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This Two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). 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 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 release in August 2010 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, such as: increased reviewer training, development of specific and relevant guidance documents, and enhancements or improvements to the de novo review pathway, among other suggestions. This 1-day primer and course will provide an update to these proposals as appropriate and where we stand but more importantly, provide direction, guidance and clarity on preparing for, executing and submitting your 510(k) application.
- Know the differences between the Traditional, Special and Abbreviated submissions
- Understand Substantial Equivalence and how it is applied
- Who is required to submit the application to FDA
- Where to submit the 510(k) and what to expect with the review and approval process
- When it is and is not required if you are a device company
- Exemptions to the submission process and special considerations
- How to locate a "predicate" device and go through the content and format of the 510(k)
- Understand the De Novo process and the expectations for possibly marketing a low risk device
- Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention
Day 1 – Agenda
Lecture 1: Introduction and Regulatory Background
- There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission.
- Current trends with the 510(k) process.
Lecture 2: The Process
- Who is Required to Submit a 510(k)
- When a 510(k) is Not Required
- When a 510(k) is Required
- Locating and justifying the Predicate
- Substantial Equivalence and demonstration of SE to another legally U.S. marketed device
- How to Prepare Submissions
- 510(k) Submission Methods
- List of forms associated with Premarket Notification 510(k) submissions
- Deciding When to Submit a 510(k) for a Change to an Existing Device
- What happens if FDA requires additional information and data and your responsibilities
Day 2 – Agenda
Lecture 3: Interactive Q&A, Wrap-Up and Adjourn
- Q&A with all participants and attendees
- Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry
- Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting use of predicates, greater authority to rescind 510(k)s, etc.
- 510(k) Frequently Asked Questions
- 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
Who Will Benefit:
- Vitro Diagnostic Manufacturers
- R&D Professionals
- Quality Assurance and Quality Control Personnel
- Medical compliance and Regulatory Affairs Professional
- Laboratory Personnel
- Production, Operations, Engineering Professional
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GXP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's.
DATE, VENUE & PRICE:
1. Location: Philadelphia |November 7th & 8th, 2013|8:30Am to 5 Pm
Venue: DoubleTree by Hilton Hotel Philadelphia Center City
Register now and save $200. (Early Bird)
Until October 10, Early Bird Price: $1,295.00
from October 11 to November 05, Regular Price: $1,495.00
2. Location: San Francisco | December 12th & 13th, 2013| 8:30 AM to 5 PM
Venue: DoubleTree by Hilton Hotel San Francisco Airport
Register now and save $200. (Early Bird)
Until October 25, Early Bird Price: $1,295.00
From October 26 to December 10, Regular Price: $1,495.00
Toll free: 1800 447 9407
Fax: 302 288 6884
LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php
Event Link - http://bit.ly/16mvcOu
Net Zealous LLC,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
If the 2-day In-person Seminar On How To Prepare And Submit A Bullet Proof 510(k) And Latest FDA Proposed Changes To The Process At Philadelphia, PA is important to your business, act now and make the appropriate connections. See the contact information below.
|Conference/Event Dates:||11/07/2013 - 11/08/2013|
|Other Industries:||Pharmaceutical, Professional Healthcare|
|Audience:||Vitro Diagnostic Manufacturers
Quality Assurance and Quality Control Personnel
Medical compliance and Regulatory Affairs Professional
Production, Operations, Engineering Professional
|Venue:||DoubleTree by Hilton Hotel Philadelphia Center City|
|Venue Phone:||(800) 447-9407|
|Venue Type:||Indoor - Hotel|
|Booth Size||Booth Cost||Available Amenities|
|Call for information.||Electricity:||n/a|
|Marketing Vehicles Allowed:||Call|
|Other Booth Sizes Available: n/a|
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