FDA, Publish Guidance on Animal Studies for Cardiovascular Disease.

Full Text Here

FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies involving cardiovascular devices, including intra-cardiac devices and devices used in the coronary and peripheral vasculature. The animal studies utilized for the assessment of these devices typically provide initial evidence of device safety, their potential performance when used in a living system, and the biologic response that a living system may mount towards the device. We recommend that members of industry and FDA staff who perform or review evaluations of animal studies for cardiovascular devices use this guidance. In this document, the terms “you” and “your” refer to members of industry, also known as “sponsors” or “applicants”. The terms “we,” “us,” “our,” and “Agency” refer to FDA.
The intent of this guidance is to provide a reference of best practices for the approach, conduct, and presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience, while accounting for modern animal care and use strategies. The guidance makes multiple references to pre-existing regulatory requirements involving animal care and use. Of note, FDA maintains a memorandum of understanding (MOU) with the U.S. Department of Agriculture (USDA) and the National Institutes of Health (NIH) that addresses common areas of regulatory practice under which animal studies are to be performed.
We recommend that you use this guidance to develop and present animal study protocols, methods, and reports that support the safety and performance of cardiovascular devices. We intend to use this guidance to review animal study protocols, methods, data, and reports provided in regulatory submissions to demonstrate the safety and performance of cardiovascular devices.

For Access to  a Drug Development or Pre-Clinical Expert Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”