{"title":"How to Prepare and Submit a Bullet Proof 510(k), Addressing the Latest FDA Proposed Changes to the Process","description":"\u003cp class=\"Abstract\"\u003eThis one-day course is a primer and overview to the 510(k) premarket notification process. A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to Premarket Approval (PMA). There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the \"New 510(k) Paradigm\" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807, as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eFor more than 30 years, the 510(k) process has consistently done a good job of protecting patients against unsafe products. The process is well designed to assess the safety and effectiveness of low and moderate risk medical devices whose risks are well understood from experience with similar devices. Various industry trade groups and associations are now somewhat concerned that the number and scope of FDA’s recently proposed 510(k) changes could negatively impact the agency’s mission to ensure American patients have timely access to safe and effective medical technologies.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eIn comments submitted to FDA in response to the agency’s August 2010 release of more than 60 proposals to change the 510(k) process, industry has advocated that instead of implementing an extensive list of potentially disruptive proposals, FDA should focus on the proposals the agency has advanced that enjoy broad agreement and consensus. Examples include increased reviewer training, development of specific and relevant guidance documents, and enhancements or improvements to the de novo review pathway, among other suggestions. This course will provide a status update to these proposals, but more importantly, provide direction, guidance, and clarity on preparing for, executing, and submitting your 510(k) application.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Learning Objectives\" border=\"0\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/LearningObjectives.jpg?n=1786\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eDifferentiate between the Traditional, Special, and Abbreviated submissions\u003c\/li\u003e\n\u003cli\u003eDetermine and apply Substantial Equivalence criteria\u003c\/li\u003e\n\u003cli\u003eDetermine who is required to submit the application to FDA\u003c\/li\u003e\n\u003cli\u003eDetermine where to submit the 510(k) and what to expect with the review and approval process\u003c\/li\u003e\n\u003cli\u003eDetermine when it is and when it is not required if you are a device company\u003c\/li\u003e\n\u003cli\u003eList the exemptions to the submission process and special considerations\u003c\/li\u003e\n\u003cli\u003eLocate a \"predicate\" device and go through the content and format of the 510(k)\u003c\/li\u003e\n\u003cli\u003eDescribe the De Novo process and the expectations for possibly marketing a low risk device\u003c\/li\u003e\n\u003cli\u003eDescribe the potential impact of FDA’s proposed changes to the 510(k) process and why manufacturers need to pay attention\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" border=\"0\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/WhoShouldAttend.jpg?n=5464\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eThis course is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and fundamentals for a better understanding on how to prepare and submit your application to ensure regulatory and compliance success. Those who will benefit include professionals in R\u0026amp;D, development, quality assurance and quality control, production, operations, engineering, compliance, regulatory affairs, and all levels of management, including technical and laboratory personnel.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" border=\"0\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/Instructor.jpg?n=4140\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eDavid R. Dills \u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"\/pages\/instructor-biographies\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Course Outline\" border=\"0\" alt=\"Course Outline\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseOutline.jpg?n=2216\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eDay 1: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003e\n\u003cb\u003eI. Introduction and Regulatory Background:\u003c\/b\u003e Review 21 CFR 807 Subpart E, which describes requirements for a 510(k) submission; Current trends with the 510(k) process\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eII. The Process:\u003c\/b\u003e When a 510(k) is required, when it is not, and who is required to submit one; Locating and justifying the predicate; Substantial Equivalence (SE) and demonstration of SE to another legally U.S. marketed device; Prepare and submit a 510(k); List of forms associated with Premarket Notification 510(k) submissions; Decide when to submit a 510(k) for a change to an existing device; Determine what happens and your responsibilities if FDA requires additional information and data\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eIII. Interactive Q\u0026amp;A, Wrap-Up, and Adjourn:\u003c\/b\u003e Q\u0026amp;A with all participants and attendees, including their real-world challenges.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Interactive Activities\" border=\"0\" alt=\"Interactive Activities\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/InteractiveActivities.jpg?n=4477\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eGroup discussion and review of recent 510(k) clearances and proposals, as well as recommendations between FDA and industry.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Registration Fees\" border=\"0\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/RegistrationFees.jpg?n=6142\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eRegistration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for our seminar cancellation policy\" href=\"https:\/\/stage.barnettinternational.com\/EducationalServices\/SeminarFAQs.aspx\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eSpecial rates are available for multiple attendees from the same organization.  Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.\u003c\/p\u003e\n\u003cimg title=\"Accreditation Information\" border=\"0\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/AccreditationInformation.jpg?n=7031\"\u003e\u003cp class=\"Abstract\"\u003e\u003cimg title=\"ACPE Logo\" border=\"0\" alt=\"ACPE Logo\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services_-_Under_Construction\/ACPE%20Logo.JPG\"\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-11-005-L01-P. Released: 4\/11.\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eHold this course at your company!\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eFor more information, contact Naila Ganatra at (215) 413-2471.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/how-to-prepare-and-submit-a-bullet-proof-510k-addressing-the-latest-fda-proposed-changes-to-the-process.oembed","provider":"Barnett International ","version":"1.0","type":"link"}