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  

-

-

Opportunities to Comment on the Medical Device Innovation Initiative

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

-

-

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]

Thursday, February 3, 2011 Federal Register - FDA items

Food and Drug Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
	Current Good Manufacturing Practice Regulations for Type A Medicated Articles ,
	6142–6143 [2011–2355]		[TEXT]  [PDF]
Draft Guidance for Industry; Availability, etc.:
	Target Animal Safety and Effectiveness Protocol Development and Submission ,
	6143 [2011–2315]		[TEXT]  [PDF]
Draft Guidance; Availability, etc.:
	Positron Emission Tomography Drug Applications – Content and Format for New Drug Applications, etc. ,
	6143–6144 [2011–2314]		[TEXT]  [PDF]
Meetings:
	Positron Emission Tomography ,
	6144–6146 [2011–2313]		[TEXT]  [PDF]

FDA Deadlines and Transparency - NOT

A few days ago (January 31, 2011) the first targeted deliverable date from the FDA's 2011 Strategic Priorities for CRDH came an went with no deliverable.  We anticipated seeing FDA's framework for the validation and review of array CGH assays.

I am reminded of another "deliverable" that remains missing.  On July 16, 2009, FDA cleared a 510(k) premarket notification (actually a de novo submission) for Vermillion's OVA1 Test (Intended use: The OVA1™ Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay.  Although clearance was granted in July, the detaill were not posted to the FDA website until about a month later (that seems about normal) and the FDA press release about the clearance was issued September 11, 2009 (nearly 3 months later - is that normal?).

Like many of you, I have been under the impression (apparently mistakenly) that part of the process for clearing a de novo 510(k) was the development of a Special Controls guidance document. The Special Controls guidance document was identified in the FDA clearance letter for the Vermillion assay (http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081754.pdf).  To date, FDA still has not issued the guidance.  When contacted several months ago, the story was that it was "difficult" to issue guidance.  I must concur.  It seems extremely difficult since now 18 months have passed since the 510(k) was cleared and FDA has not been able to issue a guidance document that should have been completed at the time the 510(k) was cleared.

Today it is Groundhog Day and I suspect we will see a good deal of time, say six more weeks of waiting (apologies to the groundhog) until we see the promised framework.  I'm not holding my breath for the MIA guidance document.
 

 

Where is the Framework for Validation and Review of Array CGH Applications?

In its "2011 Strategic Priorities" document for CDRH, FDA projected that by yesterday (January 31, 2011), it would finalize a framework for the validation and review of array CGH applications.  Yesterday came and went without any news about the status of the framework.  If I was an array manufacturer (or user) I'd be most curious to know what was happening.  (Interesting that it was to be finalized before even issued as a draft).

Is it an oops - "We didn't realize it was due" or maybe "the dog ate it" or maybe

"We bit off more than we could chew - it's "coming soon".

So far FDA is 1 due date passed and 0 goals met.  24 more to go.

FDA CBER Office of Cellular, Tissue and Gene Therapies (OCTGT) Online Courses

Here is where the utility of the internet begins to shine and FDA is taking advantage of what it has to offer.

The following multimedia courses are currently offered online from CBER's Office of Cellual, Tissue and Gene Therapies (OCTGT). You may submit suggestions for future courses to OCTGTLearn@fda.hhs.gov. 
    

Course List

• Introduction and Scope of OCTGT  
  Presenter: Patrick Riggins. Patrick Riggins introduces the Office of Cellular, Tissue and Gene Therapies and provides a scope of what the office does.
• IND Basics in OCTGT  
  Presenter: Patrick Riggins. This presentation looks at the basics of IND submission in OCTGT.
• Sponsor Meetings with OCTGT  
  Presenter: Lori Tull. Lori Tull describes various sponsor meetings with OCTGT.
• “361” Human Cells, Tissues, & Cellular and Tissue Based Products  
  Presenter: Samuel Barone. In this presentation, Samuel Barone describes what HCT/Ps are and how they are regulated.
• The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND  
  Presenter: Andrew Byrnes. In this presentation, Andrew Byrnes explains the basics of how to put together the CMC section of a gene therapy IND, particularly for Phase 1 trials.
• Advanced Topics: Successful Development of Quality Cell and Gene Therapy Products  
  Presenter: Denise Gavin. Denise Gavin aims to guide manufacturers toward successful development of quality cell and gene therapy products, in this presentation.
• Cellular Therapy Products  
  Presenter: Keith Wonnacott. Keith Wonnacott discusses information that is needed to prepare an investigational new drug application for a cellular therapy product.
• Preclinical Considerations for Products Regulated in OCTGT  
  Presenter: Allen Wensky. Allen Wensky provides a basic overview of preclinical considerations that make up one of the three key elements of an IND submission.