Market introduction of innovative high risk medical devices: towards a recast of the directive concerning medical devices

The European Conformity (CE) marking grants early market introduction to innovative high risk medical devices based on safety and device performance only, without any requirement to demonstrate clinical efficacy or effectiveness. Hence healthcare providers, patients and payers are informed neither about the added clinical value compared to an existing medical device nor about the risks incurred by using such innovations. In addition there is a lack of coherence and uniformity of approach in the assessment of high risk medical devices. These gaps may put the health and safety of patients in danger. The European Commission, in concert with Competent Authorities, industry, Notified Bodies, and other stakeholders, is working on a "recast" of the directives regulating medical devices. This article identifies and discusses the critical points of the pre-market clinical evaluation of innovative high-risk medical devices in the European legal framework and compares it with the USA.     

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).     

Coexistence, conflict, and cooperation: public policies toward medical devices

Medical devices include thousands of products, many of which have greatly contributed to the quality of health care. As devices have proliferated, so have public policies that affect them. The federal government intervened to promote three fundamental values: safety by federal regulation, innovation through federal funding of research and development, and access by providing services under Medicare. The policies generally coexisted without conflict. However, two recent developments--the advent of cost containment and the expansion of the tort liability system--present a potentially disruptive influence on these policies, and threaten to undermine the values they serve. Because cost restraints are inevitable and the tort system provides consumer protection, the challenge for policymakers is to reconcile them with the values of safety, innovation, and access. The proposals presented here seek to promote coordination to protect those values without imposing unacceptable costs on the health care system.     

Recovering fraudulent claims for Australian federal expenditure on pharmaceuticals and medical devices

The Australian Federal Government expends increasingly large amounts of money on pharmaceuticals and medical devices. It is likely, given government experience in other jurisdictions, that a significant proportion of this expenditure is paid as a result of fraudulent claims presented by corporations. In the United States, legislation such as the False Claims Act 1986 (US), the Fraud Enforcement and Recovery Act 2009 (US), the Stark (Physician Self-Referral) Statute 1995 (US), the Anti-Kickback Statute 1972 (US), the Food, Drug and Cosmetic Act 1938 (US), the Social Security Act 1965 (US), and the Patient Protection and Affordable Care Act 2010 (US) has created systematic processes allowing the United States Federal Government to recover billions of dollars in fraudulently made claims in the health and procurement areas. The crucial component involves the creation of financial incentives for information about fraud to be revealed from within the corporate sector to the appropriate state officials. This article explores the opportunities for creating a similar system in Australia in the health care setting.     

Natural rubber-containing medical devices; user labeling--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule requiring labeling statements on medical devices, including device packaging containing natural rubber that contacts humans. The rule requires labeling of medical devices containing natural rubber latex that contacts humans to state: "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."; labeling of medical devices containing dry natural rubber that contacts humans to state: "This Product Contains Dry Natural Rubber."; labeling of medical devices containing natural rubber latex in their packaging that contacts humans to state: "Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."; labeling of medical devices containing dry natural rubber in their packaging that contacts humans to state: "The Packaging of This Product Contains Dry Natural Rubber."; and that the claim of hypoallergenicity be removed from the labeling of medical devices that contain natural rubber. These requirements are being established in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber.     

Medical devices; medical device reporting. Direct final rule

The Food and Drug Administration (FDA or we) is amending its regulation governing reporting of deaths, serious injuries, and certain malfunctions related to medical devices. We are revising the regulation into plain language to make the regulation easier to understand, and we are making technical corrections. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule.     

Patenting medical devices: the economic implications of ethically motivated reform

This article explores whether the current patent system strikes the optimal balance between providing incentives to inventors to bring new medical devices to the marketplace and promoting public health by ensuring that these medical devices are widely available at a reasonable price. After providing an overview of the relationship of patent law to medical devices, the author explains how ethical and economic considerations suggest the need for an alternative patent system for medical devices and notes the difficulties with this proposal. The author concludes that a combination of alternatives to the current system most equitably account for the interests and needs of both healthcare device consumers and producers.     

The regulation of cognitive enhancement devices: extending the medical model

This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions.     

Obstetric and gynecologic devices; reclassification and classification of medical devices used for in vitro fertilization and related assisted reproduction procedures--FDA. Final rule

The Food and Drug Administration (FDA) is announcing that it is reclassifying instrumentation intended for use in in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures, including but not limited to gamete intrafallopian transfer (GIFT), embryo transfer (ET), and intracytoplasmic sperm injection (ICSI), from class III (premarket approval) to class II (special controls). FDA is also reclassifying assisted reproduction microscopes and microscope accessories from class III to class I. This reclassification is on the Secretary of the Department of Health and Human Services' (the Secretary's) own initiative based on new information. Accordingly, the order is being codified in the Code of Federal Regulations. Upon the effective date, this Federal Register document may be cited in the absence of an existing predicate device which would be used to support substantial equivalence. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance entitled "Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k)."     

Natural rubber-containing medical devices; user labelling--FDA. Final rule; interpretation

The Food and Drug Administration (FDA) is providing notice that it does not intend to apply to combination products currently regulated under human drug or biologic labeling provisions its September 30, 1997, final rule requiring certain labeling statements for all medical devices that contain or have packaging that contains natural rubber that contacts humans. FDA is taking this action, in part, in response to a citizen petition and other communications from industry that the agency has received since the publication of the final rule. FDA intends to initiate a proceeding to propose natural rubber labeling requirements for drugs and biologics, including combination products that are currently regulated under drug and biologic labeling provisions. Such a proceeding may include a combination of rulemaking and guidance and will offer opportunity for public comment.     

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.     

Medical devices; medical device reporting; baseline reports. Direct final rule

The Food and Drug Administration (FDA) is amending its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports. The removal of this requirement will eliminate unnecessary duplication and reduce the manufacturer's reporting burden. FDA is amending the regulation in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.     

虚假广告的成因及对策探析

近些年,虚假广告被大量发布,严重侵害了消费者的合法权益。道德缺失、法制不健全、监管不力是虚假广告泛滥的主要因素。应加强全社会道德法制教育,完善相关立法,加强广告监管制度及责任追究制度,规范广告市场,保护消费者合法权益。