Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

FDA Proposes New Expedited Access Program for Medical Devices

Published: Tuesday, April 22, 2014
Last Updated: Tuesday, April 22, 2014
Bookmark and Share
New program would provide earlier access to high-risk medical devices that address unmet needs in the treatment or diagnosis of patients with serious conditions.

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.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,700+ scientific posters on ePosters
  • More Than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Advancing Precision Medicine by Enabling a Collaborative Informatics Community
The FDA is developing an informatics platform that will facilitate the sharing of expertise of knowledge in the field of precision medicine.
Wednesday, August 12, 2015
FDA Declares Trans Fatty Acids Unsafe for Consumption
TFAs are widely recognized as the most harmful fat with regard to causing cardiovascular disease (CVD).
Wednesday, July 15, 2015
FDA Seeks $4.9 billion to Implement the FDA Food Safety Modernization Act
FY 2016 request reflects a nine percent increase from FY 2015 budget, aims to improve the quality and safety of the medical products Americans use.
Monday, February 23, 2015
FDA Issues Additional Guidance For Outsourcing Facilities That Compound Sterile Human Drugs
Agency outlines details on registration, fees, and drug product reporting for outsourcing facilities.
Tuesday, November 25, 2014
FDA Rules Will See Calorie Counts on Menus
The menu labeling final rule applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations.
Tuesday, November 25, 2014
FDA Food Safety Challenge
Challenge aims to spur new technologies for fighting foodborne illness.
Friday, September 26, 2014
FDA Allows Marketing of T2Candida
FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample.
Tuesday, September 23, 2014
FDA Issues Guidance on Use of Nanotechnology in Food Production
The three final guidances and one draft guidance provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
Tuesday, July 01, 2014
FDA, EMA Strengthen Pharmacovigilance Collaboration
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance topics.
Thursday, February 20, 2014
FDA Approves First Generic Versions of Antidepressant Drug Cymbalta
The U.S.FDA approved the first generic versions of Cymbalta), a prescription medicine used to treat depression and other conditions.
Monday, December 16, 2013
FDA Approves First Adjuvanted Vaccine for Prevention of H5N1 Avian Influenza
Vaccine to supplement National Stockpile, not intended for commercial availability.
Wednesday, November 27, 2013
FDA Takes Step to Help Ensure the Safety of Imported Food
Agency releases new proposed rules under FSMA for verifying foreign suppliers and accrediting third-party auditors.
Monday, July 29, 2013
FDA Approves Simponi to Treat Ulcerative Colitis
The U.S. FDA approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Monday, May 20, 2013
FDA Accepts Biogen Idec’s Biologics License Application
ELOCTATE™ has potential to provide long-lasting protection and markedly reduce treatment burden for patients.
Tuesday, May 14, 2013
FDA Proposes New Food Safety Standards for Foodborne Illness Prevention and Produce Safety
Public encouraged to comment on new proposals.
Monday, January 07, 2013
Scientific News
Breaking Through the Barriers to Lab Innovation
Here we examine the drivers behind the move for greater innovation, the challenges and current trends in laboratory informatics, and the tools that can be used to break these barriers.
Education and Expense: The Barriers to Mass Spectrometry in Clinical Laboratories?
Here we examine the perceived barriers to mass spec in clinical laboratories and explore the possible drivers behind the recent shift in uptake of the technology in clinical settings.
Removing 62 Barriers to Pig–to–Human Organ Transplant in One Fell Swoop
The largest number of simultaneous gene edits ever accomplished in the genome could help bridge the gap between organ transplant scarcity and the countless patients who need them.
Fruit Fly Pheromone Flags Great Real Estate for Starting a Family
Finding could aid efforts to control mosquito-borne diseases like malaria by manipulating odorants
Gene Editing Could Enable Pig-To-Human Organ Transplant
The largest number of simultaneous gene edits ever accomplished in the genome could help bridge the gap between organ transplant scarcity and the countless patients who need them.
Antioxidants Cause Malignant Melanoma to Metastasize Faster
Fresh research at Sahlgrenska Academy has found that antioxidants can double the rate of melanoma metastasis in mice.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Adult High Blood Pressure Risk Identifiable in Childhood
Groups of people at risk of having high blood pressure and other related health issues by age 38 can be identified in childhood, new University of Otago research suggests.
Analyzing Protein Structures in Their Native Environment
Enhanced-sensitivity NMR could reveal new clues to how proteins fold.
Supercoiled DNA is Far More Dynamic Than the “Watson-Crick” Double Helix
Researchers have imaged in unprecedented detail the three-dimensional structure of supercoiled DNA, revealing that its shape is much more dynamic than the well-known double helix.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,700+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos