The US Food and Drug Administration (Food and DrugAdministration) referred to the FDA , the FDA is the US government in the Health and Human Services (DHHS) and the Ministry of Public Health (PHS) , one of the implementing agencies set up. As a scientific regulatory agency, the FDA 's role is to ensure the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products produced or imported in the United States. It was one of the first federal agencies to focus on consumer protection.
The FDA 's management of medical devices is carried out through the Center for Devices and Radiological Health ( CDRH ), which supervises the production, packaging and distribution of medical devices and conducts business activities in compliance with laws.
Medical devices range from medical gloves to cardiac pacemakers under the supervision of the FDA . According to medical uses and possible harm to the human body, the FDA classifies medical devices into categories Ⅰ, Ⅱ, and Ⅲ. The more category supervision. If the product is a novel invention that did not exist on the market, the FDA requires manufacturers to perform rigorous human experiments and have convincing medical and statistical evidence that the product is effective and safe.
FDA certification of medical devices , including: manufacturers' FDA registration, product FDA registration, product market registration ( Form 510 registration), product market review approval ( PMA audit), medical device labeling and technical transformation, customs clearance, registration, pre-market For the report, the following materials must be submitted: ( 1 ) five finished products in a complete package, ( 2 ) device structure drawing and written description, ( 3 ) device performance and working principle; ( 4 ) device safety demonstration or test materials ( 5 ) Introduction to manufacturing process, ( 6 ) Summary of clinical trials, ( 7 ) Product specifications . If the device has radioactive energy or releases radioactive material, it must be described in detail.
FDA certification process
1. preparation stage
A copy of the corporate legal person license;
Copy of production (health) license, certificate of conformity;
Company profile (established time, technical strength, main products, extreme performance, asset status).
2. Acceptance of Technology Preliminary Examination Declaration
Submit English translations of DMF (drug master file) and SOP (standard operating procedures) to agents;
Based on the comments of the agent, the above documents were amended.
3. DMF data review
FDA carefully reviewed and went to the factory to inspect the site to check whether the DMF document was true;
If the FDA does not find a major error and believes it meets the requirements, it proposes a pre-approval inspection plan.
4. FDA inspection
Question 1: Which agency issued the FDA certificate?
A: There is no certificate for FDA registration. Products registered with the FDA will obtain a registration number. The FDA will send a reply to the applicant (with the signature of the FDA Chief Executive), but there is no FDA certificate.
Question 2: Does the FDA need a designated accredited laboratory test ?
Answer: The FDA is an enforcement agency, not a service agency. If someone says that they are FDA- accredited laboratories, then he is at least misleading consumers, because the FDA has neither a service-oriented certification body or laboratory for the public, nor a so-called "designated laboratory". The FDA, as a federal law enforcement agency, cannot engage in such a role as a referee and an athlete. The FDA will only recognize the GMP quality of service testing laboratories and issue certificates of conformity, but will not "designate" or recommend a specific one or several to the public.
Question 3: Does FDA registration necessarily require a U.S. agent?
A: Yes, Chinese applicants must appoint an American citizen (company / community) as their agent when registering with the FDA . This agent is responsible for the process services located in the United States and is the medium for contacting the FDA with the applicant.