美國技術性法規通知文件(TBT通知文件)

發出會員國: 美國USA
文件編號: G/TBT/N/USA/1791
標題: Committee on Technical Barriers to Trade - Notification - United States - Hearing aids
文件通知日期: 2021/10/21
評論截止日期: 2022/01/18
產品內容: 【中文】

美國 通知-助聽器

【原文】

Hearing aids; Hearing aids (excl. parts and accessories) (HS 902140); Quality (ICS 03.120), Aids for deaf and hearing impaired people (ICS 11.180.15)

產品內容說明: 【中文】

建議的規則-美國食品和藥物管理局(FDA)建議為非處方藥(OTC)助聽器設立一個監管類別,並進行相關修訂,以更新助聽器的監管架構。具體來說,我們建議定義OTC助聽器並制定適用的要求;修訂現有規則以與新的OTC類別保持一致;廢除適用於助聽器的銷售條件;修訂現有的助聽器標籤要求;並更新與聯邦豁免申請有關的決定的法規,這些法規將因助聽器要求的改變而變得過時。這項行動,如果最終確定,將更清楚地定義處方助聽器;但是,它不會改變現有設備類型的分類。透過創建OTC助聽器的監管類別和修訂現有規則,我們打算為這些設備的安全和有效性提供合理的保證,並促進助聽器技術的獲取和創新,從而保護和促進公眾健康。

【原文】

Proposed rule - The Food and Drug Administration (FDA, we, or the Agency) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. Specifically, we propose to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements. This action, if finalized, would more clearly define prescription hearing aids; however, it would not change the classification of existing device types. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.

G/TBT/N/USA/1791 的所有原始文件:
序號文件編號文件標題通知日期下載文件(另開視窗)
1 G/TBT/N/USA/1791 Committee on Technical Barriers to Trade - Notification - United States - Hearing aids 2021/10/21下載文件