Compliance In Focus

Gamification is defined as “the process of turning an activity or task into a game or something resembling a game.” This concept has been leveraged in the fields of education and marketing to create engagement with a topic or product by using game playing techniques such as point scoring, achievement badges, or virtual currency.

The Center for Devices and Radiological Health (CDRH) recently released an update on its 2014-2015 Strategic Priorities. This document summarizes the areas that CDRH is focusing on to ensure patients in the US have access to high-quality, safe, and effective medical devices. The current strategic priorities are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection, and to provide excellent customer service.

There has been a recent trend in clinical research toward the use of central Institutional Review Boards (IRBs) or Ethics Committees (ECs) for multi-center trials. 21 CFR Part 56.114 outlines the following on cooperative research:

What is a guidance document and how should they be used? A guidance document represents the FDA’s current thinking on a topic. Per FDA’s website, guidance documents “do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternate approach if the approach satisfies the requirements of the applicable statues and regulations.” Guidance documents usually discuss FDA’s interpretation of their policy on a regulatory issue.

Recently, a clinical site received a call from an inspector on a Thursday notifying the site of a not-for-cause inspection the following Monday. This was a short gap of time between the notification and actual audit conduct. How can sites make sure they are ready if an inspector calls today?

Sponsor-Investigators are uniquely dedicated and invested in clinical research. In a previous blog post, IMARC described how Sponsor-Investigators have to wear two hats and follow two sets of regulations.

In August, the FDA issued the final guidance document on Evaluation of Sex-Specific Data in Medical Device Clinical Studies. The intention of this guidance document is to improve the quality and consistency of available data regarding device performance in both sexes for devices that require clinical information in support of a marketing submission or post-approval/post-market surveillance submissions. The primary limitation on devices involves devices that are sex-specific; for instance, urology devices that are designed to be single-sex only.