Assessing FDAs Proposed Changes to the 510(k) Process

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“Description :

This webinar will discuss in detail, the latest FDA’s proposed changes to the premarket notification process, 510(k)

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 and this session will address both sides. The proposals are more benign than many had feared. No radical change to the current process appears likely. Some provisions, however, might not go into effect until the second independent review of the 510(K) program being conducted by the Institute of Medicine comes out in the summer of 2011.

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.

The 510(k) medical device review program is intended to meet two important goals: making available to consumers devices that are safe and effective, and fostering innovation in the medical device industry. In recent years, however, concerns have been raised both within and outside of FDA about whether the current 510(k) program optimally achieves these goals. Some have argued that the 510(k) process allows devices to enter the market without sufficient evidence of safety and effectiveness. Others have argued that a lack of predictability, consistency, and transparency in the process is hindering device development. Industry agrees that regulatory improvements can and should be made to increase efficiency, predictability and consistency of the 510(k) clearance process.

However, we also hear that we are particularly concerned that a number of the proposals on the table may result in a slowdown in innovation, and fewer innovations for the patients who need them. The recommendations are not official guidance yet as they will be open to public comment, and there are in excess of 70 proposed changes that, taken together, could result in a significant disruption to a program that has served patients well for more than 30 years. Following the public comment period CDRH said it will announce which recommendations it will implement as well as the projected timelines for implementation.

Areas Covered in the Session :
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
Learn of possible changes in the de novo process that could streamline the clearance process
Obtain latest recommendations and comments from various device trade groups
How will the expected changes affect device makers?
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””?
What is the regulatory process for implementing the recommendations?
What can device companies do to prepare for upcoming changes?
Industry needs to prepare for these “”likely”” statutory changes in 2013

Who Will Benefit:

This webinar will provide valuable assistance and guidance to device and IVD companies involved in any aspect of the 510(k) process. Employees who will benefit include:
All levels of management and departmental representatives any anyone who desire a better understanding or a “”refresh”” overview of the proposed changes
Regulatory Affairs/RA Specialists
Clinical Affairs
Quality and Compliance
Marketing & Sales
Distributors/Authorized Representatives
Engineering/Technical Services/Operations

David R. Dills

David R. Dills, an independent Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the life sciences and FDA regulated industry, has an extensive regulatory background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory landscape. 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 EU regulatory requirements regarding MDD and CE Mark. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and expertise.

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