White Papers

Overview of Non-Exempt, Significant Risk Medical Device Clinical Studies

Sep 21, 2016 by Lael Pickett, Regulatory Affairs Manager Liz Scheurer, Principal Clinical Research Scientist

The white paper “Overview of U.S. Medical Device Clinical Trials” provided a brief overview of U.S. clinical studies regulations, types of clinical studies and how to determine if an Investigational Device Exemption (IDE) is required. This paper will focus on Non-Exempt clinical studies that present a significant risk to study subjects and require that an IDE be filed and approved by U.S. Food and Drug Administration (FDA) and an Institutional Review Board (IRB) prior to initiating the study.

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A Survey of Changing Regulatory Requirements for Electronic and Electromechanical Medical Devices

Sep 17, 2016 by Dirk Smith, Co-Founder

Medical devices in 2016 continue to benefit from dramatic technology developments across engineering disciplines. Electronic-based devices, in particular, are increasingly employing cutting-edge technologies to meet user demands for fast, multi-function, usable, safe and cost-effective products. As complexity in devices and technology rapidly evolve, regulatory requirements are following suit, with significant and comprehensive updates to requirements and methods for demonstrating safety and efficacy.

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Medical Device Design, Development, and Manufacturing: Considerations when Selecting a Strategic Partner

Aug 21, 2016 by Jim Reed, Vice President, Business Development and Marketing

Historically, the typical approach to medical device start-up development was to build an internal team of employees. This team completed assigned major development milestones, and following this success, management downsized them. Known colloquially as the “Hire, Develop, and Fire Model”, this approach is not only tumultuous and expensive, but it results in a loss of continuity and key core knowledge and know-how. It also presents challenges in managing spiky, episodic workloads with a team of a fixed size.

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Overview of Non-Exempt, Abbreviated Requirements Medical Device Clinical Studies

Aug 15, 2016 by Lael Pickett, Regulatory Affairs Manager Liz Scheurer, Principal Clinical Research Scientist

The white paper “Overview of U.S. Medical Device Clinical Trials” provided a brief overview of US clinical studies regulations, types of clinical studies and how to determine if an Investigational Device Exemption (IDE) is required (Figure 1). This paper will focus on Non-Exempt clinical studies that do not present a significant risk to study subjects and must comply with “abbreviated” FDA regulatory requirements. Non-Exempt/Non-Significant risk (NSR) studies do not require an IDE application be filed with the US Food and Drug Administration (FDA) prior to initiating the study.

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Overview of Exempt Medical Device Clinical Studies

May 15, 2016 by Lael Pickett, Regulatory Affairs Manager Liz Scheurer, Principal Clinical Research Scientist

The white paper “Overview of U.S. Medical Device Clinical Trials” provided a brief overview of US clinical studies regulations, the types of clinical studies and how to determine if an Investigational Device Exemptions (IDE) is required. This paper will focus on studies that are “Exempt” or rather, do not require an IDE application be filed with FDA for pre-study approval.

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Overview of U.S. Medical Device Clinical Trials

Mar 8, 2016 by Liz Scheurer, Principal Clinical Research Scientist Lael Pickett, Regulatory Affairs Manager

Clinical study conduct and design is always a challenge, with patient safety being at the forefront of that challenge. From an initial study concept, a company (“Sponsor”) must assess and implement decisions that will guide the project to the desired end. Is the study focusing on an iteration or small design change to an existing device or software? Is the device, therapy or expected action something novel, and is the study a “first-in-human” with the end result being a determination of “Is it safe and does it work?” This paper will provide a brief overview of US clinical studies regulations, the types of clinical studies and how to determine if an Investigational Device Exemptions (IDE) is required.

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