2011-2916. Medical Device Innovation Initiative; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a document for public comment entitled “Medical Device Innovation Initiative” (the report). The report proposes potential actions for FDA's Center for Devices and Radiological Health (CDRH) to facilitate the development, assessment, and regulatory review of innovative medical devices.

DATES:

Submit either electronic or written comments on the report by April 11, 2011.

ADDRESSES:

See the SUPPLEMENTARY INFORMATION section for electronic access to the report.

Submit electronic comments on the report to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Jonathan Sackner-Bernstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5410, Silver Spring, MD 20993, 301-796-5420, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

The United States is the global leader in medical device innovation and CDRH is committed to assuring that American patients have timely access to important new technologies and next-generation products without compromising their safety. Each year, millions of American patients benefit from innovative medical devices that reduce suffering, treat previously untreatable conditions, extend lives, and improve public health.

CDRH is responsible for advancing public health and facilitating innovation to help bring novel technologies to market and make the medical devices that are already on the market safer and more effective. Recently, CDRH announced 25 actions it will take in 2011 to strengthen its most widely-used premarket review process—the 510(k) program—and increase its use of emerging science to foster innovation and improve the predictability, consistency, and transparency of its decisionmaking.^[1] 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.

The report proposes actions CDRH might take to help accelerate the development and regulatory evaluation of innovative devices safely and based on sound science. These actions are as follows:

• Facilitate the development and regulatory evaluation of innovative medical devices;
• Strengthen the U.S. research infrastructure and promote high-quality regulatory science; and
• Prepare for and respond to transformative innovative technologies and scientific breakthroughs.

Part of the Medical Device Innovation Initiative would consider the creation of a special Innovation Pathway intended to provide earlier investment of CDRH time and resources in devices that are true pioneering technologies and that have the potential to revolutionize patient care or health care delivery. By front-loading critical aspects, such as identifying clinical endpoints and key scientific questions, and seeking advice from external experts, the Innovation Pathway would facilitate a more efficient regulatory review process for transformative devices.

CDRH is seeking public comment on the proposals contained in the report through an open public docket and will be hosting a public meeting to solicit stakeholder feedback at our White Oak, MD campus on March 15, 2011. Therefore, elsewhere in this issue of the Federal Register, FDA is announcing a public meeting entitled “CDRH's Medical Device Innovation Initiative Public Workshop.”

CDRH requests public comments on the report in general, as well as the following specific questions and topics:

1. The eligibility criteria for the Innovation Pathway.

2. How should CDRH determine what types of technology should be allowed into the Innovation Pathway and at what point they should no longer be accepted as innovative products? For example, under Expedited Review, if multiple applications for the same type of device offering comparable advantage over existing approved alternatives have been granted expedited review, they are reviewed with priority assigned on a first-in-first-reviewed basis for each review cycle. Furthermore, if one of these applications is approved, the remaining expedited applications will retain their expedited status until a final decision is rendered after which point no additional devices of this type will be granted expedited review status. Should the same process be used for the Innovation Pathway?

3. What are the appropriate timeframes for review of submissions under the Innovation Pathway? Should final regulatory submissions from devices developed under the Innovation Pathway be reviewed on a shortened timeframe? For comparison, the review times to which CDRH has currently committed under the Medical Device User Fee and Modernization Act are available at: http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Overview/​MedicalDeviceUserFeeandModernizationActMDUFMA/​ucm109319.htm.

4. Criteria for clinical test center certification.

5. Candidates for interagency or public-private partnerships to foster medical device innovation.

6. Other actions CDRH should take to facilitate the development, assessment, and regulatory review of innovative medical devices while assuring their safety and effectiveness.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the report at http://www.regulations.gov or http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​ucm241095.htm.

Dated: February 4, 2011.

Nancy K. Stade,

Deputy Director, Center for Devices and Radiological Health.

Footnotes

1.  See “510(k) and Science Report Recommendations: Summary and Overview of Comments and Next Steps,” available at http://www.fda.gov/​downloads/​AboutFDA/​CentersOffices/​CDRH/​CDRHReports/​UCM239449.pdf;​; and “Plan of Action for Implementation of 510(k) and Science Recommendations,” available at http://www.fda.gov/​downloads/​AboutFDA/​CentersOffices/​CDRH/​CDRHReports/​UCM239450.pdf.