FDA on Medical Devices: Part 1 – User Fee Act (MDUFA) III and Part 2 – Expedited Access Program for Medical Devices that Address Unmet Medical Needs
Reporter: Aviva Lev-Ari, PhD, RN
Part 1 – User Fee Act (MDUFA) III
Medical Device User Fee Act (MDUFA) III
Product Id : MD1056 Category : Medical Devices
Scheduled On : Tuesday, June 10, 2014 at 13:00 Hrs US/Canada (Eastern Time – EDT)US/Canada (Central Time – CDT)US/Canada (Mountain Time – MDT)US/Canada (Pacific Time – PDT)USA – Alaska Time – AKDTCanada (Atlantic Time – ADT)Australia (Eastern-AEST)Australia (Western-AWST)Brazil (BRT)China/Hong KongCosta RicaCentral EuropeGuatemalaIndiaKorea/JapanMalaysia/SingaporeMexicoNew ZealandNigeriaPeuorto RicoUAEUnited Kingdom (GMT)
Duration : 90 Minutes Description :
This webinar will present the results of the MDUFA III and will describe how your company will need to do business with the FDA in the next five years. It will describe how the FDA will use the User Fees to make changes within the agency and the expectations that the FDA will have of your company, as a result of those changes, to help your company prepare both strategically and tactically for regulatory interactions in the next five years. The new guidance that have resulted from “Refusal-to-Accept” and Electronic Submissions of Medical Device applications will also be presented.
Device user fees were first established by Congress in 2002. Medical device companies pay fees to FDA when they register their establishment and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. As part of receiving such fees, the FDA makes commitments to the industry with regards to certain performance goals with regards to review and approval processes and timelines.
The Medical Device User Fee Amendments of 2012, or MDUFA III took effect on October 1, 2012 and will sunset in five years on October 1, 2017. During that time, the processes for interacting with the FDA will be updated, impacting the way a medical device manufacturer does business with the FDA.
Change is inevitable; Suffering is optional!!! This is the best way to describe the Medical Device User Fee Act III that, among other things, changes the way that the FDA accepts submissions for Medical Devices. This will cause significant changes in how Medical Device Companies need to handle 510(k) and PMA submissions between the years 2012-2017.
This webinar will include review of the changes the FDA is making in accepting Medical Device Submissions and will propose solutions to some of the problems that will result from those changes. The goal of the webinar is to reduce / eliminate suffering from these changes, by discussing the strategies required to move forward with minimal disruption to the business.
Areas Covered in the Session :
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
For Live – How it works:
For Recording – What you will receive:
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Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Life science industry
SOURCE
Part 2 – Expedited Access Program for Medical Devices that Address Unmet Medical Needs
FDA NEWS RELEASE
For Immediate Release: April 22, 2014
Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA proposes new expedited access program for medical devices that address unmet medical needs
Agency also clarifies policy on when manufacturers can collect data after approval
Today, the U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.
The proposed Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (“Expedited Access PMA” or “EAP”) program features earlier and more interactive engagement with FDA staff—including the involvement of senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval—features that, taken together, should provide these patients with earlier access to safe and effective medical devices.
EAP is not a new pathway to market, but rather a collaborative approach to facilitate product development under the agency’s existing regulatory authorities. While other existing device programs have focused on reducing the time for the premarket review, EAP also seeks to reduce the time associated with product development.
“We are excited to offer a proposed program for expedited access for certain high-risk medical devices,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The program allows manufacturers to engage early and often with the agency. We expect most devices that enter this program will be in the pre-clinical trial phase.”
To be eligible for participation in the program, the medical device must:
• Be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition
• Represent one of the following:
1. no approved alternative treatment/diagnostic exists, or
2. a breakthrough technology that provides a clinically meaningful advantage over existing technology, or
3. offers a significant, clinically meaningful advantage over existing approved alternatives, or
4. availability is in the patient’s best interest
• Have an acceptable data development plan that has been approved by the FDA
The EAP builds on the Innovation Pathway pilot, which the FDA launched in 2011, and the FDA’s experience with expedited review programs for pharmaceuticals, including Accelerated Approval and Breakthrough Therapies. When utilizing the EAP program, the FDA will continue to apply the current approval standard of demonstrating a reasonable assurance of safety and efficacy.
In addition to the Expedited Access Program, the FDA published a separate draft guidance that outlines the agency’s current policy on when data can be collected after product approval and what actions are available to the FDA if approval conditions, such as postmarket data collection, are not met. Included in the guidance is advice on the use of surrogate or independent markers to support approval, similar to the data points used for accelerated approval of prescription drugs.
“To assure that a device is safe and effective and provide timely patient access to breakthrough devices, it’s critical to get the right balance between pre-market data collection and post-market data collection,” said Dr. Shuren.
The FDA seeks public comment on both documents.
• Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance for Industry and FDA Staff
• Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval – Draft Guidance for Industry and FDA Staff
For more information:
FDA: Medical Devices
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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