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Preparing and Submitting a Well-Written 510(k): Latest FDA Changes to the Process
- Statutory Requirements and Expectations
- When a 510(k) Is Required and Not Required
- Who is Required to Submit and Who is Exempt
- Device Classification
- Forms Required and to be Used
- Submission Methods: Log-In, Review Process, and the Decision Letter
- Traditional/Special/Abbreviated 510(k) Submissions
- Find and Use the Right Predicates
- Pre-Sub (Q-sub) Approach and FDA Meetings
- Substantial Equivalence: Factors to Consider and Special Considerations
- Requests for Additional Information and How to Respond Effectively to the Reviewer
- Is a New 510(k) Required for a Change or Modification to My Device
- Recent FDA Deficiency Categories for 510(k) Submissions and Pitfalls to Avoid
- Recent FDA Final 510(k) Guidance
- 510(k) Gap Assessment is Crucial Before Submitting
- e-Copy And RTA Policy Requirements
- Mistakes for eCopy and RTA Policy Requirements
- FDA’s Timeline for Receiving Your Submission to Marketing Clearance
- Redefining terms such as Intended Use/Indications for Use, limiting use of predicates, consideration of off-label uses, greater authority to rescind 510(k)s and other changes
- Recommendation for a new subclass of Class 2 products for which clinical studies will be required
- The de novo process could streamline the clearance process
- Obtain latest recommendations and comments from various device trade groups
- What additional costs might device-makers face in light of new regulatory requirements?
- What will the proposed changes mean for the number of devices cleared?
- How will the proposed changes affect so-called "split-predicates" and other considerations?
- What is the regulatory process for implementing the recommendations?
- What can device companies do to prepare for changes?
- 510(k) Frequently Asked Questions by You - Industry
- Latest Trends with 510(k) Submissions and FDA
Overview of the webinar
This webinar provides an overview of the pre-market notification process and all of the critical and key steps required to ensure you prepare and submit a well-constructed 510(k). It also provides an overview of the 510(k) Program including the basics of how to prepare and submit a 510(k) to the FDA and recent changes and trends. There is no 510(k) form, however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission.
Who should attend?
This webinar will provide valuable assistance and guidance to medical device and IVD companies involved in any aspect of the 510(k) process. Employees and personnel who will benefit include:
- All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of the 510(k) process
- CROs
- Regulatory Affairs/RA Specialists
- Clinical Affairs
- Project Leaders
- Quality and Compliance
- Marketing & Sales
- Distributors/Authorized Representatives
- Engineering/Technical Services/Operations
- Consultants
Why should you attend?
Before marketing a device, each submitter (the applicant) must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S.
Since September 2009, the Center for Devices and Radiological Health has been reviewing the operation of the 510(k) program and the way CDRH uses science in the decision-making process. In August 2010, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making each released a preliminary report with a series of recommendations. Overall, industry has provided mostly a positive response but with exceptions. The proposals are more benign than many had feared. No radical change to the current process appears likely. Bottom line, FDA issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.
Faculty - Mr.David Dills
David R. Dills, Senior Consultant, Regulatory Affairs & Compliance NOVUSLIFE
currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA's, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.
He has been directly involved with constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent for clients, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.