Source: https://www.federalregister.gov/articles/2013/01/08/2013-00086/anesthesiology-devices-reclassification-of-membrane-lung-for-long-term-pulmonary-support
Timestamp: 2015-08-02 14:24:38
Document Index: 494664700

Matched Legal Cases: ['art 868', 'art 870', 'arts 868', 'art 868', '§ 868', '§ 868', 'ART 870', 'art 870', '§ 870', '§ 870']

Federal Register | Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Pulmonary/Cardiac Support
78 FR 1158
-1162 (5 pages)
Shorter URL: https://federalregister.gov/a/2013-00086 Related Topics
FDA-2012-N-1174
You may submit comments, identified by Docket No. FDA-2012-N-1174, by any of the following methods:
Instructions: All submissions received must include the Agency name and Docket No. FDA-2012-N-1174 for this order. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.
The FD Act, as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (94), the Safe Medical Devices Act of 1990 (101), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act of 2004 (Pub. L. 108- 214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).
Section 513(e) of the FD&C Act governs reclassification of preamendments devices. This section provides that FDA may, by administrative order, reclassify a device (in a proceeding that parallels the initial classification proceeding) based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify a preamendments device. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., Holland Rantos v. United States Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously before the Agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 389-391 (D.D.C. 1991)) or in light of changes in “medical science.” (See Upjohn v. Finch, supra, 422 F.2d at 951.) Whether data before the Agency are past or new data, the “new information” to support reclassification under section 513(e) must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985).)
FDA relies upon “valid scientific evidence” in the classification process to determine the level of order for devices. To be considered in the reclassification process, the valid scientific evidence upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending premarket approval application (PMA). (See section 520(c) of the FD Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD Act, added by FDAMA, provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety or effectiveness of the device but does not include descriptions of methods of manufacture or product composition and other trade secrets.
No comments were received on the proposed rule and on July 16, 1982 (47 FR 31130), a final rule was published for membrane lungs for long-term pulmonary support, classifying these devices as class III. In 1987, FDA published a final rule amending the codified language for this device to clarify that no effective date had been established for the requirement for premarket approval for membrane lungs for long-term pulmonary support devices (52 FR 17732 at 17735; May 11, 1987). In 2009, FDA published an order under sections 515(i) and 519 of the FD Act (21 U.S.C. 360e and 360i) for the submission of safety and effectiveness information on a membrane lung for long-term pulmonary support (74 FR 16214; April 9, 2009). In response to that order, FDA received information from one device manufacturer.
A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as an ECMO. An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. The circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump, cannulae, heat exchanger, tubing, filters, monitors/detectors, and other accessories; the circuit components and configuration (e.g., arteriovenous, veno-venous) may differ based on the needs of the individual patient or the condition being treated. ECMO is intended for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management.
FDA believes that the identified special controls, in addition to general controls, are necessary to provide reasonable assurance of safety and effectiveness. Therefore, in accordance with sections 513(e) and 515(i) of the FD Act and 21 CFR 860.130, based on new information with respect to the devices, FDA, on its own initiative, is proposing to reclassify this preamendments class III device into class II. The Agency has identified special controls under section 513(a) of the FD Act that would provide reasonable assurance of their safety and effectiveness. The new information includes the history of use of the circuit components, publicly available safety and effectiveness information (as described in Section VII of this document) and the relatively low incidence of adverse events, as discussed in the recommendations for reclassification from the device industry (available in docket FDA-2009-M-0101 at http://www.regulations.gov). FDA believes that this information is sufficient to demonstrate that the proposed special controls can effectively mitigate the risks to health identified in section V of this document and that these special controls, in addition to the general controls, will provide a reasonable assurance of safety and effectiveness for ECMO devices.
FDA believes that extracorporeal circuits and accessories for long-term pulmonary/cardiac support should be reclassified into class II because special controls, in addition to general controls, can be established to provide reasonable assurance of the safety and effectiveness of the device. In addition, there is now adequate effectiveness information sufficient to establish special controls to provide such assurance for conditions where imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery.
FDA is proposing to rename this device to “Extracorporeal circuit and accessories for long-term pulmonary/cardiac support”; the current classification regulation for this device is referred to as “membrane lung for long-term pulmonary support.” For clarity, the new title for this proposed order will be removed from 21 CFR part 868 and redesignated to 21 CFR part 870. Section 870.4100 will be added to reflect all device components used in ECMO.
Since the time of the Panel recommendation, sufficient evidence has been developed to support a reclassification of extracorporeal circuits and accessories for long-term pulmonary/cardiac support to class II with special controls for conditions where imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery. FDA is familiar with the risks associated with the use of the components of the extracorporeal circuit because the same components are used for short-term use (durations less than 6 hours) for cardiopulmonary bypass. In addition, the Extracorporeal Life Support Organization registry data (Ref. 1), which provides information on over 28,000 ECMO procedures performed since 1987, and reviews of institutional experience (Ref. 2) demonstrate a favorable benefit-risk profile for extracorporeal circuits and accessories when used for conditions where imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery.
1. Fleming, G. M., J. G. Gurney, J. E. Donahue, et al., “Mechanical Component Failures in 28,171 Neonatal and Pediatric Extracorporeal Membrane Oxygenation Courses From 1987 to 2006,”Pediatric Critical Care Medicine Journal, vol. 10, pp. 439-444, July 2009.
2. Cook, L. N., “Update on Extracorporeal Membrane Oxygenation,”Paediatric Respiratory Reviews, vol. 5, suppl. A, pp. S329-S337, 2004.
List of Subjects in 21 CFR Parts 868 and 870 Back to Top
1.The authority citation for 21 CFR part 868 continues to read as follows: Authority:
§ 868.5610 [Removed]
2.Remove § 868.5610. PART 870—CARDIOVASCULAR DEVICES Back to Top
3.The authority citation for 21 CFR part 870 continues to read as follows: Authority:
4.Add § 870.4100 to subpart E to read as follows: § 870.4100 Extracorporeal circuit and accessories for long-term pulmonary/cardiac support.
(3) Sterility and shelf life testing must demonstrate the sterility of patient- contacting components and the shelf-life of these components;
[FR Doc. 2013-00086 Filed 1-7-13; 8:45 am]