{"id":56023,"date":"2022-09-12T16:06:57","date_gmt":"2022-09-12T20:06:57","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-issues-final-rule-for-otc-hearing-aids\/"},"modified":"2022-11-10T15:34:42","modified_gmt":"2022-11-10T20:34:42","slug":"fda-issues-final-rule-for-otc-hearing-aids","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/fda-issues-final-rule-for-otc-hearing-aids\/","title":{"rendered":"FDA\u53d1\u5e03\u975e\u5904\u65b9\u836f\u52a9\u542c\u5668\u6700\u7ec8\u89c4\u5219"},"content":{"rendered":"<p>2022\u5e748\u670817\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d1\u5e03\u4e86\u4e00\u9879\u6700\u7ec8\u89c4\u5219\uff0c\u4e3a\u88ab\u8ba4\u4e3a\u6709\u8f7b\u5ea6\u81f3\u4e2d\u5ea6\u542c\u529b\u969c\u788d\u7684\u6d88\u8d39\u8005\u5efa\u7acb\u4e86\u65b0\u7684\u975e\u5904\u65b9\uff08OTC\uff09\u52a9\u542c\u5668\u7c7b\u522b\u3002\u8be5\u89c4\u5219\u4e8e2022\u5e7410\u670817\u65e5\u751f\u6548\uff0c\u5c06\u5141\u8bb8\u6d88\u8d39\u8005\u4ece\u5728\u7ebf\u96f6\u552e\u5546\u548c\u5546\u5e97\u8d2d\u4e70\u52a9\u542c\u5668\uff0c\u800c\u65e0\u9700\u5904\u65b9\u3001\u4f53\u68c0\u6216\u9a8c\u914d\u8c03\u6574\u3002\u8fd9\u4e00\u884c\u52a8\u65e8\u5728\u4e3a\u7f8e\u56fd\u6d88\u8d39\u8005\u63d0\u4f9b\u66f4\u5b9e\u60e0\u3001\u66f4\u6613\u83b7\u5f97\u7684\u52a9\u542c\u5668\u9009\u62e9\u3002<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>\u83b7\u5f97FDA\u5408\u89c4\u65b9\u9762\u7684\u5e2e\u52a9\u3002<\/h3>\n<p>Registrar Corp\u7684\u76d1\u7ba1\u4e13\u5bb6\u5e2e\u52a9\u516c\u53f8\u9075\u5b88FDA\u7684\u8981\u6c42\u3002<\/p>\n<p>\u6709\u5173FDA\u6cd5\u89c4\u8981\u6c42\u7684\u5e2e\u52a9\uff0c\u8bf7\u81f4\u7535:+1-757-224-0177\uff0c\u7535\u5b50\u90ae\u4ef6:<a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a>\uff0c\u6216\u4e0e\u76d1\u7ba1\u987e\u95ee24\u5c0f\u65f6\u804a\u5929:<a href=\"http:\/\/regstaging.wpengine.com\/livechat\">regstaging.wpengine.com\/livechat<\/a>\u3002<\/p>\n<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/zh\/fda-medical-devices\/?lead_source=blog\">\u83b7\u5f97\u5e2e\u52a9<\/a><\/p>\n<\/div>\n<p><strong>\u8bf7\u7ee7\u7eed\u9605\u8bfb\uff0c\u4e86\u89e3<\/strong><strong> OTC \u52a9\u542c\u5668\u5236\u9020\u5546\u7684\u6700\u7ec8\u89c4\u5219\u548c\u5408\u89c4\u622a\u6b62\u65e5\u671f\u7684\u80cc\u666f\u4fe1\u606f\u3002<\/strong><\/p>\n<p>FDA\u4e8e2021\u5e7410\u670820\u65e5\u53d1\u5e03\u4e86\u62df\u8bae\u7684\u89c4\u5219\uff0c\u4ee5\u521b\u5efa\u4e00\u7c7b\u7528\u4e8e\u52a9\u542c\u5668\u7684\u975e\u5904\u65b9\u836f\uff0c\u4ee5\u56de\u5e94\u62dc\u767b\u603b\u7edf2021\u5e747\u6708\u5173\u4e8e\u4fc3\u8fdb\u7f8e\u56fd\u7ecf\u6d4e\u7ade\u4e89\u7684\u884c\u653f\u547d\u4ee4\u3002\u8be5\u547d\u4ee4\u8981\u6c42FDA\u5728120\u5929\u5185\u91c7\u53d6\u884c\u52a8\uff0c\u5141\u8bb8\u5728\u67dc\u53f0\u4e0a\u51fa\u552e\u52a9\u542c\u5668\u3002\u56fd\u4f1a\u57282017\u5e74\u901a\u8fc7\u4e86\u7c7b\u4f3c\u7684\u7acb\u6cd5\uff0c\u8981\u6c42FDA\u521b\u5efa\u4e00\u7c7bOTC\u52a9\u542c\u5668\uff0c\u4f46\u5f53\u65f6\u8be5\u7acb\u6cd5\u5c1a\u672a\u5b8c\u5168\u5b9e\u65bd\u3002<\/p>\n<p>FDA\u9884\u8ba1\u8be5\u89c4\u5219\u5c06\u589e\u52a0\u52a9\u542c\u5668\u5236\u9020\u5546\u4e4b\u95f4\u7684\u521b\u65b0\u548c\u7ade\u4e89\uff0c\u5e76\u964d\u4f4e\u6d88\u8d39\u8005\u7684\u52a9\u542c\u5668\u6210\u672c\u3002FDA\u6253\u7b97\u901a\u8fc7\u5b9e\u65bd\u8be5\u89c4\u5219\u6765\u786e\u4fddOTC\u52a9\u542c\u5668\u7684\u5b89\u5168\u6709\u6548\uff0c\u8be5\u89c4\u5219\u9002\u7528\u4e8e\u201c\u67d0\u4e9b\u9002\u7528\u4e8e18\u5c81\u53ca\u4ee5\u4e0a\u7684\u8f7b\u5ea6\u81f3\u4e2d\u5ea6\u542c\u529b\u969c\u788d\u7684\u4eba\u7684\u7a7a\u6c14\u4f20\u5bfc\u52a9\u542c\u5668\u201d\u3002\u4e0d\u7b26\u5408\u89c4\u5219OTC\u7c7b\u522b\u8981\u6c42\u7684\u52a9\u542c\u5668\uff0c\u4f8b\u5982\u7528\u4e8e\u4e25\u91cd\u542c\u529b\u969c\u788d\u7684\u52a9\u542c\u5668\uff0c\u5c06\u88ab\u5b9a\u4e49\u4e3a\u5904\u65b9\u533b\u7597\u5668\u68b0\u3002<\/p>\n<p>FDA\u4ece\u62df\u8bae\u89c4\u5219\u4e2d\u7eb3\u5165\u4e86\u51e0\u9879\u66f4\u6539\u6765\u6784\u5efa\u6700\u7ec8\u89c4\u5219\uff0c\u5305\u62ec\u964d\u4f4e\u6700\u5927\u58f0\u97f3\u8f93\u51fa\u4ee5\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u56e0\u97f3\u91cf\u8fc7\u5927\u800c\u9020\u6210\u7684\u542c\u529b\u635f\u5931\uff0c\u4fee\u6539\u52a9\u542c\u5668\u5728\u8033\u9053\u4e2d\u7684\u6df1\u5ea6\u63d2\u5165\u65b9\u5f0f\uff0c\u8981\u6c42\u6240\u6709OTC\u52a9\u542c\u5668\u90fd\u5305\u542b\u7528\u6237\u53ef\u4ee5\u8c03\u6574\u7684\u97f3\u91cf\u63a7\u5236\uff0c\u5e76\u7b80\u5316\u6807\u7b7e\u63aa\u8f9e\u4ee5\u65b9\u4fbf\u6d88\u8d39\u8005\u7406\u89e3\u3002<\/p>\n<p>\u6b64\u5916\uff0cOTC\u52a9\u542c\u5668\u6700\u7ec8\u89c4\u5219\u8fd8\u5b9e\u73b0\u4e86\u4ee5\u4e0b\u76ee\u6807\uff1a<\/p>\n<ul>\n<li>\u901a\u8fc7\u4fee\u6539\u5904\u65b9\u52a9\u542c\u5668\u7684\u73b0\u6709\u89c4\u5219\uff0c\u4f7f\u6cd5\u89c4\u4e0e\u65b0\u7684OTC\u7c7b\u522b\u4fdd\u6301\u4e00\u81f4<\/li>\n<li>\u5e9f\u9664\u52a9\u542c\u5668\u7684\u9500\u552e\u6761\u4ef6<\/li>\n<li>\u89e3\u51b3\u8054\u90a6OTC\u52a9\u542c\u5668\u6cd5\u89c4\u5bf9\u5dde\u7ea7\u52a9\u542c\u5668\u6cd5\u89c4\u7684\u67d0\u4e9b\u5f71\u54cd\u7684\u6761\u6b3e\u3002<\/li>\n<li>\u4e3aOTC\u548c\u5904\u65b9\u52a9\u542c\u5668\u63d0\u4f9b\u65b0\u7684\u6807\u7b7e\u8981\u6c42\u3002<\/li>\n<li>\u5305\u62ec\u7279\u5b9a\u4e8e OTC \u52a9\u542c\u5668\u7684\u6027\u80fd\u89c4\u683c\u548c\u8bbe\u5907\u8bbe\u8ba1\u8981\u6c42<\/li>\n<li>\u4f7fOTC\u52a9\u542c\u5668\u7b26\u5408\u8981\u6c42<\/li>\n<\/ul>\n<p>\u5728\u6700\u7ec8\u89c4\u5219\u751f\u6548\u65e5\u671f\u4e4b\u524d\u51fa\u552e\u7684\u52a9\u542c\u5668\uff0c\u5305\u62ec\u5177\u6709510\uff08k\uff09\u8bb8\u53ef\u7684\u52a9\u542c\u5668\uff0c\u5fc5\u987b\u5728\u6700\u7ec8\u89c4\u5219\u751f\u6548\u65e5\u671f\u540e\u7684180\u5929\u5185\u7b26\u5408\u65b0\u7684\u6216\u4fee\u8ba2\u7684\u8981\u6c42\u3002<\/p>\n<p>\u5728\u751f\u6548\u65e5\u671f\u4e4b\u524d\uff0c\u5c1a\u672a\u53d1\u552e\u6216\u5df2\u53d1\u552e\u4f46\u7531\u4e8e\u4e0e\u6b64\u89c4\u5219\u65e0\u5173\u7684\u53d8\u66f4\u800c\u9700\u8981\u63d0\u4ea4\u65b0\u7684510\uff08k\uff09\u7684\u52a9\u542c\u5668\uff08\u00a7 807.81\uff08a\uff09\uff083\uff09\uff09\uff0c\u5728\u6700\u7ec8\u89c4\u5219\u751f\u6548\u65e5\u671f\u6216\u4e4b\u540e\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u4e4b\u524d\uff0c\u5fc5\u987b\u9075\u5b88\u65b0\u7684\u6216\u4fee\u8ba2\u540e\u7684\u8981\u6c42\uff0c\u5176\u4e2d\u5305\u62ec\u83b7\u5f97510\uff08k\uff09\u8bb8\u53ef\uff08\u5982\u679c\u9002\u7528\uff09\u3002<\/p>\n<p>\u5f53\u52a9\u542c\u5668\u51fa\u73b0\u4ee5\u4e0b\u60c5\u51b5\u65f6\uff0cFDA\u4e0d\u6253\u7b97\u6267\u884c\u63d0\u4ea4510\uff08k\uff09\u5e76\u83b7\u5f97510\uff08k\uff09\u8bb8\u53ef\u7684\u8981\u6c42\uff1a<\/p>\n<ul>\n<li>\u5728\u6700\u7ec8\u89c4\u5219\u751f\u6548\u65e5\u671f\u4e4b\u524d\u5408\u6cd5\u51fa\u552e<\/li>\n<li>\u5728\u5408\u89c4\u65e5\u671f\u5f53\u5929\u6216\u4e4b\u524d\u8fdb\u884c\u4e86\u66f4\u6539\uff0c\u9700\u8981\u65b0\u7684510\uff08k\uff09\uff0c\u800c\u8fd9\u4e9b\u66f4\u6539\u4ec5\u7528\u4e8e\u6ee1\u8db3OTC\u52a9\u542c\u5668\u63a7\u5236<\/li>\n<li>\u5df2\u53d1\u751f\u4e0d\u4f1a\u5bf9\u8bbe\u5907\u5b89\u5168\u6027\u6216\u6709\u6548\u6027\u4ea7\u751f\u4e0d\u5229\u5f71\u54cd\u7684\u66f4\u6539<\/li>\n<li>\u4ee5\u5176\u4ed6\u65b9\u5f0f\u7b26\u5408\u9002\u7528\u8981\u6c42<\/li>\n<li>\u5728\u5236\u9020\u5546\u8fdb\u884c\u66f4\u6539\u7684\u5408\u89c4\u65e5\u671f\u6216\u4e4b\u524d\u6709\u6587\u6863\uff0c\u5e76\u786e\u5b9a\u66f4\u6539\u4e0d\u4f1a\u5bf9\u8bbe\u5907\u5b89\u5168\u6027\u6216\u6709\u6548\u6027\u4ea7\u751f\u4e0d\u5229\u5f71\u54cd<\/li>\n<\/ul>\n<p>OTC \u52a9\u542c\u5668\u7684\u63d0\u51fa\uff0c\u662f\u4ece\u533b\u7597\u7ea7\u52a9\u542c\u5668\u884c\u4e1a\u91cc\u9762\u53d1\u8d77\u7684\u3002\u800c\u8f85\u542c\u8033\u673a\u7684\u6982\u5ff5\uff0c\u5219\u66f4\u591a\u7684\u662f\u4ece\u6d88\u8d39\u7ea7\u542c\u529b\u4ea7\u54c1\u884c\u4e1a\u63d0\u51fa\u7684\u3002<\/p>\n<p>\u8f85\u542c\u8033\u673a\uff08Hearable Devices, \u6216\u8005Hearing Buds\uff09\uff0c\u7b80\u5355\u7684\u8bf4\uff0c\u662f\u4e00\u79cd\u589e\u5f3a\u578b\u8033\u673a\uff0c\u9002\u7528\u4e8e\u8f7b\u5ea6\u542c\u635f\u53ca\u90e8\u5206\u4e2d\u5ea6\u542c\u635f\u4eba\u7fa4\u3002\u5176\u53ef\u4ee5\u5b9e\u73b0\u4e00\u4e9b\u52a9\u542c\u5668\u7684\u529f\u80fd\uff0c\u5982\uff1a\u58f0\u97f3\u7684\u5206\u6bb5\u538b\u7f29\u8865\u507f\u3002\u4e3b\u8981\u9762\u5411\u56e0\u4e3a\u957f\u671f\u4f69\u6234\u8033\u673a\uff0c\u5927\u97f3\u91cf\u542c\u6b4c\u800c\u9020\u6210\u8f7b\u5ea6\u542c\u635f\u4eba\u7fa4\uff0c\u6216\u56e0\u4e3a\u5e74\u9f84\u7684\u589e\u957f\u9010\u6e10\u542c\u529b\u4e0b\u964d\u7684\u4eba\u7fa4\u3002<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>\u83b7\u5f97FDA\u5408\u89c4\u65b9\u9762\u7684\u5e2e\u52a9\u3002<\/h3>\n<p>Registrar Corp\u7684\u76d1\u7ba1\u4e13\u5bb6\u5e2e\u52a9\u516c\u53f8\u9075\u5b88FDA\u7684\u8981\u6c42\u3002<\/p>\n<p>\u6709\u5173FDA\u6cd5\u89c4\u8981\u6c42\u7684\u5e2e\u52a9\uff0c\u8bf7\u81f4\u7535:+1-757-224-0177\uff0c\u7535\u5b50\u90ae\u4ef6:<a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a>\uff0c\u6216\u4e0e\u76d1\u7ba1\u987e\u95ee24\u5c0f\u65f6\u804a\u5929:<a href=\"http:\/\/regstaging.wpengine.com\/livechat\">regstaging.wpengine.com\/livechat<\/a>\u3002<\/p>\n<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/zh\/fda-medical-devices\/?lead_source=blog\">\u83b7\u5f97\u5e2e\u52a9<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>2022\u5e748\u670817\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d1\u5e03\u4e86\u4e00\u9879\u6700\u7ec8\u89c4\u5219\uff0c\u4e3a\u88ab\u8ba4\u4e3a\u6709\u8f7b\u5ea6\u81f3\u4e2d\u5ea6\u542c\u529b\u969c\u788d\u7684\u6d88\u8d39\u8005\u5efa\u7acb\u4e86\u65b0\u7684\u975e\u5904\u65b9\uff08OTC\uff09\u52a9\u542c\u5668\u7c7b\u522b\u3002\u8be5\u89c4\u5219\u4e8e2022\u5e7410\u670817\u65e5\u751f\u6548\uff0c\u5c06\u5141\u8bb8\u6d88\u8d39\u8005\u4ece\u5728\u7ebf\u96f6\u552e\u5546\u548c\u5546\u5e97\u8d2d\u4e70\u52a9\u542c\u5668\uff0c\u800c\u65e0\u9700\u5904\u65b9\u3001\u4f53\u68c0\u6216\u9a8c\u914d\u8c03\u6574\u3002\u8fd9\u4e00\u884c\u52a8\u65e8\u5728\u4e3a\u7f8e\u56fd\u6d88\u8d39\u8005\u63d0\u4f9b\u66f4\u5b9e\u60e0\u3001\u66f4\u6613\u83b7\u5f97\u7684\u52a9\u542c\u5668\u9009\u62e9\u3002 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