The majority of medical devices commercialized in the United States require a 510(k) submission, which is used to demonstrate that the medical device is at least as safe and effective, or substantially equivalent, to a predicate device, meaning a device that is legally marketed and is not subject to a PMA. Many companies planning to introduce a medical device to the US market need to submit an application to the FDA called a 510(k).
View this email in your browser | Unsubscribe from future mailings 2-day In-person Seminar on Prepare and Submit 510(k) Premarket Notification Submissions for Success Course "Prepare and Submit 510(k) Premarket Notification Submissions for Success" has been pre-approved by RAPS as Register Now eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Date & Time: Instructor Profile: September 06th and 07th 8 AM to 5 PM EDT 2012 David R. Dills Industry Regulatory & Duration: 2 Days Instructor: David R. Dills Compliance Consultant, Location: Minneapolis, Price : $1295.00 (for one participant) David R. Dills, an independent Minnesota Regulatory & Compliance Consultant Register for 4 Participants to Get 1 Free Pass with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive Overview: regulatory and compliance The majority of medical devices commercialized in the United States background with Class I/II/III and require a 510(k) submission, which is used to demonstrate that the IVD devices and managing and medical device is at least as safe and effective, or substantially handling activities within the global equivalent, to a predicate device, meaning a device that is legally regulatory and compliance marketed and is not subject to a PMA. Many companies planning to landscape. He manages quality, regulatory and compliance projects introduce a medical device to the US market need to submit an with multiple competing priorities application to the FDA called a 510(k). The 510(k) is needed for some having a direct impact on site Class I devices, not all since some are exempt, and nearly all Class II operations and commercial devices and a very small number of Class III devices. This seminar opportunities and develops will outline all of the critical and key steps involved and provide a strategies for governmental approval detailed overview of how the FDA 510(k) process works. to introduce new products to market, provides guidance and direction on The Center for Devices and Radiological Health (CDRH) within the FDA regulatory and compliance requirements and prepares/reviews receives more than 4,000 (approximately) 510(k) submissions worldwide annually. Within CDRH, the Office of Device Evaluation (ODE) and the submissions/dossiers/technical files Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) are and addresses requirements in the responsible for processing and reviewing 510(k)’s. Branches within EU, Pacific Rim and The Americas these offices are organized according to medical scientific disciplines regarding all aspects of device and are staffed by FDA reviewers. These reviewers, who are commercialization and especially biomedical engineers, physicians, microbiologists, chemists, and FDA activities. Background other professionals, will determine whether a new medical device is encompasses broad capabilities in quality systems, validation, substantially equivalent and can be marketed in the United States. regulatory affairs, GxP compliance, Typically, this FDA decision is made within 90 days. auditing, interfacing with the regulatory agencies, managing Course Outline: enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR’s Course Outline: Day 1: and demonstrates credible experience to maximize business Lecture 1: performance in the devices arena. He strives to optimize business performance through proactive l Introductions/Background strategies to mitigate compliance l Current trends with the 510(k) process exposure by providing strategic and l Marketing clearance from CDRH tactical solutions that facilitate the l Who is Required to Submit a 510(k) achievement of regulatory l When a 510(k) is Not Required milestones. David has been l Preamendment Devices previously affiliated with well-known l Locating and justifying the Predicate device manufacturers and service l Substantial Equivalence and demonstration of SE to another providers, including a well-known CRO and has served in various legally U.S. marketed device quality, regulatory and compliance l How to Prepare Submissions and Walk Through the Entire management and advisory capacities Process with increasing responsibilities. l 510(k) Submission Methods David is an accomplished industry l List of forms associated with Premarket Notification 510(k) speaker and author of technical and submissions compliance related topics published l Deciding When to Submit a 510(k) for a Change to an Existing in industry journals. Please refer to Device - is a new 510(k) required for a modification to your his profile provided herein for additional information about his device? background. ...more l What happens if FDA requires additional information and data and your responsibilities l Performing a 510(k) assessment to identify or confirm the most appropriate predicate device(s) and ensuring that you have Suggest a Topic More Webinars addressed potential FDA triggers and red-flags Your Necessity is our Priority l Developing and preparing a written argument for “substantial equivalence” that will compare your device to a predicate device(s). l Identifying any applicable FDA Guidance Documents l Debrief Course Outline: Day 2: Lecture 2: l Third-Party Review Program l Communicating directly with FDA staff to identify any special requirements that may impact the review of your 510(k), if necessary l Preparing and submitting the 510(k) document to the FDA l FDA requests for more information, clarification and requests for more data: how to handle strategically l Coordinating any communications and negotiations with the FDA reviewer, and preparing responses to FDA questions, if necessary l Log-In Procedure to check on status l Reviewer Assignment l Review Fees l Decision Letter Issued l Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry l Discussion Points and FDA Trends l Execute an effective path to approval for future submissions l Analyze the benefits/risks for informed decision-making and interpreting the regulatory precedents and new legislation with the 510(k) process l 510(k) Frequently Asked Questions, Q&A, Wrap-Up and Adjourn l Attendees and participants should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session Click here to register for this seminar Who Will Benefit: l Professionals in R&D l Quality Assurance and quality control l Production l Operations l Engineering l Compliance l Regulatory Affairs and all Levels of Management It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. 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