Medical Device FDA Registration 510(k) Review
|FDA is the acronym of "Food and Drug Administration" of the USA. Products sold to the US market should own FDA registration. They are food, drug, medicine, cosmetics, medical devices, tobacco and so on.
Center for Devices and Radiological Health (CDRH) in FDA is responsible for medical device registration. The center supervises the producers, packagers, and distributors to operate business and obey laws.
Medical devices have wide range, small to medical gloves, big to cardiac pacemaker. They are all under the supervision of FDA. According to the potential damage to human body, FDA divides the medical devices into Class I, II and III. Higher class is supervised more.
If the device is novel invention without equivalence in the market, FDA requires the manufacturer to perform human trial, and submit the convinced medical and statistic evidence to prove the effect and safety of the product.
For Class I medical devices, such as spectacle glasses, only Annual fee is required, and then apply for registration;
For Class II medical devices, such as dental unit, surgical gloves and so on, before registration, 510(k) Premarket Notification is requied.
For Class III medical devices, such as pulse generator, should be PMA certified before registration.
Shanghai CV Certification Technology Co., Ltd. provides FDA Registration services, include:
- 510(k) compiling and review;
- DUNS number application;
- FDA Annual fee PIN number application;
- PMA inspection;
- US Agent service;
- FDA registration to obtain Operator number, Registration number and Listing number.
Shanghai CV Certification Technology Co., Ltd. professionally provides Spectacle glasses FDA Registration, Surgical mask FDA Registration, Therapeutic massager FDA Registration, Hearing-aid FDA Registration, Ultrasonic scanner FDA Registration, Electrocardiograph FDA Registration, Cosmetic instrument FDA Registration, Electric thermometer FDA Registration, Dental chair FDA Registration, Oral cavity evacuator FDA Registration, Saliva ejector FDA Registration, Ultrasonic scaler FDA Registration, Dental hand instrument FDA Registration, Preformed gold denture tooth FDA Registration, Cutaneous electrode FDA Registration, Acupuncture needle FDA Registration, Incubator FDA Registration, Bandage FDA Registration, Wound dressing FDA Registration, Dialysate concentrate FDA Registration, Surgical dress FDA Registration, Examination Gown FDA Registration, Isolation Gown FDA Registration, Surgical Suit FDA Registration, Tourniquet FDA Registration, Air compressor FDA Registration, Electric wheel chair FDA Registration, DUNS number application, 510(k) document compiling and reviewing, and so on.