CDRH Seeks Comments on 510(k) Device Process

GenomeWeb Daily News

CDRH Seeks Comments on 510(k) Device Process

February 11, 2011

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – The US Food and Drug Administration's Center for Devices and Radiological Health is reaching out to industry and the public for input on its plans to change the process for handling 510(k) submissions by collecting public meeting in March.

As GenomeWeb Daily News reported in January, CDRH has issued a 25-point plan aimed at streamlining the review process, clarifying when clinical data should be submitted, and establishing a council of FDA experts to assist applicants in making decisions.

CDRH Director Jeffrey Shuren said at the time that the changes will result in "a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly."

These steps are being considered in order to "strengthen" the review process and to "improve the predictability, consistency, and transparency of its decision-making," CDRH said in a Federal Register posting this week.

"These actions will not only improve the safety of medical devices but also increase the ability of innovating companies to attract investors, estimate costs, and more quickly bring products to market," according to CDRH.

The Center plans to hold is public meeting on March 15 in Silver Spring, Md., at FDA's White Oak Campus.

CDRH is seeking comments on its report in general, as well as in certain areas, such as the eligibility criteria for the new programs; how CDRH should determine what types of technologies will be included in some of these new innovation initiatives; how time frames for the program should work; what criteria should be used for clinical test center certification; how candidates for inter-agency or public-private partnerships will be defined; and other actions CDRH should take to facilitate the development, assessment, and regulatory review of innovative medical devices.

Public Docket for comments on Array-Based Cytogenetic Tests

Thought it wold be interesting to see the public comments submitted tot he docket for this item.  See previous posts where FDA (CDRH) had projected issuing a framework for the validation and review of array CGH assays.

Here is a link to the docket at regulations.gov.

http://www.regulations.gov/#!searchResults;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2010-N-0259


There have really only been 2 comments posted from the public.

The College of American Pathologists (http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0259-0003.1) and
The Cleveland Clinic (http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0259-0002.1)

The only other items posted are the original Federal Register notice announcing the June 30, 2010 public meeting (http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0259-0001) and the actual transcript of the public meeting (http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0259-0004).

Interestingly, FDA does not even seem to have posted the various presentations given at the public meeting to the docket.

Public Docket for FDA/CDRH Medical Device Innovation Initiative

If you are interested in following the comments posted to the Public Docket (FDA-2011-N-0062) for this FDA activity, here is a direct link.
http://www.regulations.gov/#!searchResults;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2011-N-0062


http://www.regulations.gov/#!home

FDA/CDRH's External Expertise Partnerships (EEP) Program

External Expertise and Partnerships (EEP)

The Center for Devices and Radiological Health (CDRH) regulates a wide array of medical devices. To keep pace with the rapid development of new technology, and to make decisions based on the best scientific information and knowledge available, CDRH routinely collaborates with experts in the academic community, government entities, clinical practice, and industry. External Expertise and Partnerships is located in the Office of the Center Director in CDRH.

• EEP's Mission
• Three Components of EEP
• The Medical Device Fellowship Program (MDFP)
• Partnerships and Technology Transfer
• The Critical Path Initiative

EEP's Mission

EEP's mission is to advance public health by acquiring specialized expertise and material resources that support scientific and clinical evaluations conducted in the offices of CDRH. By filling gaps in expertise for a finite period of time, EEP enhances the efficiency and effectiveness of CDRH operations. EEP is the focal point of all CDRH fellowships and interorganizational partnerships. EEP also fosters scientific innovation by helping offices form partnerships with academia, private sector organizations, and government agencies. The consulting and oversight services facilitate project success and ensure that CDRH employees operate within the context of all legal obligations.

Three Components of EEP

EEP is divided into three general components:

1. The Medical Device Fellowship Program (MDFP)
2. Partnerships and Technology Transfer
3. The Critical Path Initiative

The Medical Device Fellowship Program (MDFP)

The Medical Device Fellowship Program began at CDRH in 2003 with the goal of advancing public health by acquiring specialized expertise and material resources for a finite period of time in support of scientific and clinical evaluations conducted in the offices of CDRH. The Fellowship Program addresses how to place external expertise for targeted projects.

Fellows are full-time or part-time Food and Drug Administration (FDA) employees. Qualified individuals, including clinicians, scientists, researchers, academics, and students in appropriate fields, enjoy unique experiences working with world-class scientists, physicians, and engineers, while helping bring innovative technologies to market. There are opportunities to present research results through publications and presentations.

EEP coordinates MDFP fellows and projects, as well as the CDRH fellowship projects for the FDA Commissioner’s Fellowship Program (CFP) and the FDA-NCI Interagency Oncology Task Force (IOTF) Fellowship.

Related Links

• Medical Device Fellowship Program
• Commissioner's Fellowship Program
•  FDA-NCI Interagency Oncology Task Force (IOTF)

Partnerships and Technology Transfer

Partnership and Technology Transfer refers to the processes involved in facilitating the transfer of expertise, technology, materials, equipment, and intellectual property. The activities in this area include: advising and consulting with appropriate staff and principal investigators (PIs), determining partnership mechanisms, guiding collaborations, developing and executing partnership tools, fostering communication, and providing oversight through the many phases of collaborations. EEP is the contact point for CDRH Technology Transfer and partnership activities.

Technology transfer has been defined by the Federal Laboratory Consortium for Technology Transfer as follows:

“Technology transfer is the process by which existing knowledge, facilities, or capabilities, developed under federal research and development (R&D) funding, are used to fulfill public and private needs.”

This list is a general overview of technology transfer mechanisms that serve as partnership tools:

Confidential Disclosure Agreements (CDAs)

• Provide protection against disclosure of proprietary information

Material Transfer Agreements (MTAs)

• Are simple agreements between government, academic, or private sector partners (industry or professional societies)
• Permit the transfer of disposable equipment, supplies, materials, or proprietary data or information that is trade secret
• Involve no interactive collaboration

Cooperative Research and Development Agreements (CRADAs)

• Provide mutually beneficial collaboration and cooperation between FDA and government, academic, or private sector partners (industry or professional societies)
• Enable collaborator to contribute personnel, equipment, materials, or funds
• Enable government to contribute personnel, equipment, or materials, but NOT funds

Grants

• Are funding provided from the government or private sector for a specific project by an application process

Interagency Agreements (IAAs), or IAGs

• Are formal agreements between FDA and other Federal agencies
• Concern transfer of funds, provision of services, loan of staff, or use of property, facilities, or equipment, or exchange of information (costly)

Memorandums of Understanding (MOUs), also known as Memorandums of Agreement (MOAs)

• Represent agreement between two or more government, academic, or private sector partners (including nonprofits, professional societies, etc.)
• Establish organizational links in Technology Transfer
• Are announced by publication in the Federal Register

Related Links

• CDRH Cooperative Research and Development Agreements (CRADAs)
• FDA CRADAs

The Critical Path Initiative

The Critical Path Initiative facilitates a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or “proof of concept” into a medical product. The initiative was launched in 2004 after the release of a report titled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. The report highlighted the difficulty and unpredictability of medical product development and called for a concerted effort to modernize the scientific tools (e.g., in vitro tests, computer models, qualified biomarkers, innovative study designs) and harness the potential of bioinformation used to evaluate and predict safety, effectiveness, and manufacturability of candidate medical products.


The Critical Path Initiative holds potential to improve the tools FDA uses to evaluate the safety and efficacy of human and veterinarian products and the safety and nutrition of food and food ingredients. In another area, new bioinformatics approaches could greatly enhance the interoperability of information tracking systems in the healthcare environment for all regulated products (e.g., adverse events reporting). As resources allow, FDA will initiate partnerships to address some of these scientific hurdles. EEP coordinates CDRH's Critical Path projects.

Related Links

• CDRH Critical Path Projects FY2009
• CDRH Critical Path Projects FY2010
• Critical Path Initiative

FDA launches Medical Device Innovation Initiative

FDA NEWS RELEASE

For Immediate Release: Feb. 8, 2011
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA launches Medical Device Innovation Initiative
DARPA-funded prosthetic is first test case

Today the U.S. Food and Drug Administration proposed the Innovation
Pathway, a priority review program for new, breakthrough medical devices
and announced the first submission: a brain-controlled, upper-extremity
prosthetic that will serve as a pilot for the program. The FDA also
announced plans to seek further public comment before the Pathway can
be used more broadly.

The new proposed Innovation Pathway program for pioneering medical
devices, highlighted in a report published on the FDA’s website today,
is part of a broader effort underway in the FDA’s Center for Devices and
Radiological Health (CDRH) designed to encourage cutting-edge
technologies among medical device manufacturers.

The initiative will also seek to strengthen the nation’s research
infrastructure for developing breakthrough technologies and advancing
quality regulatory science. Proposed actions include:

• establishing a voluntary, third-party certification program for U.S.
medical device test centers designed to promote rapid improvements
to new technologies during a product’s development and clinical testing
stages;
• creating a publicly-available core curriculum for medical device
development and testing to train the next generation of innovators; and
• using more device experience and data collected outside the United
States.

In addition, CDRH intends to engage in formal horizon scanning –
monitoring medical literature and scientific funding in a systematic way
to predict where technology is heading. CDRH will include public input
in this process to prepare for and respond to transformative innovative
technologies and scientific breakthroughs.

“Each year, millions of American patients benefit from innovative medical
devices that reduce suffering and treat previously untreatable conditions,”
said CDRH Director Jeffrey Shuren, M.D., J.D. “CDRH’s Innovation Initiative
 will help accelerate the development of and patient access to innovative
medical devices, which often fulfill unmet public health needs.”

The FDA has accepted its first submission from the Defense Advanced
Research Projects Agency (DARPA) to review a brain-controlled,
upper-extremity prosthetic designed to restore near-natural arm, hand
and finger function to patients suffering from spinal cord injury, stroke
or amputation.  The arm system uses a microchip implanted on the
surface of the brain to record neuronal activity and decode the
signals to actuate motor neurons that control the prosthesis. DARPA
and the FDA have signed a Memorandum of Understanding addressing
both the development and review of this project.

The proposed Innovation Pathway program includes the following features:

• products would have to be truly pioneering technologies with the
potential of revolutionizing patient care or health care delivery;
• selected products would receive an Innovation Pathway memorandum
from CDRH containing a proposed roadmap and timeline for device
development, clinical assessment and regulatory review; and
• products would be assigned a case manager, their important scientific
issues would be identified and addressed earlier in the development process,
and they might be able to qualify for flexible clinical trial protocols.

Applications would be reviewed by the Center Science Council, a new
oversight body currently being developed within CDRH comprised of senior
managers and experienced scientists, who would facilitate this device
development and evaluation process. Enrollment in the Innovation Pathway
program would not change the scientific or regulatory standards that
CDRH would use to evaluate device submissions and determine their
appropriateness for marketing. 

Because of the transformative nature of the devices that would be eligible
for this pathway, CDRH expects them to generally be approval pathways
intended for either high risk or novel products.

The FDA could conduct premarket reviews of products in the Innovation
Pathway within 150 days, nearly half the time it currently takes the FDA
to review most premarket approval applications.

CDRH has set up a public docket to solicit public comment on the
Innovation Initiative and will host a public meeting on the topic on
March 15, 2011 at the Center’s White Oak campus.

For more information:

• CDRH Medical Device Innovation Initiative at
  http://www.fda.gov/deviceinnovation

Links from the FDA website

Medical Device Innovation Initiative Documents

• Medical Device Innovation Initiative White Paper  
• Questions and Answers about the Medical Device Innovation Initiative  
• Innovation Initiative Remarks - Jeffrey Shuren, M.D., J.D., Director FDA's Center for Devices and Radiological Health  
• Federal Register: Medical Device Innovation Initiative; Request for Comments  

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-

Opportunities to Comment on the Medical Device Innovation Initiative

• Public Workshop - Center for Devices and Radiological Health's Innovation Initiative, March 15, 2011  

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Related Links:

• Public Workshop: Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development, June 24, 2010  

-

-

Webcast:

• Medical Device Innovation Initiative Webcast (Audio) (MP3 - 24787KB)  
• Medical Device Innovation Initiative Webcast (Transcript) (PDF - 48KB)  

Post from Genomics Law Report on DTC Genetic tests

Genomics Law Report ^®

News and analysis from the intersection of genomics, personalized medicine and the law

Update: FDA Taking Another (Public) Look at DTC Genetic Tests

Posted by Dan Vorhaus on February 8, 2011

Direct-to-consumer (DTC) genetic tests are back on the FDA’s public radar screen. A month from today, the agency’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet to “discuss and make recommendations on scientific issues concerning [DTC] genetic tests that make medical claims.” Here is the Federal Register notice (pdf).
The two-day meeting, which is open to the public, will investigate the following topics:

• The risks and benefits of making clinical genetic tests available for “direct access by a consumer without the involvement of a clinician (i.e., without a prescription).”
• The different types of DTC or direct access tests (e.g., carrier screening, risk prediction in healthy persons, pharmacogenetics, etc.) that might “support differences in the regulatory approach.”
• The “level and type of scientific evidence appropriate for supporting [DTC] claims, including whether it should be different than” what is required for similar clinical genetic tests (presumably, non-DTC in vitro tests, including laboratory developed tests, or LDTs).

A complete agenda and list of speakers has yet to be published, but the fact that the FDA is singling out DTC genetic tests for specific attention is sure to be a welcome sign to many.  In the whirlwind of activity this past summer, DTC genetic test providers were haled before both Congress and the FDA to defend their businesses, even as the FDA simultaneously unveiled plans to regulate all LDT tests. The frenetic pace of activity left industry, the public and, seemingly, the FDA with a number of unanswered questions. Chief among them: does the FDA consider DTC genetic tests to be LDTs, or do the unique issues raised by direct consumer access to these relatively new products merit separate regulatory consideration? This confusion was reflected in the FDA’s two-day public meeting on LDT regulation and in the written public comments submitted over the following months, which saw a disproportionately high number focus primarily or exclusively on DTC genetic tests, despite the fact that those tests comprise only a fraction of the tens of thousands of LDTs the FDA is seeking to regulate.  Which is what makes next month’s DTC-only meeting such a good idea. The meeting is a tacit acknowledgement by the FDA that the agency needs to continue to gather data and viewpoints about DTC genetic tests, along with the unique opportunities and challenges they present, separately from its ongoing efforts at LDT regulation. As a recent Nature Biotechnology editorial suggests, it may also mark the start of a shift in the FDA’s attitude toward the regulation of DTC genetic tests, prompted in part by recent direction from President Obama and the White House, to take a closer look at how agency regulations burden small businesses and to demonstrate an “increased flexibility” in reducing those burdens. That’s significant, especially when coupled with the results of a recent study published in the New England Journal of Medicine by researchers from the Scripps Translational Science Institute (pdf). The Scripps study evaluated the responses of over 2,000 DTC genetic test customers (who used Navigenics’ Health Compass product) and found no significant post-test anxiety or other adverse results. While it will take time to assess the full impact of both the Scripps study (which will require, among other things, longitudinal follow-up and independent confirmation) and the Obama Administration’s new regulatory policies, Nature Biotechnology opines that these signs suggest that the FDA’s “stance to the DTC genetics sector has been perhaps too aggressive” thus far. We agree.

Whatever the FDA’s attitude toward DTC genetic tests in the past, the upcoming public meeting is a positive development. By continuing to facilitate public dialogue—the public may submit comments to the agency in writing until February 23 and apply (until February 15) to make an oral presentation at the meeting—the FDA is sending a clear signal that it recognizes it cannot develop an appropriately tailored system of oversight for DTC genetic tests without consulting, directly and repeatedly, the public it seeks to inform and to protect.

One final note on timing. In early January, despite the ongoing legal and regulatory uncertainty and before the Obama Administration unveiled its new business-friendly approach to regulation, we wrote that direct federal regulation of the DTC genetic testing industry in 2011 appeared highly unlikely. As we head into the spring, with the FDA still clearly in information-gathering mode and Washington’s short-term focus on other priorities, including lessening regulatory burdens overall, there is no reason to adjust that prediction. This should come as welcome news for those who have argued that what the DTC genetic industry needs today is greater transparency and better data, not heightened regulation.

Friday, February 4, 2011 Federal Register - FDA items

Food and Drug Administration
RULES
New Animal Drugs:
	Masitinib ,
	6326–6327 [2011–2519]		[TEXT]  [PDF]
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
	Animal Drug User Fees and Fee Waivers and Reductions ,
	6475–6476 [2011–2441]		[TEXT]  [PDF]
Meetings:
	Industry Exchange Workshop on Drug and Device Requirements ,
	6477–6478 [2011–2458]		[TEXT]  [PDF]
	Town Hall Discussion with Director of Center for Devices and Radiological Health and Other Senior Center Management ,
	6476–6477 [2011–2490]		[TEXT]  [PDF]