 8条，是指普通法、衡平法、条例、例属立法和习惯法。它们当中除同《基本法》相抵触或经香港特区立法…     

日本的个人信息保护法制及启示

信息化时代导致的个人信息被恶意利用的事件频发。2005年4月日本《个人信息保护法》经过两年的预备缓冲期后进入了全面实施阶段。该法以OECD的8项原则为基础,借鉴了欧盟的立法模式,在实质上又采纳了美国立法的诸多规定,不论从体例上还是在内容上都是一部比较成熟和完备的法律,值得我国在《个人信息保护法》的制定中予以借鉴和吸收。     

涉外民事法律关系适用法中产品责任法律适用原则的分析

2011年我国正式施行的《中华人民共和国涉外民事关系法律适用法》(以下简称《法律适用法》)中专门规定了涉外产品责任的法律适用,相比之前的立法,无论是我国《民法通则》中关于一般侵权行为的法律适用规定,还是《中华人民共和国国际私法示范法》关于产品责任法律适用的规定都有所发展,更符合国际社会上涉外产品责任法律适用的发展趋势。     

Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published in the Federal Register of May 12, 1998, a proposed rule (63 FR 26129) and a direct final rule (63 FR 26069) to implement amendments to the medical device reporting provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997.     

Medical devices; classification for medical washer and medical washer-disinfector. Final rule

The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA).     

Medical devices; device tracking. Final rule

The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements.     

Medical devices; immunology and microbiology devices; classification of the endotoxin assay. Final rule

The Food and Drug Administration (FDA) is classifying the endotoxin assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.     

FDA modernization act of 1997: guidance on medical device tracking; availability--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance on Medical Device Tracking." This guidance is intended to provide guidelines to manufacturers and distributors about their responsibilities for medical device tracking under the Food, Drug and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act (FDAMA). This guidance addresses what statutory and regulatory tracking requirements have changed and what requirements remain the same under the FDAMA amendments. The agency requests comments on this guidance. Elsewhere, in this issue of the Federal Register, FDA is announcing new orders to manufacturers of devices that were subject to tracking.     

Medical devices; immunology and microbiology devices; classification of the West Nile Virus IgM capture Elisa assay. Final rule

The Food and Drug Administration (FDA) is classifying the West Nile Virus IgM Capture Elisa assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.     

Medical devices; general and plastic surgery devices; classification of the low energy ultrasound wound cleaner. Final rule

The Food and Drug Administration (FDA) is classifying the low energy ultrasound wound cleaner into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the class II device.     

Medical devices; immunology and microbiology devices; classification of the beta-glucan serological assay. Final rule

The Food and Drug Administration (FDA) is classifying the beta-glucan serological reagent device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.     

Radiology devices; classifications for five medical image management devices--FDA. Final rule

The Food and Drug Administration (FDA) is classifying five radiology devices that provide functions related to medical image communication, storage, processing, and display into class I (general controls) or class II (special controls). The medical image storage device and medical image communications device are classified into class I, and they are exempted from the requirement of premarket notification when they do not use irreversible compression. The medical image digitizer, the medical image hardcopy device, and the picture archiving and communications system are classified into class II. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.