Source: https://www.federalregister.gov/documents/2011/07/26/2011-18806/medical-devices-neurological-devices-classification-of-repetitive-transcranial-magnetic-stimulation
Timestamp: 2017-02-28 14:31:09
Document Index: 686561209

Matched Legal Cases: ['art 807', 'art 807', '§\u2009882', 'art2', '§\u2009882', '§\u2009882']

:: Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic Stimulation System
A Rule by the Food and Drug Administration on 07/26/2011
44489-44491
https://www.federalregister.gov/d/2011-18806
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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, 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 the device is classified or reclassified into class I or class II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act (21 U.S.C. 360c(i)), to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of FDA's regulations (21 CFR part 807).
FDA believes that the class II special controls guidance document will aid in Start Printed Page 44490mitigating the potential risks to health as described in table 1 of this document.
Table 1—Risks to Health and Mitigation MeasuresIdentified riskMitigation measuresFailure to identify correct patient populationClinical testing. Labeling.Ineffective treatmentNonclinical analysis and testing. Software life cycle and risk management. Clinical testing. Labeling.SeizureNonclinical analysis and testing. Clinical testing. Labeling.Scalp discomfort, scalp burn, or other adverse effectsNonclinical analysis and testing. Software life cycle and risk management. Clinical testing. Labeling.Magnetic field effects on functioning of other medical devicesNon-clinical analysis and testing. Labeling.Adverse tissue reactionBiocompatibility.Hazards associated with electrical equipmentElectrical equipment safety. Labeling.Hazards caused by electromagnetic interference and electrostatic discharge hazardsElectromagnetic compatibility. Labeling.Hearing lossLabeling.
FDA believes that the special controls, in addition to general controls, address the risks to health identified previously in this document and provide reasonable assurances of the safety and effectiveness of the device type. Thus, on October 7, 2008, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying this classification by adding § 882.5805.
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 FD&C Act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under Start Printed Page 44491the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from or in addition to” certain Federal requirements applicable to devices. 21 U.S.C. 360k. See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The special controls established by this final rule create “requirements” to address each identified risk to health presented by these specific medical devices under 21 U.S.C. 360k, even though product sponsors may have flexibility in how they meet those requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997).
Start Amendment Part2. Section 882.5805 is added to subpart F to read as follows:End Amendment Part
§ 882.5805
(b) Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.