2022年10月5日美国FDA官网消息:FDA注册消息FDA注册年金将原来的$5672.00上调到$6493.00,本次调整从2022年10月1号正式实施。如果有出口美国地区的企业,请及时递交FDA认证申请,以免延误出口。
上次上调主要是是针对于医疗器械一类,二类,三类产品。
FDA一类范围目录:
美国FDA认证一类510K豁免清单
PART 880 GENERAL HOSPITAL AND PERSONAL USE DEVICES普通医院和个人使用设备
880.2200Liquid crystal forehead temperature strip液晶前额温度条;
880.2400Bed-patient monitor卧病床病人监视器(只监视病人是否离开床);
880.2700Stand-on patient scale站立式病人体重计;
880.2720 Patient scale非站立式病人体重计;
880.2740 Surgical sponge scale外科手术失血海绵计(不带电)
880.2740Scale, Sponge, Surgical,Electrically-Powered外科手术失血海绵计(带电)
880.2900 Clinical color change thermometer一次性临床色变体温计
880.2920 Clinical mercury thermometer水银体温计
880.2930 Apgar timer阿普加计时器
880.5075 Elastic bandage绷带
880.5090 Liquid bandage液体绷带(液体或粉状,用来覆盖皮肤伤口,或烧伤部位)
880.5100Ac-Powered Adjustable Hospital Bed电动可调病床
880.5110Hydraulic Adjustable Hospital Bed液压可调病床
880.5120Manual Adjustable Hospital Bed手动可调病床
880.5140Pediatric Hospital Bed儿科病床
880.5150 Nonpowered flotation therapy mattress不带电充气式治疗床褥
880.5160 Therapeutic medical binder治疗用固定带(如腹带,裹胸带等)
880.5180 Burn sheet烧伤包裹片;
880.5210 Intravascular catheter securement device针头、导管固定支架;
880.5240 Medical adhesive tape and adhesive bandage医用粘胶带,粘贴绷带
880.5270 Neonatal eye pad新生儿眼罩
880.5300 Medical absorbent fiber医用吸收性纤维
880.5420 Pressure infusor for an I.V. bag输液袋的压力输液器
880.5475 Jet lavage伤口噴射灌洗器
880.5500 AC-powered patient lift交流电病人搬运机
880.5510 Non-AC-powered patient lift.非交流电病人搬运机
880.5550 Alternating pressure air flotationmattress治疗褥疮性溃疡用交变压力充气床褥
880.5560 Temperature regulated water mattress温控水床褥
880.5630 Nipple shield(喂奶用)乳头保护罩
880.5640 Lamb feeding nipple奶嘴
880.5680 Pediatric position holder儿科位置夹(即将小儿固定在一个位置以做治疗或检查的夹具)
880.5780 Medical support stocking医用丝袜(防大腿淤血,静脉曲张的功效)
880.5820 Therapeutic scrotal support阴囊治疗支持(固定)器
880.5950 Umbilical occlusion device新生儿脐带闭塞夹结,胶布等)
880.5960 Lice removal kit除虱子梳(用电池或不用电池;也可带溶液)
880.6025 Absorbent tipped applicator医用涂药刷
880.6050 Ice bag冰袋
880.6060 Medical disposable bedding一次性医用床上用品(床垫,床单,枕头,枕头套等)
880.6070 Bed board医用床板
880.6080 Cardiopulmonary resuscitation board心肺复苏板
880.6085 Hot/cold water bottle医用冷热水瓶(用来传热/冷给病人)
880.6140 Medical chair and table医用桌子,椅子(用来采血,病人身体检查等)
880.6150 Ultrasonic cleaner for medical instruments器械超声清洁器
880.6185 Cast cover防水盖布
880.6190 Mattress cover for medical purposes医用床套(可能带导电,杀菌物
880.6200 Ring cutter戒指切割器(将病人的戒指切下来而不伤到手指)
880.6230 Tongue depressor压舌板
880.6250 Patient examination glove一次性医用检查手套
880.6265 Examination gown病人穿检查用大褂
880.6280 Medical insole医用鞋垫(用来减轻运动员足部因吸收水分而感染的症状)