Stay up-to-date on Medical Device Clinical Trials http://www.clinicaldevice.com en-us http://clinicaldevice.typepad.com/cdg_e_conferences/2010/12/finding-5.html?source=MDDI http://clinicaldevice.typepad.com/cdg_e_conferences/2010/12/finding-5.html?source=MDDI In August 2010, CDRH's 510(k) Working Group published a preliminary report consisting of more than 60 recommendations grouped under seven findings aimed at improving the Center's effectiveness in implementing its missions. Will the recommendations work? Do they comprise a forward-thinking strategic plan for the device industry? You'll find CDG's summation of Findings 1 through 4 in previous posts and broadcasts, along with our opinions of their worth. Herein you'll find our thoughts on Finding 5. If you wish to comment, please do so at our blog. Read more... http://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed http://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed The 2010 CRA Handbook is finally here! We delayed production until we were sure that the ISO/FDIS 14155 "Clinical investigations for medical devices—good clinical practices" (2010) was definite. So here you have it: the best and the original field guide to medical device clinical trials, brought to you from Clinical Device Group. If you have used our handbook before, you'll be pleased to know that we are offering it again as either a spiral-bound paper edition (designed to lie flat, fit compactly in your briefcase, and lend itself to field notes) OR the electronic version (designed to load to your laptop, be fully searchable as a pdf document, and annotatable if you have Acrobat Writer). Read more... http://www.clinicaldevice.com/training/10-04-15_ISO-ClinicalEvaluations.htm?source=rssfeed http://www.clinicaldevice.com/training/10-04-15_ISO-ClinicalEvaluations.htm?source=rssfeed Today I want to discuss the role that clinical evaluations will play in justifying the implementation and design of device clinical trials once the 2010 ISO/DIS 14155 "Clinical investigations for medical devices in human subjects--good clinical practices" becomes a published standard. Over the past several months I've written extensively about clinical evaluation reports, but always within the context of obtaining or maintaining a CE Mark and quality system certification. Read more... http://www.clinicaldevice.com/mall/eConferences.aspx?source=rssfeed http://www.clinicaldevice.com/mall/eConferences.aspx?source=rssfeed In this e-conference you will learn how to apply risk management concepts to the clinical research process. You will learn how risk management allows a manufacturer to make more objective and informed decisions about when to initiate, suspend, restart, modify or stop a clinical study. And you will learn how specific risk management tools can assist in these clinical study decisions. Read more... http://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed http://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed FDA held a public meeting on 18 February 2010 to discuss issues and actions that can be taken to revise, improve, and strengthen the 510(k) process. If you missed it, you should obtain the audio recording, transcript, and slides from Clinical Device Group. Read more... http://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed http://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed The 2007 amendment to the European Medical Device Directive comes into force in March 2010, and it requires a clinical evaluation report (CE Report) be conducted as part of the process to market a device. Since Notified Bodies (NB) will review the results of the evaluation, it is important that the clinical evaluation is conducted correctly and robustly. Take this e-conference and learn what are the NB expectations for these reports. Read more... http://clinicaldevice.typepad.com/cdg_e_conferences/design-control-of-investigational-devices-complaints-to-be-monitorable-under-iso-14155-2010-.html http://clinicaldevice.typepad.com/cdg_e_conferences/design-control-of-investigational-devices-complaints-to-be-monitorable-under-iso-14155-2010-.html The new ISO 14155 "Clinical investigation of medical devices in human subjects - good clinical practices" will be published in 2010. It is likely to be recognized by FDA, which will give it tremendous standing within the US, as well as EU and Japan. The standard will alter the foundation of every clinical trial conducted. It makes the need for investigational device design control paramount and its deficiency monitorable and reportable within the adverse event reporting system. Read more... http://www.surveymonkey.com/s/DCVG3MG?source=rssfeed http://www.surveymonkey.com/s/DCVG3MG?source=rssfeed We've put the Working Group survey into SurveyMonkey so that you can take it yourself, benchmark your answers against your colleagues', and then compare your answers to Center staff. It's useful and informative to see if your understanding of the 510(k) clearance process is the same as the agency's. When you've finished, give us your email address to receive OnDemand access to "Surviving Medical Device Recalls" presented by the Center's Bioresearch Monitoring staff. Read more... http://clinicaldevice.typepad.com/cdg_e_conferences/2010/11/findings-1-2.html?source=rssfeed http://clinicaldevice.typepad.com/cdg_e_conferences/2010/11/findings-1-2.html?source=rssfeed In February 2010, CDRH held a two-day "town hall" meeting called Strengthening the Center in which they presented several of their concerns and invited selected industry and user representatives to present theirs. This was followed by two internal surveys—one from the 510(k) Working Group and the second from the Task Force on Utilization of Science in Regulatory Decision Making—published in August 2010. Read more... http://www.clinicaldevice.com/mall/Workshops.aspx?source=rssfeed http://www.clinicaldevice.com/mall/Workshops.aspx?source=rssfeed The objective of the workshop is to learn the basics of European regulations and how to determine if you need a clinical study in order to get market your device. This is an introductory workshop and focuses on European regulations. A complimentary workshop focusing on US regulations is also available. Register for both workshops and get $100 off. Enter the coupon code SUMMER at check-out. Read more... http://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed http://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed You are probably already aware of the new requirements for Clinical Evaluation Reports if you sell medical devices in Europe. Coming into force in 2010, every medical device--including Class I and Class IIa- -will be required to have a Clinical Evaluation Report in its technical file. The Global Harmonization Task Force guidance explains how to do a clinical evaluation that will conform to the new MDD standards. Take this e-conference, and see how to conduct a step-by- step clinical evaluation according to the GHTF guidance. Read more... http://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed http://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed Investigators are expected to make certain contributions to clinical investigations. But there are also many duties they typically take on that are not identified in any regulation or guidance. Some are standard practice, others are bad ideas. In this session you will learn the subtleties of investigator responsibilities, learn how sponsors can help assure investigator compliance, and see how the States compare with international expectations. Read more... http://clinicaldevice.typepad.com/cdg_e_conferences/2010/11/fda_working_group_findings_3_n_4a.html?source=rssfeed http://clinicaldevice.typepad.com/cdg_e_conferences/2010/11/fda_working_group_findings_3_n_4a.html?source=rssfeedThe Center for Devices and Regulatory Health has two important missions: 1) to protect the public health and 2) to foster medical device innovation. Their difficult job is to keep these missions in balance, never compromising one in favor of the other. http://www.clinicaldevice.com/09-09-14_Clinical_Evaluation_Report_Whitepaper.htm?source=rssfeed http://www.clinicaldevice.com/09-09-14_Clinical_Evaluation_Report_Whitepaper.htm?source=rssfeed You are probably already aware of the new requirements for Clinical Evaluation Reports if you sell medical devices in Europe. Coming into force in 2010, every medical device--including Class I and Class IIa- -will be required to have a Clinical Evaluation Report in it's technical file. Read more... http://www.clinicaldevice.com/mall/ProductPage.aspx#AEPad?source=rssfeed http://www.clinicaldevice.com/mall/ProductPage.aspx#AEPad?source=rssfeed The Adverse Event note pad is a graphical way for study site staff to categorize adverse events. Starting at the center, they choose the characteristics in a pie-wedge that best describe the event. The outer ring identifies the event by type. ISO definitions, accepted by FDA, are provided on the right. The tool helps study staff think their way through to the reporting requirements described in the protocol. Read more... http://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed http://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed It is complicated to keep it straight in your head, but easy with the pocket-sized, laminated, FDA and ISO consistent Adverse Event Wheel. This easy AE look-up tool takes you or your study coordinators to uniform first-cut categorizations of adverse events so they are reported on time, just as defined in your protocol. http://www.clinicaldevice.com/training/09-11-06_OnDemandSpecial.htm?source=rssfeed http://www.clinicaldevice.com/training/09-11-06_OnDemandSpecial.htm?source=rssfeed Our high-level workshops and e-conferences are available OnDemand so you can view the presentations on your schedule, when you need them. OnDemand workshops and e-conferencesalso provide the opportunity to earn continuing education credits/contact hours (CEUs) at your convenience.