Public notice for FDA Panel on Digital Pathology

| October 1, 2009

Public notice for FDA panel was published in the Federal Register. Will keep you posted on what comes of this meeting – it should be interesting.  My personal feeling is I do not know how far the FDA will go in terms of formal clearances for devices such as whole slide scanners, particularly since these technologies are based on conventional light microscopy principles and these devices are not cleared, nor can they be.  Also the nuances of "lesion" is broad and starts long before an image is created – biopsy, fixation, processing, cutting, staining, coverslipping and finally review or scan and review.  Controlling for all of this plus the actual diagnosis may make validation difficult.  Wrangling with this very issue in my own shop with digital review of extramural cases.
Abridged meeting notification below.

Food and Drug Administration

Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting will be open to the public.

Name of Committee: Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee:  To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time:  The meeting will be held on October 22 and 23, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy, Gaithersburg, MD.

Contact Person: Louise E. Magruder, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6175, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512515.  Please call the Information Line for up-to-date information on this meeting.  A notice in the FEDERAL REGISTER about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

    Agenda: On October 22 and 23, the committee will discuss and make recommendations on public health issues related to the use of digital whole slide imaging systems to replace conventional light microscopy for diagnostic surgical pathology.  In the scope of this meeting, digital pathology is defined as converting what can be observed by conventional light microscopy on histologic glass slides into digital whole slide images via digital scanners; viewing these images via a computer monitor to render pathologic diagnosis of the lesion of interest; and digitally archiving and retrieving these images.   The committee will not be discussing computer-assisted image analysis or remote real-time microscopy.

    FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.  Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm, click on the year 2009 and scroll down to the appropriate advisory committee link.

    Procedure:  Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person on or before October 15, 2009.  Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. each day.  Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 1, 2009.  Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by October 8, 2009.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, 301-796-5966 at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings.  Please visit our Web site at http://www.fda.gov/oc/AdvisoryCommittee/AboutAdvisortCommittee/ucm111462.htm for procedures on public conduct during advisory committee meetings.


Category: Digital Pathology News, Pathology News

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