Navigation Links
AMP asks FDA to address barriers to device innovation
Date:6/25/2010

Washington, DC (June 25, 2010): Yesterday, the Association for Molecular Pathology (AMP) gave public comments at the FDA's Center for Devices and Radiological Health (CDRH) Council meeting on Medical Device Innovation: Barriers to Market for Molecular Diagnostic Tests.

AMP commends the Federal departments and agencies that compose the Council on Medical Device Innovation for making efforts to identify and remove barriers to innovation and progress in transitioning basic and transitional research findings into routine clinical practice. In its remarks, AMP identified three barriers that impede the path to FDA clearance or approval for diagnostic tests and reduce the motivation to submit some medically useful tests for review.

Barrier 1. The paucity of standard reference materials for all areas of molecular diagnostics, i.e., genetic, oncology, and infectious disease testing, inhibits the production of appropriate control materials and methods. "AMP is eager to see more progress and investments in this area," said Dr. Mark Sobel, AMP's Executive Officer. "FDA can assist by providing a list of needed standard reference materials to relevant organizations such as the National Institute of Standards and Technology (NIST) and World Health Organization (WHO)."

Barrier 2. The difficulty of obtaining rare specimens for studies presents a barrier to submission of applications for the approval of new indications for currently approved tests. Herpes Simplex Virus (HSV) testing has been the standard of care for the diagnosis of central nervous system (CNS) disease (HSV encephalitis and meningitis) for over a decade, yet an FDA approved test does not yet exist. HSV CNS infections are relatively rare and any individual laboratory may receive only 1-2 HSV encephalitis positive specimens a year. Manufacturers who developed assays for the novel 2009 influenza H1N1 strain encountered similar difficulties in validating their assays using prospective clinical specimens after the peak of the pandemic had passed.

Dr. Sobel identified a potential solution to the shortage of specimens, "The FDA should work to establish a biorepository of clinically relevant infectious agents, including strain variants and subtypes, to facilitate the rapid development and validation of assays for infectious agents, particularly those with pandemic potential." Alternatively, AMP also asked the FDA to consider establishing alternative validation strategies that are independent of primary clinical specimens, but are, nonetheless, rigorously grounded in sound science and infectious disease medicine.

Barrier 3. Test manufacturers perceive that there is an inconsistent and unclear regulatory pathway for their submissions. Manufacturers have faced uncertainty and/or inconsistency in the review of device submissions, in enforcement discretion, in device classification [510(k), 510(k) de novo, PMA, ASR, etc.], in requirements for acceptable analytical and clinical validations, and in requirements changing from the time of pre-IDE meetings through mid-trial. "IVD test manufacturers must then function within this uncertain regulatory environment, which makes it difficult to anticipate regulatory requirements and appropriately amend their business models," said Dr. Sobel.

To address the barriers identified above, AMP believes that the FDA can take several steps that would improve the regulatory process for molecular diagnostic tests without impinging upon an appropriate review to ensure that the public is protected.

  • FDA should ensure that policies and requirements are consistently applied, and that the scientific evidence and rationale for decisions are communicated effectively to diagnostic test manufacturers.
  • Communication from FDA to diagnostic test manufacturers should be as clear and as comprehensive as possible at the outset of the submission process. This will help manufacturers better plan their resources and time. It will also assuage undue angst that the regulatory bar will change during the process.
  • FDA should improve communication between government branches and agencies so that consistent requirements are developed and applied and demonstrations of clinical utility in one branch are recognized by the other branches.
  • FDA should involve the expert opinion of medical professional associations regarding clinical utility.

The Association for Molecular Pathology recognizes the difficulties that regulatory agencies face in the context of the rapidly changing landscape of diagnostic devices and technology and appreciates the transparent process FDA is undertaking to improve the review process for medical devices. AMP believes that a consistent, clear, and flexible regulatory process will result in improved public access to additional higher quality innovative tests; and could conceivably lower healthcare costs.

"AMP stands ready to assist the FDA through our expertise, creative problem solving, and unique perspective," added Dr. Sobel. "We would like to offer our input and interaction with the member departments and agencies to assist in developing a more consistent, evidence-based, and transparent process for regulating diagnostic devices."


'/>"/>

Contact: Mary Steele Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

Related medicine news :

1. National Oncologist Group Warns: Current Health Care Reform Legislation Woefully Short In Addressing Cancer Care Crisis
2. National Oncologist Group Warns: Current Health Care Reform Legislation Woefully Short in Addressing Cancer Care Crisis
3. Statement From American Heart Association CEO Nancy Brown on President Obamas State of the Union Address
4. Statement From the American Health Care Association and National Center for Assisted Living in Anticipation of President Obamas State of the Union Address
5. Props for the President at His State of the Union Address
6. Greenfaith Ministry Calls on Churches & Doctors, to Address all Cannabis Issues and Regulation
7. HealthWyse Clinical and Financial Point of Care Software Addresses OASIS-C Regulations and More
8. New England Journal of Medicine Perspective by Irwin Redlener, MD, Addresses Health Care Reform
9. Aging Expert's New Book Helps Boomers Address Challenges of Caregiving
10. Abortion Compromise Does Not Address Core Problem In Senate Health Bill, Says Cardinal DiNardo, Bishops Pro-Life Chair
11. Study Finds Family Members Play Critical Role in Addressing Loved Ones' Hearing Loss
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... , ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter ... bar too high can result in disappointment, perhaps even self-loathing. However, those who set ... , Research from PsychTests.com reveals that behind the tendency to set low ...
(Date:6/24/2016)... ... , ... Marcy was in a crisis. Her son James, eight, was out of control. Prone ... physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If ... at my other children and say he was going to kill them. If we ...
(Date:6/24/2016)... ... , ... Comfort Keepers® of San Diego, CA is excited to announce they ... to drive cancer patients to and from their cancer treatments. Comfort Keepers provides ... life and ongoing independence. Getting to and from medical treatments is one of ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute ... Dr. Barry M. Weintraub as a prominent plastic surgeon and the network’s newest ... world, and the most handsome men, look naturally attractive. Plastic surgery should be ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, ... dedicated to helping service members that have been wounded in battle and their families. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
(Date:6/23/2016)... , June 23, 2016 Research and ... Global Market - Forecast to 2022" report to their ... treatment method for the patients with kidney failure, it replaces ... fluid from the patient,s blood and thus the treatment helps ... and chloride in balance. Increasing number of ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... Forecast to 2022" report to their offering. ... date financial data derived from varied research sources to present ... impact on the market during the next five years, including ... sub markets, regional and country level analysis. The report provides ...
Breaking Medicine Technology: