FDA will not issue registration certificates to medical device companies, and will not issue confirmation certificates for products or companies that have been registered or listed. Enterprise registration and product listing information does not mean that FDA approved the company and its products.
Since 2016 spieth medical has its own medical protective products.
FDA registration issues that we generally need to pay attention to are as follows:
Question 1: Which agency issued the FDA certificate? Answer: There is no certificate for FDA registration. If the product is registered with FDA, the registration number will be obtained. FDA will give the applicant a reply (with the signature of the FDA chief executive), but there is no FDA certificate.
FDA issued such a notice at this time is a strong reminder! Due to the recent development of the epidemic in the United States, the demand for medical anti-epidemic products to export to the United States has increased significantly, and the demand for export registration has also increased. However, there are some companies who pretend to be FDA and issue certificates to manufacturers. Some distributors obtain the “FDA” when consulting the manufacturers. “Certificate” may also be counterfeit.
Question 2: Does the FDA need a certified laboratory test? A: The FDA is an enforcement agency, not a service agency. If someone says they are a certification laboratory under the FDA, he is at least misleading consumers, because FDA has neither a service-oriented certification body and laboratory for the public nor a so-called ” laboratory”. As a federal law enforcement agency, the FDA cannot engage in such a matter of being a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue qualified certificates, but will not “**” to the public or recommend a specific company or companies.
Question 3: Does the FDA registration require a US agent?
Answer: Yes, companies must designate an American citizen (company / society) as their agent when registering with the FDA. The agent is responsible for the process services in the United States and is the medium for contacting FDA and the applicant.
Common misunderstandings of FDA registration
1. The FDA registration is different from the CE certification. The certification mode is different from the CE certification product testing + report certificate model. The FDA registration actually uses the integrity declaration model, that is: you meet the relevant standards and ** requirements for your products Responsible, and registered on the US federal website, if the product has an accident, then it must bear the corresponding responsibility. Therefore, for most products, FDA registration does not exist to send samples for testing and issuing certificates.
2. Issue of FDA registration validity period: FDA registration validity period is one year, if more than one year, you need to resubmit the registration, and the annual fee involved also needs to be repaid.
3. Is there a certificate for FDA registration?
In fact, FDA registration does not have a certificate. By registering the product with FDA, the registration number will be obtained. FDA will give the applicant a reply letter (signed by the FDA chief executive), but there is no FDA certificate. The certificate we usually see is issued to the manufacturer by an intermediary agency (registered agent) to prove that it helped the manufacturer complete the “Establishment Registration and Device Listing” required by the US FDA. The mark is to help the manufacturer obtain the FDA registration number.
Post time: Apr-07-2020