Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct.

As medical device development becomes increasingly global, the opportunities and potential advantages offered by international clinical trial and regulatory approval strategies are also growing. In particular, medical device clinical trials involving sites in both the United States and Japan and intended to support marketing in both countries may warrant particular consideration, given the similarities in their regulatory systems, patients and clinical practice patterns, and market sizes. Since 2003, the US-Japan Harmonization By Doing (HBD) initiative has been focused on identifying and addressing clinical and regulatory barriers to medical devices access in both countries via collaboration between governmental, academic, and industry stakeholders. Through the efforts of HBD participants, US-Japanese clinical trials have been conducted and the resulting data have supported regulatory approval for marketing in both countries. Based on these experiences, this paper outlines some of the key factors to consider when developing a global clinical trial involving US and Japanese participation. These considerations include the mechanisms for consultation with regulatory authorities on clinical trial strategies, the regulatory framework for clinical trial notification and approval, recruitment and conduct of clinical sites, and lessons learned from specific US-Japanese clinical trial experiences. The goal of this paper is to promote global access to promising medical technologies by assisting potential clinical trial sponsors in understanding when an international strategy may be appropriate and successful.

Correction to: A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions.

In the original article Fig. 3 is not displayed correctly. The corrected figure follows.

A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions.

BACKGROUND: The postmarket surveillance system plays a vital role in managing residual risks and identifying safety signals in real-world clinical practice. The Food and Drug Administration (FDA) can order postmarket surveillance studies when safety concerns are raised. We conducted a thorough investigation of device characteristics, study statuses, and the outcomes of US postmarket surveillance studies. METHODS: As of April 2017, we identified 338 orders, corresponding to 394 studies using the FDA database. Additional searches were conducted to identify safety issues or reasons for orders. RESULTS: Completed and active studies were limited. Fifteen of the 394 (3.8%) studies have been completed, and one study resulted in a recommendation of a labeling change. Forty-one (10.4%) studies were active. The majority of the studies (84.3%) were inactive. Three hundred fourteen (93%) orders were issued for implantable devices. The devices for use in women accounted for 144 (43%) orders. The mean from the first premarket approval or 510(k) clearance to 522 orders were 2968 days (n = 9) and 3320 days (n = 326), respectively, and the longest lag was 13,186 days. CONCLUSIONS: Our investigation highlighted that postmarket surveillance study orders resulted in the weeding out of many of the subject medical devices. There were little clinical data produced under the program. Timely and transparent feedback from the postmarket studies are critical for informed decisions by patients and medical practitioners and in expediting patient access to innovative or advanced medical devices.