Source: https://www.federalregister.gov/documents/2007/07/03/E7-12789/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-filtering-facepiece
Timestamp: 2019-09-22 03:53:55
Document Index: 10855913

Matched Legal Cases: ['art 84', 'art 84', 'art 84', 'art 84', '§\u2009880', 'art 84', '§\u2009880']

Federal Register :: Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies
Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies
A Rule by the Food and Drug Administration on 07/03/2007
This rule is effective August 2, 2007. The classification was effective May 8, 2007.
36360-36363 (4 pages)
Docket No. 2007N-0198
https://www.federalregister.gov/d/E7-12789 https://www.federalregister.gov/d/E7-12789
The Food and Drug Administration (FDA) is classifying the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of these devices and is specifying what those special controls are.
Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies.” This guidance document will serve as one of the special controls, along with certification of the respirator by the National Institute for Occupational Safety and Health (NIOSH) in accordance with its regulations for non-powered air-purifying particulate respirators, found in 42 CFR part 84, as specified in the classification regulation.
Sheila A. Murphey, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3700.
In accordance with section 513(f)(1) of the act, FDA issued an order on August 30, 2006, classifying the two 3M filtering facepiece respirators intended for use by the general public in public health medical emergencies (designated at that time as the 3MTM N95 Home Respirator with Fluid Resistance and 3MTM N95 Home Respirator) in class III, because each device was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device that was subsequently reclassified into class I or class II. On October 3, 2006, 3M Inc. submitted a petition requesting initial classification of these devices under section 513(f) (2) of the act. The manufacturer recommended that the Start Printed Page 36361devices be classified into class II (Ref. 1). In response to FDA requests for additional information, 3M supplemented its petition on March 22, 2007.
In accordance with section 513(f) (2) of the act, FDA reviewed the petition in order to classify the devices 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 and its supplements, FDA determined that the 3MTM filtering facepiece respirator devices, now known as the 3MTM 8612F Respirator for Use by the General Public in Public Health Medical Emergencies and 3MTM 8670F Respirator for Use by the General Public in Public Health Medical Emergencies 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 the device and that there is sufficient information to establish special controls to provide such assurance.
The device is assigned the generic name “Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies” and is identified as a device that is a disposable half-facepiece non-powered air-purifying particulate respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency. The device is made of polymeric materials and is intended to fit closely to the face and to function by filtering particulate material.
For this type of respirator to reduce wearer exposure to pathogenic biological airborne particulates, it must be made of filter material that is highly efficient in filtering such particles. At the same time, because this type of device depends on the wearer's normal respiration to draw ambient air through the respirator materials and into the lungs, the respirator material must also permit adequate respiration.
The device must fit closely to the wearer's face without any gaps that would allow air to reach the wearer's respiratory tract without passing through the filter material. Otherwise, improper fit of the respirator could result in inhalation of pathogenic biological airborne particulates carried in air that passes around the sides of the device.
For users with certain underlying cardiac, pulmonary or related medical conditions, achieving the fit necessary to help reduce their exposure to pathogenic biological airborne particulates may exacerbate their underlying medical conditions raising a concern about their safe use for these populations.
Finally, these respirators have not been established to be safe or effective if reused, and use of a single respirator by multiple users may result in the respirator itself becoming a vector of transmission.
To address these issues, the class II special controls guidance document provides recommendations for labeling and for information to be provided to meet premarket notification (510(k)) submission requirements for the device, including recommendations for fit testing and biocompatibility testing. In addition, this classification regulation specifies another special control, certification of the respirator by NIOSH as a non-powered air-purifying particulate respirator with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84. The respirators that were the subject of the initial classification order described in this document and that are the initial legal predicate devices for this new device classification were certified by NIOSH under these requirements, as revised as of October 1, 2006. FDA's determination that NIOSH certification is an appropriate special control to help assure the safety and effectiveness of the respirator for its intended use under this classification rests on the assurance of filtration efficiency and breathability provided by NIOSH certification under these requirements, as effective on May 8, 2007, the date of FDA's classification order. Should NIOSH revise the requirements for certification in the future, FDA will evaluate whether certification under such revised NIOSH regulations is an appropriate special control for devices within this classification and may revise FDA's regulation using appropriate procedures.
FDA believes that these special controls, designated in this rule, in addition to general controls, address the issues identified previously and provide reasonable assurance of the safety and effectiveness of the device type. Thus, on May 8, 2007, FDA issued an order to the petitioner classifying the device type into class II. FDA is codifying this classification at 21 CFR 880.6260.
Following the effective date of the final classification rule, manufacturers will need to demonstrate NIOSH certification of any filtering facepiece respirator for use by the general public in public health medical emergencies, Start Printed Page 36362as set forth in 21 CFR 880.6260(b)(1), and address the issues covered in the special controls guidance. With respect to the issues addressed only in the special control 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. For filtering facepiece respirators for use by the general public in public health medical emergencies, however, FDA has determined that premarket review of fit performance data, labeling, and other requirements as outlined in 21 CFR 807.87, is necessary to provide reasonable assurance that acceptable levels of performance for both safety and effectiveness will be addressed before marketing clearance. Thus, persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device type.
This final rule contains no new information collection provisions but refers to NIOSH regulations in 42 CFR part 84 that contain information collection provisions that have been reviewed and approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), under OMB Control No. 0920-0109. Based on information from NIOSH regarding submissions for respirator certification received in the past 3 years, FDA concludes that specification of NIOSH certification as a special control will not result in the collection of any additional information by NIOSH not already covered by NIOSH's burden estimates. This final rule also designates a guidance document as a special control. Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the availability of that guidance document, “Class II Special Controls Guidance Document: Filtering Facepiece Respirators for Use by the General Public in Public Health Medical Emergencies,” which contains a Paperwork Reduction Act analysis for that guidance.
1. Petition from 3M.
2. 42 CFR part 84, as revised as of October 1, 2006.
2. Section 880.6260 is added to subpart G to read as follows:
§ 880.6260
(1) Certification by the National Institute for Occupational Safety and Health (NIOSH) as a non-powered air-Start Printed Page 36363purifying particulate respirator with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84.
(2) The FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies.” See § 880.1(e) for information on obtaining a copy of this guidance document.
[FR Doc. E7-12789 Filed 7-2-07; 8:45 am]