Source: https://www.federalregister.gov/documents/2013/01/08/2013-00086/anesthesiology-devices-reclassification-of-membrane-lung-for-long-term-pulmonary-support
Timestamp: 2017-05-25 16:32:28
Document Index: 19551186

Matched Legal Cases: ['§\u2009868', 'art2', '§\u2009868', 'art4', '§\u2009870', '§\u2009870']

:: Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Pulmonary/Cardiac Support
2013-00086
Reference 2A, FDA Executive Summary Circulatory System Devices...
Reference 2, Circualtory System Devices Panel Meeting...
Reference 1A, FDA Executive Summary Circulatory System Devices...
Reference 1, Circulatory System Devices Panel Meeting...
Reference List re Anesthesiology Devices; Reclassification of...
https://www.federalregister.gov/d/2013-00086
The FD&C Act, as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), 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-Start Printed Page 1159214), 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&C 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).
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&C 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&C Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD&C 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&C 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 Start Printed Page 1160not 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.
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 Start Printed Page 1161where 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.
§ 868.5610 [Removed]
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Start Amendment Part4. Add § 870.4100 to subpart E to read as follows:End Amendment Part
§ 870.4100 Extracorporeal circuit and accessories for long-term pulmonary/cardiac support.
(3) Sterility and shelf life testing must demonstrate the sterility of patient-Start Printed Page 1162contacting components and the shelf-life of these components;