How to Prepare and Submit a Bullet Proof 510(k), Addressing the Latest FDA Proposed Changes to the Process

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This 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.

For 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.

In 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.

Learning Objectives

  • Differentiate between the Traditional, Special, and Abbreviated submissions
  • Determine and apply Substantial Equivalence criteria
  • Determine who is required to submit the application to FDA
  • Determine where to submit the 510(k) and what to expect with the review and approval process
  • Determine when it is and when it is not required if you are a device company
  • List the exemptions to the submission process and special considerations
  • Locate a "predicate" device and go through the content and format of the 510(k)
  • Describe the De Novo process and the expectations for possibly marketing a low risk device
  • Describe the potential impact of FDA’s proposed changes to the 510(k) process and why manufacturers need to pay attention
Who Should Attend

  • This 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&D, development, quality assurance and quality control, production, operations, engineering, compliance, regulatory affairs, and all levels of management, including technical and laboratory personnel.

The course will be led by one of the following instructors:

David R. Dills 

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Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

  • I. Introduction and Regulatory Background: Review 21 CFR 807 Subpart E, which describes requirements for a 510(k) submission; Current trends with the 510(k) process
  • II. The Process: 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
  • III. Interactive Q&A, Wrap-Up, and Adjourn: Q&A with all participants and attendees, including their real-world challenges.

Interactive Activities

Group discussion and review of recent 510(k) clearances and proposals, as well as recommendations between FDA and industry.

Registration Fees

Registration 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.

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Special 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.

Accreditation Information

ACPE LogoBarnett 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.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.


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