Keystone Regulatory Services, LLC

Industry Headlines

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On August 11, 2005, FDA announced submission user fees for FY 2006. 
510(k)’s will cost $3,833; PMA’s, $259,600; 180 day supplements, $55,814; and Real-time supplements, $18,691.  These represent increases of  For more information, visit FDA’s MDUFMA Web Site.

FDA Announces User Fees for FY 2006.

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The January 18, 2005 issue of FDA Digest announced that the Office of Science and Health Coordination has created a Web site devoted to the agency's regulation of products that utilize nanotechnology.  FDA’s position is that the agency regulates products, not technology and that current pre-market and post-market regulatory programs will accommodate developments in the field.  The site links to numerous nanotechnology resources, and it offers slide shows and other presentations on the topic.   Visit http://www.fda.gov/nanotechnology/ for more information.

FDA Issues Guidance on Regulation of Nanotechnology. 

FDA Issues Guidance on Networked Computer Security 

On January 19, 2005, FDA issued “Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software”.  The question-and-answer format document outlines general principles that FDA consider to be applicable to software maintenance actions required to address cybersecurity vulnerabilities for networked medical devices—specifically, those that incorporate off-the-shelf (OTS) software.   Text Version   PDF Version

HIV / Hepatitis Testing Urged for Some Pittsburg Colonoscopy Patients

 

A Pittsburg hospital is urging 200 colonoscopy patients to be tested for HIV and hepatitis.  Technologists noticed that new models of a colonoscope contained an extra lumen which was not routinely being disinfected.  Follow this link for more information.  

FDA Issues Guidance on 510(k) Format

 

On August 12, 2005, CDRH issued a guidance for the format for Traditional and Abbreviated 510(k) Submissions.  Follow this link to obtain a copy of the guidance document.

FDA Issues Guidance on Sharps Protected Devices

 

FDA recently issued a guidance on 510(k) submissions for devices containing sharps protected devices.  This includes not only guards, caps and other protection devices, but also devices designed to eliminate the use of a sharp device such as luer-activated valves.  Click here to see a copy of the recently issued guidance.