E7-1566. Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled “Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container.” FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

DATES:

This rule is effective March 5, 2007. The classification of this device into class II became effective on January 3, 2007.

FOR FURTHER INFORMATION CONTACT:

Denise Sánchez, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976 (the amendments), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. FDA determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807 of FDA's regulations.

Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification (section 513(f)(2) of the act).

In accordance with section 513(f)(1) of the act, FDA issued an order on October 6, 2006, classifying into class III the Biosafe SA Sepax Cell Separation System and single use kits because this device is not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or to a device which was subsequently reclassified into class I or class II. On November 1, 2006, Biosafe SA submitted to FDA a petition requesting classification of the Sepax Cell Separation System and single use kits under section 513(f)(2) of the act. The manufacturer recommended that the device be classified into class II (Ref. 1).

In accordance with 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in 513(a)(1) of the act. Devices are to be classified into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the Biosafe SA Sepax Cell Separation System and single use kits, when used in the processing and the storage of cord blood, can be classified into class II with the establishment of special controls. FDA believes that special controls, in addition to general controls, are adequate to provide reasonable assurance of the safety and effectiveness of this device and that there is sufficient information to establish special controls to provide such assurance.

This device is assigned the generic name “cord blood processing system and storage container.” It is identified as a device intended for use in the processing and the storage of cord blood. This device is a functionally closed processing system that includes containers, other soft goods, and a centrifugation system for cord blood concentration, and a final container for the cryopreservation and the storage of a cord blood product.

FDA has identified the risks to health associated with the use of a cord blood processing system and storage container. These risks include lack of biocompatible components; toxicity of residual chemical sterilants used to sterilize device components; toxicity of leached materials from or that permeate through plastic device components; insufficient mechanical strength of device containers, tubing, and seals resulting in integrity failure of the device; contamination; instability of soft goods over time; physical damage to or loss of the cord blood product; software failure; operator/user injury; electromagnetic interference; and electrical hazards.

FDA believes that the class II special controls guidance document will aid in mitigating the potential risks to health by providing recommendations for describing the device, validating performance characteristics, and labeling. The guidance document provides recommendations for fulfilling the premarket (510(k)) submission requirements for this device. FDA believes that the special controls guidance document, in addition to general controls, addresses the risks to health identified in the previous paragraph and provides reasonable assurance of the safety and effectiveness of a cord blood processing system and storage container. Therefore, on January 3, 2007, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying this device classification at 21 CFR 864.9900.

Following the effective date of this final classification rule, manufacturers submitting a 510(k) premarket notification for a cord blood processing system and storage container will need to address the issues covered in the special controls guidance. However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurance of safety and effectiveness.

Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of this type of device and, therefore, this type of device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, before marketing the device, which contains information about the cord blood processing system and storage container they intend to market.

II. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because classification of this device into class II will relieve manufacturers of the cost of complying with the premarket approval requirements of section 515 of the act (21 U.S.C. 360e), and will not constitute a potential barrier to small competitors that may wish to enter the market in the future, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current (2005) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

III. Environmental Impact

The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

IV. Federalism

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, FDA has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

V. Paperwork Reduction Act of 1995

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 is not required. Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the availability of the guidance document entitled “Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container.” FDA concludes that the special controls guidance document contains information collection provisions that are subject to review by the OMB under the PRA and that have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E; OMB Control No. 0910-0120).

VI. Reference

The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Petition from Biosafe SA for the classification of the Sepax Cell Separation System and single use kits into class II (special controls), dated November 1, 2006.

List of Subjects in 21 CFR Part 864

• Blood
• Medical devices
• Packaging and containers

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 864 is amended as follows:

PART 864—HEMATOLOGY AND PATHOLOGY DEVICES

1. The authority citation for 21 CFR part 864 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

2. Add subpart K, consisting of § 864.9900, to read as follows:

Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

§ 864.9900

Cord blood processing system and storage container.

(a) Identification. A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is a functionally closed processing system that includes containers, other soft goods, and a centrifugation system for cord blood concentration, and a final container for the cryopreservation and the storage of a cord blood product.

(b) Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container.” For the availability of this guidance document, see § 864.1(d).

Dated: January 24, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.