Food and Drug Administration, HHS.
Proposed order; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. All other class II devices classified under FDA's surgical apparel classification regulation would continue to be subject to premarket notification requirements. FDA is publishing this document to obtain comments regarding this proposed exemption, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Submit either electronic or written comments by January 29, 2018.
You may submit comments as follows:
Submit electronic comments in the following way. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 29, 2018. The
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• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
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• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
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Aftin Ross, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5402, Silver Spring, MD 20993, 301–796–5679, email:
Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part 807 subpart E, require persons who intend to market a new device to submit and obtain clearance of a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device that does not require premarket approval.
The 21st Century Cures Act (Pub. L. 114–255) (Cures Act) was signed into law on December 13, 2016. Section 3054 of the Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(2) of the FD&C Act provides that, 1 calendar day after the date of publication of the final list under paragraph (1)(B), FDA may exempt a class II device from the requirement to submit a report under section 510(k) of the FD&C Act upon its own initiative or a petition of an interested person, if FDA determines that a report under section 510(k) is not necessary to assure the safety and effectiveness of the device. To do so, FDA must publish in the
There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998,
FDA, on its own initiative, is proposing to exempt N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) from 510(k), subject to the conditions and limitations described in this section. FDA considers both of these devices to be a subset of “surgical apparel” intended to be worn by healthcare personnel to protect both the patient and the healthcare personnel from transfer of microorganisms, body fluids, and particulate material. As a result, these devices fall under the generic name “surgical apparel” and are classified in 21 CFR 878.4040(b)(1). In the
FDA has a Memorandum of Understanding (MOU) with the Centers for Disease Control and Prevention (CDC), acting through its National Institute for Occupational Safety and Health (NIOSH) regarding oversight of N95s (Ref. 2). This agreement outlines the structure through which both Agencies will regulate N95s being proposed for exemption from 510(k). However, this MOU will not be effective unless and until, FDA publishes an order in the
Although FDA and CDC share a common public health mission, the Agencies have different statutory authorities and the distinct terminology could lead to confusion among stakeholders. In order to clearly identify the devices that are subject to this document, as well as the corresponding MOU, the following definitions are provided for the devices being proposed for exemption.
The N95 FFR is a single-use disposable, half-mask respiratory protective device that covers the user's airway (nose and mouth) and offers protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181. Such an N95 FFR used in a healthcare setting is a class II device, regulated by FDA under 21 CFR 878.4040.
The surgical N95 respirator is a single-use, disposable respiratory protective device used in a healthcare setting that is worn by HCP during procedures to protect both the patient and HCP from the transfer of microorganisms, body fluids, and particulate material at an N95 filtration efficiency level per 42 CFR 84.181. The surgical N95 respirator is also a class II device, regulated by FDA under 21 CFR 878.4040.
As described in the MOU, the following conditions must be met for N95s to be 510(k) exempt: (1) Application submitted to NIOSH is determined not to exceed the CDC and
N95s are the only devices included within the scope of the MOU. As such, this proposed exemption would only apply to devices currently regulated by FDA under product code MSH. If finalized, this exemption would not affect any other subset of surgical apparel classified under 21 CFR 878.4040. In addition to being subject to the general limitations to the exemptions found in 21 CFR 878.9 and the conditions of exemption identified in this document, these devices will also remain subject to current good manufacturing practices and other general controls under the statute. An exemption from the requirement of 510(k) does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation.
The following references are on display in the Dockets Management Staff (see
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(b) * * *
(1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (
(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.