is being presented by David Rothkopf, President, of MEDIcept and airs on Tuesday, March 13th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Many companies make subtle changes to their devices over time. However, those subtle changes can add up to the point where the current design no longer matches the product deemed safe and effective by the FDA. Whether you just received clearance for your product or it was last cleared in the last century, the FDA has stepped up enforcement on modifications to devices without notification. During site investigations, the FDA is looking at design changes and reviewing all the changes between now and when you last received a 510(k) clearance.
In July 2011 the FDA released a draft guidance document on 510(k) device modification and when to submit a new 510(k) for an existing device. This document reflects the current thinking of the FDA, and will replace the present guidance released in 1997. Are you ready? Do you know the configuration of your product when it was last cleared? Those “letter to file” changes might no longer be acceptable. This audio conference presentation reviews the new guidance document, looks at how to perform a design gap analysis on a device, and discusses what to do when you realize you probably should submit a new 510(k).
Showing posts with label 510k. Show all posts
Showing posts with label 510k. Show all posts
Thursday, March 1, 2012
Monday, January 30, 2012
The De Novo Petition – Is There Hope at FDA for Lower Risk, Innovative Devices?
is being presented by Michael A. Swit, Principal, with Law Offices of Michael A. Swit and airs on Wednesday, February 15th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).
In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.
In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.
The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).
In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.
In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.
Friday, January 13, 2012
Preparing for 2012: Regulatory Update for Device & Diagnostic Companies
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Tuesday, January 31st, 2012. For more details, or to register please visit our site at www.fxconferences.com
2011 was quite a year for publishing proposed major changes to the regulatory framework for medical device and diagnostics manufacturers. It is likely that more certainty will be introduced during 2012 as to what the changes will be and how they will affect MD&D companies. The major topics include the 510K process in the US, the planned recast of the Medical Device Directives in the EU, potential changes to the informed consent process for sample collection in the US, planned changes to the monitoring guidance in the US, and the changes to the ISO 14155 standard issued in 2011.
In this audio conference, our speaker reviews the changes or proposed changes to the regulatory framework, discusses the implications for MD&D companies, and describe how best to plan for future changes. The presentation also provides pointers on when the changes currently in draft form are likely to be implemented. This audio conference is intended to summarize the 2011 regulatory landscape for MD&D companies, and help them prepare for 2012 and beyond.
2011 was quite a year for publishing proposed major changes to the regulatory framework for medical device and diagnostics manufacturers. It is likely that more certainty will be introduced during 2012 as to what the changes will be and how they will affect MD&D companies. The major topics include the 510K process in the US, the planned recast of the Medical Device Directives in the EU, potential changes to the informed consent process for sample collection in the US, planned changes to the monitoring guidance in the US, and the changes to the ISO 14155 standard issued in 2011.
In this audio conference, our speaker reviews the changes or proposed changes to the regulatory framework, discusses the implications for MD&D companies, and describe how best to plan for future changes. The presentation also provides pointers on when the changes currently in draft form are likely to be implemented. This audio conference is intended to summarize the 2011 regulatory landscape for MD&D companies, and help them prepare for 2012 and beyond.
Monday, November 21, 2011
Best Approaches for Your 510(k) Submission
is being presented by F. David Rothkopf, President, of MEDIcept and airs on Tuesday, November 22nd, 2011. For more details or to register, please visit our site at www.fxconferences.com
There has been a lot of news lately – both positive and negative – about the FDA’s 510(k) medical device clearance process. FDA, Congress, and many third parties are reviewing the process for efficiency and effectiveness. The FDA has hired many new reviewers, but training has been slow. They have released new guidance documents relating to 510(k) submission components, but they are radically different than the previous interpretation of the requirements.
The result of all this change has been that review times have increased by 65 percent since 2005, and the number of reject decisions – not substantially equivalent, NSE determinations – increased from a historic level of 3.5 percent to 8 percent of 510(k) submissions during the 2010 fiscal year.
This is the new normal. Even if you sent in a submission two years ago, it might not be acceptable now. So what exactly does FDA want to see in your 510(k) submission, and how do medical device manufacturers cope with this new reality?
There has been a lot of news lately – both positive and negative – about the FDA’s 510(k) medical device clearance process. FDA, Congress, and many third parties are reviewing the process for efficiency and effectiveness. The FDA has hired many new reviewers, but training has been slow. They have released new guidance documents relating to 510(k) submission components, but they are radically different than the previous interpretation of the requirements.
The result of all this change has been that review times have increased by 65 percent since 2005, and the number of reject decisions – not substantially equivalent, NSE determinations – increased from a historic level of 3.5 percent to 8 percent of 510(k) submissions during the 2010 fiscal year.
This is the new normal. Even if you sent in a submission two years ago, it might not be acceptable now. So what exactly does FDA want to see in your 510(k) submission, and how do medical device manufacturers cope with this new reality?
Tuesday, November 15, 2011
Dealing With the New FDA: How the Focus is Changing
is being presented by Stephen D. Terman, Principal, Olsson Frank Weeda Terman Matz PC and airs on Thursday, Decemeber 1st, 2011. For more details, or to register please visit our site at www.fxconferences.com
Marketing a medical device in the United States requires complying with myriad Food and Drug Administration (FDA) regulations. Implementing an effective regulatory strategy can be complicated, time consuming and costly – manufacturers need to get it right the first time. For many years, dealing with FDA was fairly predictable. However, these days it is not 'business as usual' at FDA – change is in the air. FDA is under new, ever-changing management and has significantly increased the number of field inspectors. Enforcement actions are on the rise, both domestic and international. FDA has also pledged to “revamp” the 510(k) system. So many changes (and more sure to come) – how do manufacturers deal with the uncertainty?
This audio conference presentation discusses the ongoing changes within FDA, and what that means in terms of enforcement focus. Our speaker reviews the compliance mistakes made most often by device manufacturers, and provides pointers on how best to interact with FDA.
Marketing a medical device in the United States requires complying with myriad Food and Drug Administration (FDA) regulations. Implementing an effective regulatory strategy can be complicated, time consuming and costly – manufacturers need to get it right the first time. For many years, dealing with FDA was fairly predictable. However, these days it is not 'business as usual' at FDA – change is in the air. FDA is under new, ever-changing management and has significantly increased the number of field inspectors. Enforcement actions are on the rise, both domestic and international. FDA has also pledged to “revamp” the 510(k) system. So many changes (and more sure to come) – how do manufacturers deal with the uncertainty?
This audio conference presentation discusses the ongoing changes within FDA, and what that means in terms of enforcement focus. Our speaker reviews the compliance mistakes made most often by device manufacturers, and provides pointers on how best to interact with FDA.
Tuesday, May 31, 2011
When a 510(k) or PMA Goes Off Track - FDA's Appeals Process
is being presented by Jeffrey K. Shapiro, JD, Director, with Hyman, Phelps & McNamara, PC and airs on Tuesday, June 21st, 2011. For more details, or to register please visit our site at www.fxconferences.com
It goes without saying that the ability to successfully obtain FDA approval is critical to the success of a medical device and, by extension, a medical device company. However, sometimes even the most dedicated of efforts fall flat when FDA says "No." What then? What can you do if FDA says it believes there is not an adequate predicate device for your product? Or if FDA is requiring an overly burdensome clinical study? Or imposing data requirements that were not applied to your competitor's similar 510(k) six months earlier?
This presentation covers the appeals processes that are available to medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA. Our speaker draws upon years of experience to provide practical tips and advice on how to resolve a dispute with FDA so that your 510(k) or PMA can move forward to clearance or approval. The presentation looks at the best approach to take, and what to expect in terms of the length of the appeals process, and the likelihood of success.
It goes without saying that the ability to successfully obtain FDA approval is critical to the success of a medical device and, by extension, a medical device company. However, sometimes even the most dedicated of efforts fall flat when FDA says "No." What then? What can you do if FDA says it believes there is not an adequate predicate device for your product? Or if FDA is requiring an overly burdensome clinical study? Or imposing data requirements that were not applied to your competitor's similar 510(k) six months earlier?
This presentation covers the appeals processes that are available to medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA. Our speaker draws upon years of experience to provide practical tips and advice on how to resolve a dispute with FDA so that your 510(k) or PMA can move forward to clearance or approval. The presentation looks at the best approach to take, and what to expect in terms of the length of the appeals process, and the likelihood of success.
Tuesday, May 10, 2011
FDA on the Edge: What's Next for 510(k)?
is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, June 2nd, 2011. For more details, or to register please visit our site at www.fxconferences.com
Various tracks are coming together in 2011 which will affect the manner in which 510(k)s and other submissions will be reviewed by FDA. The Institute of Medicine report has been peer-reviewed and is expected to be released shortly. However, the FDA list of intended changes contains several items that are about to change, regardless of IOM recommendation.
For medical device manufacturers, it is a time of expectation and, perhaps, a little trepidation. This audio conference takes a look at what is likely to change, and discusses how best to prepare for this new reality.
Various tracks are coming together in 2011 which will affect the manner in which 510(k)s and other submissions will be reviewed by FDA. The Institute of Medicine report has been peer-reviewed and is expected to be released shortly. However, the FDA list of intended changes contains several items that are about to change, regardless of IOM recommendation.
For medical device manufacturers, it is a time of expectation and, perhaps, a little trepidation. This audio conference takes a look at what is likely to change, and discusses how best to prepare for this new reality.
Tuesday, March 29, 2011
FDA's 510(k) De Novo Process - Overview and Current Challenges
is being presented by Dr. Zvi Ladin, Principal, with Boston MedTech Advisors and airs on Thursday, April 28th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Following the enactment of the FDA Modernization Act of 1997, FDA established a new regulatory route for medical devices that present a lower level of risk than Class III and do not have a predicate. ‘De Novo’ applications involve two phases – an initial standard 510(k) process, followed by a review of the risk level of the technology – the De Novo review. The agency committed to completing the second phase within 60 days.
However, things haven't exactly gone according to plan. Until 2007 the average duration of the De Novo review phase was 62 days, with an overall review duration of 245 days. Since 2007 those timelines have stretched to 240 and 482 days respectively – significantly longer than the review of most panel-track, PMA devices.
This audio conference presentation looks at the past, present and future of the De Novo program, how it works, why it hasn't worked as well as expected, and FDA's commitment to review, restructure and streamline the program.
Following the enactment of the FDA Modernization Act of 1997, FDA established a new regulatory route for medical devices that present a lower level of risk than Class III and do not have a predicate. ‘De Novo’ applications involve two phases – an initial standard 510(k) process, followed by a review of the risk level of the technology – the De Novo review. The agency committed to completing the second phase within 60 days.
However, things haven't exactly gone according to plan. Until 2007 the average duration of the De Novo review phase was 62 days, with an overall review duration of 245 days. Since 2007 those timelines have stretched to 240 and 482 days respectively – significantly longer than the review of most panel-track, PMA devices.
This audio conference presentation looks at the past, present and future of the De Novo program, how it works, why it hasn't worked as well as expected, and FDA's commitment to review, restructure and streamline the program.
Monday, September 28, 2009
Indications: The Next Battleground in FDA Advertising Enforcement
Recent Supreme Court decisions have provided new protection to commercial speech, challenging the manner in which FDA regulates industry. In response, FDA takes great care to not mention advertising and has shifted its enforcement focus to indications.
The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.
This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.
Indications: The Next Battleground in FDA Advertising Enforcement was presented by Robert J. Klepinski, Fredrikson & Byron and aired on 2007-01-18. For more details, or to register please visit our site at www.fxconferences.com
The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.
This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.
Indications: The Next Battleground in FDA Advertising Enforcement was presented by Robert J. Klepinski, Fredrikson & Byron and aired on 2007-01-18. For more details, or to register please visit our site at www.fxconferences.com
Monday, December 1, 2008
Indications: The Next Battleground in FDA Advertising Enforcement
Recent Supreme Court decisions have provided new protection to commercial speech, challenging the manner in which FDA regulates industry. In response, FDA takes great care to not mention advertising and has shifted its enforcement focus to indications.
The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.
This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.
Indications: The Next Battleground in FDA Advertising Enforcement was presented by Robert J. Klepinski, of Fredrikson & Byron and aired 2007-01-18. For more details or to purchase a download of this event, please visit our site www.fxconferences.com
The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.
This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.
Indications: The Next Battleground in FDA Advertising Enforcement was presented by Robert J. Klepinski, of Fredrikson & Byron and aired 2007-01-18. For more details or to purchase a download of this event, please visit our site www.fxconferences.com
Tuesday, July 1, 2008
Understanding the Principles and Pitfalls of 510k Submissions
Obtaining premarket clearance for medical devices can be a challenging task. However, it is somewhat less daunting when you start out with a solid understanding of what is expected by the FDA and how the review process works.
This audio conference provides an understanding of the technical requirements of 510k submissions, provide practical advice on preparation of the documents and give an overview of the options and strategies associated with obtaining premarket clearance for medical devices. The speaker also draws on her extensive experience to provide valuable insights for minimizing the pitfalls and common mistakes associated with these types of FDA submissions.
This audio conference is presented by Rebecca Pine of Eisner Safety Consultants. To learn more, visit www.fxconferences.com.
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