[Federal Register Volume 71, Number 159 (Thursday, August 17, 2006)]
[Notices]
[Pages 47499-47500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13509]


-----------------------------------------------------------------------

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