Archive for June, 2008
Medical Devices; Hearing Aids; Technical Data Amendments
Jun 02, 2008 (Food and Drug Administration Documents and Publications/ContentWorks via COMTEX) — – SUMMARY: The Food and Drug Administration (FDA) is amending its regulations governing hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. We are amending the regulations to require that manufacturers may use state-of-the-art methods to provide technical data in hearing aid labeling. FDA is also amending the regulations to update an address and remove an outdated requirement. FDA is amending the regulations in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA’s usual procedures for notice and comment rulemaking to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.
DATES: This rule is effective October 15, 2008. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in SEC 801.420(c)(4) (21 CFR 801.420(c)(4)) as of October 15, 2008. Submit written or electronic comments by August 18, 2008. If we receive no significant adverse comments within the specified comment period, we intend to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If we receive any timely significant adverse comment, we will withdraw this final rule in part or in whole by publication of a document in the Federal Register within 30 days after the comment period ends.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-N-0148, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
* Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
* FAX: 301-827-6870.
* Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously, in the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name and Docket No. for this rulemaking. 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.
Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Eric A. Mann, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4242.
SUPPLEMENTARY INFORMATION:
I. What Is the Background of the Rulemaking?
In the Federal Register of February 15, 1977 (the 1977 final rule) (42 FR 9286), FDA published a final rule establishing requirements for professional and patient labeling of hearing aids and governing conditions for sale of hearing aids ( SEC 801.420 and SEC 801.421 (21 CFR 801.421)). The regulations became effective on August 15, 1977. Section 801.421(b)(1) of the current regulations provides that, before the sale of a hearing aid to a prospective user, a hearing aid dispenser is to provide the prospective user with a copy of the User Instructional Brochure. Current SEC 801.420(c)(4) requires that technical data useful in selecting, fitting, and checking the performance of a hearing aid be provided in the brochure or in separate labeling that accompanies the device. The 1977 final rule further required that the technical data values provided in the brochure or other labeling be determined according to the test procedures established by the Acoustical Society of America (ASA) in the American National Standard “Specification of Hearing Aid Characteristics,” ANSI S3.22-1976 (ASA 70-1976), which was incorporated by reference in the regulation.
ANSI S3.22 (ASA 70-1976) established measurement methods and specifications for several important hearing aid characteristics. The standard provided a method of ascertaining whether a hearing aid, after being manufactured and shipped, met the specifications and design parameters stated by the manufacturer for a particular model, within the tolerance stated by the standard.
In 1982, ASA revised the standard (ANSI S3.22-1982) (ASA 70-1982). In a final rule published in the Federal Register of July 24, 1985 (50 FR 30153), FDA incorporated the revised standard into SEC 801.420(c)(4). ASA revised the standard again in 1987 (ANSI S3.22-1987) (ASA 70-1987). In a final rule published in the Federal Register of December 21, 1989 (54 FR 52395), FDA incorporated the revised standard into SEC 801.420(c)(4). In 1996, ASA revised the standard again (ANSI S3.22-1996) (ASA 70-1996). In a final rule published in the Federal Register of November 3, 1999 (64 FR 59618), FDA incorporated the revised standard into SEC 801.420(c)(4).
In 2003, ASA revised the standard again (ANSI S3.22-2003). The 1996 version of the standard was written prior to the development of digital hearing aids. Therefore, some of the test procedures described in the 1996 version of the standard, designed for assessment of analogue hearing aids, were modified to accommodate digital technology. The major differences between the two versions of the standard are as follows:
* In the 1996 standard, the gain control was set to a specific reference test position for automatic gain control (AGC) hearing aids and for all other types of hearing aids. In the 2003 standard, AGC hearing aids are tested in AGC mode only for those tests associated with AGC functions and are operated in non-AGC mode for all other tests.
* In the 2003 standard, the tolerance for setting the gain control to reference test setting (RTS) has been widened to +/- 1.5 dB from +/- 1.0 dB.
FDA is now incorporating the 2003 standard into SEC 801.420(c)(4). This will allow hearing aid manufacturers to use the up-to-date methods to determine the technical data values for hearing aids.
II. What Does This Direct Final Rulemaking Do?
In this direct final rule, FDA is:
* Amending SEC 801.420(c)(4) to change the identification of the standard from “American National Standard ‘Specification of Hearing Aid Characteristics,’ ANSI S3.22-1996 (ASA 70-1996) (Revision of ANSI S3.22-1987)” to “American National Standard ‘Specification of Hearing Aid Characteristics,’ ANSI S3.22-2003 (Revision of ANSI S3.22-1996) (Includes April 2007 Erratum)”. FDA also is updating an address in this section, changing “1350 Piccard Dr., rm. 240,” to “1350 Piccard Dr., rm. 150,”.
* Removing SEC 801.420(d). This section requires that manufacturers submit to FDA for review their User Instructional Brochure and other labeling for each type of hearing aid on or before August 15, 1977. This section was included with the initial hearing aid rule in 1977. It was intended to provide for an initial FDA review of the labeling to meet the new requirements. This section is outdated and is no longer necessary.
III. What Are the Procedures for Issuing a Direct Final Rule?
In the Federal Register of November 21, 1997 (62 FR 62466), FDA announced the availability of the guidance document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures” that described when and how FDA will employ direct final rulemaking. We believe that this rule is appropriate for direct final rulemaking because it is intended to make noncontroversial changes to existing regulations. We anticipate no significant adverse comment.
Consistent with FDA’s procedures on direct final rulemaking, elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule that is identical to this direct final rule. The companion proposed rule provides a procedural framework within which the rule may be finalized in the event the direct final rule is withdrawn because of any significant adverse comment. The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. Any comments received in response to the companion proposed rule will also be considered as comments regarding this direct final rule.
If we receive any significant adverse comment, we intend to withdraw this final rule before its effective date by publication of a notice in the Federal Register within 30 days after the comment period ends. A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule’s underlying premise or approach, or would be ineffective or unacceptable without change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. For example, a comment recommending an additional change to the rule will not be considered a significant adverse comment, unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to part of a rule and that part can be severed from the remainder of the rule, we may adopt as final those parts of the rule that are not the subject of a significant adverse comment.
–This is a summary of a Federal Register article originally published on the page number listed below–
Direct final rule.
CFR Part: “21 CFR Part 801″
Citation: “73 FR 31358″
Document Number: “Docket No. FDA-2008-N-0148″
Federal Register Page Number: “31358″
“Rules and Regulations”
Tags: hearing aids, medical devices
Asthma Patients Will Need New Inhalers Soon
Patients who use albuterol inhalers to control asthma take note - the inhaler you are accustomed to will no longer be available at the end of this year. Last week, the Food & Drug Administration (FDA) warned patients not to wait until the last minute to switch to newer alternatives.
The old-style albuterol inhalers used chemicals called chlorofluorocarbons, or CFCs, to propel the drug into the lungs. But CFC-containing consumer products are being phased out because the chemicals damage the Earth’s protective ozone layer. The phaseout of CFC-propelled inhalers is the result of the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under the treaty, the US agreed to phase out production and importation of ozone depleting substances including CFCs.
As of Dec. 31, asthma inhalers with CFCs can no longer be made or sold in the US. Inhalers instead will be powered by ozone-friendly HFAs, or hydrofluoroalkanes. Three HFA-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.
The FDA is urging patients to talk with their health care professionals now about switching to HFA-propelled albuterol inhalers. These products are safe and effective replacements for CFC-propelled albuterol inhalers.
The FDA said that manufacturers have been increasing production of HFA albuterol inhalers, so an adequate supply is available now. According to the agency, HFA-propelled albuterol inhalers may taste and feel different than the CFC-propelled albuterol inhalers. The spray of an HFA-propelled albuterol inhaler may feel softer than that of a CFC-propelled albuterol inhaler. Patients must also prime and clean HFA-propelled albuterol inhalers. Doing so prevents buildup of the drug in the inhalation device, and buildup can block the medicine from reaching the lungs. Each HFA-propelled albuterol inhaler has different priming, cleaning, and drying instructions, and patients should read and understand the instructions first before using the inhaler.