In vitro medical devices: how businesses can successfully comply with the new European regulation.

The European parliament finally approved the new European in vitro diagnostic regulation (IVDR) on 5 April 2017. This new regulation is shaking up the industry as it has a wider scope than its predecessor, meaning manufacturers of in vitro diagnostic medical devices must revise their compliance strategies exhaustively. In order to help manufacturers begin the process of compliance, this article highlights the principal changes in the regulation, providing a starting point for industry players. Furthermore, the article draws attention to other obstacles to conformity, in particular the shortage of notified bodies, the organisations designated by member states to carry out compliance evaluations. In addition to the commercial stakes for businesses, it is essential to bear in mind the ultimate objective of this overhaul of the regulatory framework, namely, to improve patient safety.

Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.

Scientific evaluation and pricing of medical devices and associated procedures in France.

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.

Legal and regulatory challenges currently facing diabetes treatment providers and related durable medical equipment suppliers.

It has been estimated that 24 million Americans have diabetes, many of whom are Medicare beneficiaries. These individuals carefully monitor their blood glucose levels primarily through the use of in-home blood glucose testing kits. Although the test is relatively simple, the cumulative expense of providing glucose test strips and lancets to patients is ever increasing, both to the Medicare program and to uninsured individuals who must pay out-of-pocket for these testing supplies. This article discusses the diabetes durable medical equipment (DME) coverage under Part B Medicare, the establishment and role of DME Medicare administrative contractors, and national and local coverage requirements for diabetes DME suppliers. This article also discusses the federal government's ongoing concerns regarding the improper billing of diabetes testing supplies. To protect the Medicare Trust Fund, the federal government has contracted with multiple private entities to conduct reviews and audits of questionable Medicare claims. These private sector contractors have conducted unannounced site visits of DME supplier offices, interviewed patients and their families, placed suppliers on prepayment review, and conducted extensive postpayment audits of prior paid Medicare claims. In more egregious administrative cases, Medicare contractors have recommended that problematic providers and/or DME suppliers have their Medicare numbers suspended or, in some instances, revoked. More serious infractions can lead to civil or criminal liability. In the final part of this article, we will examine the future of enforcement efforts by law enforcement and Medicare contractors and the importance of understanding and complying with federal laws when ordering and supplying diabetes testing strips and lancets.

Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy.

Through its premarket regulation of medical devices, FDA aims to secure device safety and effectiveness while allowing for device innovation. However, these competing objectives have proven too difficult to reconcile. Premarket regulations not only impose a substantial burden on device manufacturers, patients, and FDA itself, they also threaten the advancement of new device technologies. This Article provides an in-depth look at the costs of FDA's current regulatory system, and suggests that these costs ultimately outweigh the system's benefits. Therefore, it proposes that the U.S. consider a new approach to device regulation--one that focuses primarily on postmarket surveillance, and allows end-users, such as health care providers and professional medical organizations, to take a more prominent role.