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October 10, 2008

Via Electronic Submission

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD 20852

**Re: Docket No. FDA-2006-N-0178; Comments on Proposed Reclassification
of**

> **"Absorbable Hemostatic Device" and Draft Guidance Document**

Dear FDA:

DuPont BioMedical (DuPont) appreciates the opportunity to submit
comments on FDA's proposed reclassification of "absorbable hemostatic
devices" (21 C.F.R. § 878.4490) and the corresponding draft guidance
document. 73 *Fed. Reg*. 52804 and 52861 (September 11, 2008) (reopening
of comment period). DuPont is capitalizing on the company's materials
expertise to serve the medical community by introducing products that
are intended to be safer, more effective, and easier to use than current
alternatives.

DuPont generally supports the proposed reclassification of devices
covered only by product codes "LMF" (absorbable hemostatic agent,
collagen based) and "LMG" (absorbable hemostatic agent, not collagen
based). See Draft Guidance, Section 4, page 6. However, DuPont
recommends that FDA clarify which mechanism(s) of action would not be
covered by the new regulation. Specifically, under the proposed
classification regulation, an absorbable hemostatic device is one
intended to "produce hemostasis by accelerating the clotting process of
the blood." Proposed 21 C.F.R. § 878.4490(a); 71 Fed. Reg. 63728, 63732
(October 31, 2006). The description of this action is extremely broad
and could be read to cover a wide variety of products (potentially
covering new technologies). However, during the early stages of the
reclassification process, FDA personnel suggested that devices that
function only as a tamponade should be excluded from the reclassified
definition.

Specifically, at the meeting of the General and Plastic Surgery Devices
Advisory Committee (Panel) on July 24, 2003, FDA's Dr. David Krause
suggested that products that simply block bleeding were not intended to
be covered. In discussing the scope of the new definition, Dr. Krause
stated as follows: "\[B\]one wax doesn\'t meet that definition \[of
absorbable hemostatic agent\] because it does not accelerate clotting.
It merely acts as a tamponade. It just blocks bleeding. It doesn\'t
really induce hemostasis, which these \[other\] products do."[^1]
Although there was a brief discussion about terminology, the Panel
appeared to endorse Dr. Krause's view.[^2]

For consistency, DuPont recommends that FDA clarify the discussion in
the regulation and guidance to make clear that products that do not
initiate or interact with the clotting cascade are outside the scope of
the new regulation. This will ensure that the regulation is in line with
the Agency's past understanding of the types of devices covered.

\* \* \*

DuPont appreciates the opportunity to submit comments on FDA's proposed
reclassification of absorbable hemostatic devices. Please feel free to
contact me if you need additional information.

Sincerely,

Howard Mann

Regulatory Affairs Manager

[^1]: Meeting Transcript, page 139 (available at:
    (http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3973t1.doc).

[^2]: Meeting transcript, page 140.