Preparing and Submit a Compliant 510(k) Submission
OVERVIEW
Since September 2009, the Centre 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.
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| 510 K Submission Process |
WHY SHOULD YOU ATTEND
This webinar provides an overview of the premarket notification
process and all of the critical and key steps required to ensure you prepare
and submit a well-constructed 510(k). 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. 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.
AREAS COVERED
- 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
LEARNING OBJECTIVES
This webinar will provide valuable assistance and guidance to
medical device and IVD companies involved in any aspect of the 510(k) process.
WHO WILL BENEFIT
- All levels of management and departmental
representatives any anyone who desire a better understanding or a
"refresh" overview of the 510(k) process
- CRO’s
- Regulatory Affairs/RA Specialists
- Clinical Affairs
- Project Leaders
- Quality and Compliance
- Marketing & Sales
- Distributors/Authorized Representatives
- Engineering/Technical Services/Operations
- Consultants
For more detail please click on this below link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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