[Federal Register: August 17, 2006 (Volume 71, Number 159)]
[Notices]
[Page 47499-47500]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au06-53]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Heparin Catheter Lock-Flush Solutions; Transfer of Primary
Responsibility from Center for Drug Evaluation and Research to Center
for Devices and Radiological Health
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; announcement of transfer.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
transfer of primary responsibility for the regulation of heparin
catheter lock-flush solution products from the Center for Drug
Evaluation and Research (CDER) to the Center for Devices and
Radiological Health (CDRH). These products are combination drug-device
products. The transfer of lead review responsibility to CDRH is based
on FDA's determination that the primary mode of action for these
heparin catheter lock-flush solution products is that of the device
part of the combination. The transfer provides consistency and
efficiency in the regulation of these combination products by treating
like products similarly.
DATES: The effective date of the transfer is October 16, 2006.
FOR FURTHER INFORMATION CONTACT:
For information regarding this notice: James S. Cohen, Office of
the Commissioner (HFG-3), Food and Drug Administration, 15800 Crabbs
Branch Way, Rockville, MD 20855, 301-427-1934.
For questions on what to submit in the 510(k) submission: Sheila A.
Murphe, Center for Devices and Radiological Health (HFZ-480), Food and
Drug Administration, 9200 Corporate Blvd., rm. 350AA, Rockville, MD
20850, 301-443-8913, ext. 203.
SUPPLEMENTARY INFORMATION: Heparin catheter lock-flush solution
products are intended to enhance the performance of intravascular
catheters. An intravascular catheter is a device that consists of a
slender tube and any necessary connecting fittings that are inserted
into a patient's vascular system for short-term use (less than 30 days)
to sample blood, monitor blood pressure, or administer fluids
intravenously. Heparin catheter lock-flush solutions are periodically
inserted into and stored within the catheter to keep the catheter
patent and to prevent blood from clotting within the catheter between
uses.
Prior to the mid-1990's, heparin catheter lock-flush solution
products were regulated under the new drug and abbreviated new drug
provisions of the Federal Food, Drug, and Cosmetic Act (the act), with
CDER serving as the lead agency review component. Many of the available
marketed products were approved under abbreviated new drug applications
(``generic drugs''). However, more recently, based on several
jurisdictional determinations by FDA for specific products,
applications for catheter lock-flush solutions containing
anticoagulant, such as heparin, or antimicrobial components have been
assigned to CDRH and regulated under the device provisions of the act.
FDA is now transferring the applications for heparin catheter lock-
flush solution products that are in CDER to reflect these more current
jurisdictional determinations.
Heparin catheter lock-flush solutions are intended to maintain
patency when the catheter is not being used to sample blood, monitor
blood pressure, or administer fluids to the patient. The solution
component of the product (i.e., sterile saline or sterile water) acts
by physically occupying space within the intravenous catheter and
exerting pressure on the patient's circulating blood. This action helps
to prevent the patient's blood from backfilling into the catheter,
clotting, and contributing to microbial contamination. When acting in
this way, the solution meets the definition of a device in the act in
that it affects the structure or function of the body, and does not
achieve its primary intended purposes through chemical or metabolic
action (21 U.S.C. 321(h)). Likewise, the heparin (i.e. the
anticoagulant) component of the product meets the definition of a drug
in that it is intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man, and is intended to affect
the structure or function of the body of man (21 U.S.C. 321(g)).
Catheter lock-flush solutions that contain both drug and device
components are combination products as defined in 21 CFR 3.2(e)(1). FDA
is responsible for assigning combination products to a lead agency
Center for regulation based upon the agency's determination of the
combination product's ``primary mode of action.'' (See 21 U.S.C.
353(g)(1) and 21 CFR 3.4.) FDA has determined that the primary mode of
action of heparin catheter lock-flush solution products in maintaining
catheter patency is attributable to the device component's role in
physically occupying space and applying pressure within the catheter.
[[Page 47500]]
FDA likewise has determined that the drug component of the product
(heparin) performs a secondary role by acting chemically to prevent
thrombotic occlusions within the catheter.
Accordingly, to enhance consistency and efficiency in the
regulation of these combination products by treating like products
similarly, FDA is transferring primary review responsibility from CDER
to CDRH for heparin catheter lock-flush solution products that have
been regulated under the drug provisions of the act. The transferred
products will be reviewed and regulated under the device provisions of
the act. As with all combination products, CDRH will consult with CDER
regarding the drug components of these products as appropriate.
Catheter lock-flush solutions that contain only water or saline are
considered devices rather than combination products and are regulated
under the device provisions of the act.
The agency intends to assist manufacturers of currently marketed
heparin catheter lock- flush solution products in the transition from
approved new drug applications (NDAs) or approved abbreviated new drug
applications (ANDAs) to 510(k) submissions under the device provisions
of the act. Based upon the submissions made and the prior review of
these products under the drug provisions of the act, FDA has determined
that heparin catheter lock-flush solution products approved under these
particular approved NDAs or ANDAs are substantially equivalent to
heparin catheter lock-flush solution products cleared for marketing
under section 510(k) of the act (21 U.S.C. 360(k)) and the approved
NDAs or ANDAs will be considered cleared device premarket notifications
(510(k) clearances) under section 510(k) when FDA has provided the
sponsor written notification of the transfer and its effective date. No
application user fees will be assessed for this administrative
transfer. NDA and ANDA manufacturers that have previously notified FDA
(i.e. before the date of this notice) that they have discontinued
marketing their heparin catheter lock-flush solution products will be
subject to review and clearance of a 510(k) submission prior to
marketing their product again.
Heparin catheter lock-flush solution products are accessories to,
and regulated along with, intravascular catheters as Class II devices
(special controls). (See 21 CFR 880.5200.) Upon the effective date of
the transfer, the transferred products will be subject to the
provisions of section 510(k) of the act and its implementing
regulations (part 807 (21 CFR part 807)). The transferred products will
be subject to the general control provisions of section 513 of the act,
including the Registration and Listing regulation (part 807), the
Quality System Regulation (part 820 (21 CFR part 820)), and the Medical
Device Reporting regulation (21 CFR part 803).
Manufacturers planning to change or modify the design, components,
method of manufacture, or intended use of a transferred heparin
catheter lock-flush solution product should evaluate whether a 510(k)
submission is required for the change or modification as set forth in
Sec. 807.81(a)(3). If a 510(k) submission is required, the
manufacturer should cite in its initial submission the NDA or ANDA
number held for the product and include a copy of the letter sent from
FDA notifying the sponsor of the transfer of review responsibility to
CDRH.
FDA finds that there is a substantial likelihood that failure to
comply with the Quality System Regulation (part 820) for this product
will potentially present a serious risk to human health. Therefore,
future 510(k) submissions for heparin catheter lock-flush solution
products will be subject to pre-clearance inspections in accordance
with section 513(f)(5) of the act (21 U.S.C. 360c).
FDA will contact applicants holding approved NDAs or ANDAs that it
believes have products affected by this transfer. Holders of
applications subject to transfer, holders of applications for
discontinued heparin catheter lock-flush solutions products, or holders
of applications for catheter lock-flush solution products with other
ingredients who are uncertain as to which agency Center has primary
jurisdiction, should contact James S. Cohen (see the FOR FURTHER
INFORMATION CONTACT section).
Dated: August 9, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-13509 Filed 8-16-06; 8:45 am]
BILLING CODE 4160-01-S