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The difference between FDA certification, FDA testing and FDA registration

The difference between FDA certification, FDA testing and FDA registration

Brand Name: LCS
Model Number: Optional
MOQ: 1 pcs
Price: 5000 USD
Packaging Details: Electronic version
Payment Terms: L/C, D/A, T/T, Western Union, MoneyGram
Detail Information
Place of Origin:
CN
Certification:
FDA certification
CMA:
Laboratory Qualification Accreditation, Also Known As Metrology Certification
NVLAP:
I.e. National Laboratory Voluntary Accreditation Program
A2LA Authorized Laboratory:
Can Complete Self-issuance Of FCC SDoC And FCC ID Certification Test Reports
CEC:
California Energy Commission
CBTL:
CB Testing Laboratory
Supply Ability:
2000 pcs per year
Product Description

Certification Introduction:

 

FDA (Food and Drug Administration) certification is a certificate of conformity for food or drugs issued by the Food and Drug Administration of the US government. Due to its scientific nature and rigor, this certification has become a world-recognized standard. Drugs certified by the FDA can be sold not only in the United States, but also in most countries and regions in the world. FDA is the abbreviation of the U.S. Food and Drug Administration. It is an authoritative international medical review agency. It is authorized by the U.S. Congress, the federal government, and is the highest law enforcement agency specializing in food and drug administration.

The difference between FDA certification, FDA testing and FDA registration 0

The FDA is a government health regulatory regulatory agency composed of doctors, lawyers, microbiologists, pharmacologists, chemists, statisticians and other professionals dedicated to protecting, promoting and improving national health. Food, drugs, cosmetics and medical devices certified by the FDA are safe and effective for the human body. In nearly 100 countries including the United States, only materials, devices and technologies approved by the FDA can be commercialized for clinical application.

 

1. FDA testing of food materials


"Food Contact Materials" (abbreviation: FCM) refers to materials that come into contact with food during normal use of products. Because they are in direct contact with food, they are called the "underwear" of food, and their safety directly affects Food safety is also the most critical control point for enterprises. Products involved in food contact materials include food packaging, tableware, kitchen utensils, food processing machinery and kitchen appliances, etc. Food contact materials include:

Plastic, resin, rubber, silicone, metal, alloy, electroplating, paper, cardboard, glass, ceramics, enamel, colorant, printing coating, ink, etc.


Food contact materials and products may affect the smell, taste and color of food during the process of contact with food, and may also release a certain amount of toxic chemical components such as heavy metals and toxic additives. These chemical components will migrate into food and Ingested by the human body, endangering human health.


2. Food FDA testing
3. Medical device FDA testing
4. Cosmetics FDA testing
5. FDA testing of drugs and biological products


Note: LCS business scope is: FDA testing of food materials + FDA testing of laser instruments

 

application process
1. Consultation---The applicant provides product information pictures or describes the products and materials required to apply for FDA.
2. Quotation --- Based on the information provided by the applicant, the technical engineer will make an evaluation, determine the items that need to be tested, and provide a quotation to the applicant.
3. After confirming the quotation, the applicant fills in the test application form and test samples.
4. Sample testing - testing will be conducted in accordance with applicable FDA standards
5. Provide FDA certification report after the test is completed

 

About FDA certificate
FDA registration actually adopts the integrity declaration model, that is: you are responsible for your products meeting relevant standards and safety requirements, and register on the US federal website.

Does FDA registration have a certificate? In fact, all actions of FDA registration are registered online, and there is no such thing as a certificate. So what is the FDA certificate circulating on the market? In fact, it is a declarative document issued by the agency itself, proving that the product has been registered with the FDA.

 

The difference between FDA certification, FDA testing and FDA registration

 

It can be understood that FDA testing generally targets these types of products: 1. Class II and III medical devices; 2. Cosmetics and daily necessities; 3. Food contact materials;

FDA registration is generally divided into: 1. Cosmetics 2. LED and laser products 3. Medical devices 4. Food 5. Drugs

FDA certification is the collective name for FDA testing and FDA registration. Both of these can be called FDA certification. FDA certification is just a colloquial term.

 

·Which agency issues the FDA certificate?

 

FDA registration does not have a certificate. The product will obtain a registration number by registering with the FDA. The FDA will give the applicant a reply letter (with the signature of the FDA chief executive), but there is no such thing as an FDA certificate.


· Does FDA require designated certified laboratories for testing?

FDA is an enforcement agency, not a service agency. If someone says that they are a certification laboratory affiliated with the FDA, then he is at least misleading consumers, because the FDA has neither public-facing service certification agencies and laboratories nor a so-called "designated laboratory." As a federal law enforcement agency, the FDA cannot engage in such matters as both a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue certificates of conformity to qualified ones, but it will not "designate" or recommend a specific laboratory or laboratories to the public.


· Does FDA registration require a US agent?

Yes, Chinese applicants must appoint a U.S. citizen (company/society) as their agent when registering with the FDA. The agent is responsible for performing process services in the United States and is the intermediary between FDA and the applicant.

COMMONPROBLEMSANDPRECAUTIONSOFBQBCOMMONPROBLEMSANDPRECAUTIONSOFBQBCOMMONPROBLEMSANDPRECAUTIONSOFBQBCOMMONPROBLEMSANDPRECAUTIONSOFBQBCOMMONPROBLEMSANDPRECAUTIONSOFBQB

 

 

The difference between FDA certification, FDA testing and FDA registration 1
 
项目 Item UL cTUVus ETL
发证资格 Certification qualifications 美国NRTL(国家认可实验室)和加拿大标准局SCC
US NRTL (Nationally Recognized Laboratory) and Canadian Standards Bureau SCC
认可机构 Accreditation body
认证市场 Certification market 北美(美国及加拿大) North America (United States and Canada)
颁证及测试机构 UL美华试验室检测并出具结案信 LCS测试 LCS test LCS测试 LCS test
Certification and testing agencies UL Meihua Laboratory tests and issues a closing letter TUV发证 TUV certification ITS发证 ITS certification
申请时间 Lead time 5-12weeks 3-4weeks 3-4weeks
参考 Reference
申请费用 Application fee 相比三者比较贵 More expensive than the three 费用比较优惠 The cost is relatively favorable 费用比较优惠 The cost is relatively favorable
优势 Advantage 美国本土机构,认可度最高 美加地区老牌认证机构 国际认证机构,权威而不昂贵 美国本土机构,认可度高
Native American institutions with high recognition
A local institution in the United States with the highest degree of recognition. International certification body, authoritative and not expensive
A long-established certification agency in the United States and Canada. 同样得到美国NRTL的认可
Also recognized by the US NRTL
劣势 Disadvantages 因为是老牌机构,测试,厂检及档案费最高,周期较长. 北美市场品牌知名度 稍低于UL 北美市场品牌知名度 稍低于UL
Because it is an old institution, testing, factory inspection and filing fees are the highest and the cycle is longer. Brand awareness in the North American market is slightly lower than UL Brand awareness in the North American market is slightly lower than UL
 
 

Products Details

Home > Products >
Certification
>
The difference between FDA certification, FDA testing and FDA registration

The difference between FDA certification, FDA testing and FDA registration

Brand Name: LCS
Model Number: Optional
MOQ: 1 pcs
Price: 5000 USD
Packaging Details: Electronic version
Payment Terms: L/C, D/A, T/T, Western Union, MoneyGram
Detail Information
Place of Origin:
CN
Brand Name:
LCS
Certification:
FDA certification
Model Number:
Optional
CMA:
Laboratory Qualification Accreditation, Also Known As Metrology Certification
NVLAP:
I.e. National Laboratory Voluntary Accreditation Program
A2LA Authorized Laboratory:
Can Complete Self-issuance Of FCC SDoC And FCC ID Certification Test Reports
CEC:
California Energy Commission
CBTL:
CB Testing Laboratory
Minimum Order Quantity:
1 pcs
Price:
5000 USD
Packaging Details:
Electronic version
Delivery Time:
5-10 work days
Payment Terms:
L/C, D/A, T/T, Western Union, MoneyGram
Supply Ability:
2000 pcs per year
Product Description

Certification Introduction:

 

FDA (Food and Drug Administration) certification is a certificate of conformity for food or drugs issued by the Food and Drug Administration of the US government. Due to its scientific nature and rigor, this certification has become a world-recognized standard. Drugs certified by the FDA can be sold not only in the United States, but also in most countries and regions in the world. FDA is the abbreviation of the U.S. Food and Drug Administration. It is an authoritative international medical review agency. It is authorized by the U.S. Congress, the federal government, and is the highest law enforcement agency specializing in food and drug administration.

The difference between FDA certification, FDA testing and FDA registration 0

The FDA is a government health regulatory regulatory agency composed of doctors, lawyers, microbiologists, pharmacologists, chemists, statisticians and other professionals dedicated to protecting, promoting and improving national health. Food, drugs, cosmetics and medical devices certified by the FDA are safe and effective for the human body. In nearly 100 countries including the United States, only materials, devices and technologies approved by the FDA can be commercialized for clinical application.

 

1. FDA testing of food materials


"Food Contact Materials" (abbreviation: FCM) refers to materials that come into contact with food during normal use of products. Because they are in direct contact with food, they are called the "underwear" of food, and their safety directly affects Food safety is also the most critical control point for enterprises. Products involved in food contact materials include food packaging, tableware, kitchen utensils, food processing machinery and kitchen appliances, etc. Food contact materials include:

Plastic, resin, rubber, silicone, metal, alloy, electroplating, paper, cardboard, glass, ceramics, enamel, colorant, printing coating, ink, etc.


Food contact materials and products may affect the smell, taste and color of food during the process of contact with food, and may also release a certain amount of toxic chemical components such as heavy metals and toxic additives. These chemical components will migrate into food and Ingested by the human body, endangering human health.


2. Food FDA testing
3. Medical device FDA testing
4. Cosmetics FDA testing
5. FDA testing of drugs and biological products


Note: LCS business scope is: FDA testing of food materials + FDA testing of laser instruments

 

application process
1. Consultation---The applicant provides product information pictures or describes the products and materials required to apply for FDA.
2. Quotation --- Based on the information provided by the applicant, the technical engineer will make an evaluation, determine the items that need to be tested, and provide a quotation to the applicant.
3. After confirming the quotation, the applicant fills in the test application form and test samples.
4. Sample testing - testing will be conducted in accordance with applicable FDA standards
5. Provide FDA certification report after the test is completed

 

About FDA certificate
FDA registration actually adopts the integrity declaration model, that is: you are responsible for your products meeting relevant standards and safety requirements, and register on the US federal website.

Does FDA registration have a certificate? In fact, all actions of FDA registration are registered online, and there is no such thing as a certificate. So what is the FDA certificate circulating on the market? In fact, it is a declarative document issued by the agency itself, proving that the product has been registered with the FDA.

 

The difference between FDA certification, FDA testing and FDA registration

 

It can be understood that FDA testing generally targets these types of products: 1. Class II and III medical devices; 2. Cosmetics and daily necessities; 3. Food contact materials;

FDA registration is generally divided into: 1. Cosmetics 2. LED and laser products 3. Medical devices 4. Food 5. Drugs

FDA certification is the collective name for FDA testing and FDA registration. Both of these can be called FDA certification. FDA certification is just a colloquial term.

 

·Which agency issues the FDA certificate?

 

FDA registration does not have a certificate. The product will obtain a registration number by registering with the FDA. The FDA will give the applicant a reply letter (with the signature of the FDA chief executive), but there is no such thing as an FDA certificate.


· Does FDA require designated certified laboratories for testing?

FDA is an enforcement agency, not a service agency. If someone says that they are a certification laboratory affiliated with the FDA, then he is at least misleading consumers, because the FDA has neither public-facing service certification agencies and laboratories nor a so-called "designated laboratory." As a federal law enforcement agency, the FDA cannot engage in such matters as both a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue certificates of conformity to qualified ones, but it will not "designate" or recommend a specific laboratory or laboratories to the public.


· Does FDA registration require a US agent?

Yes, Chinese applicants must appoint a U.S. citizen (company/society) as their agent when registering with the FDA. The agent is responsible for performing process services in the United States and is the intermediary between FDA and the applicant.

COMMONPROBLEMSANDPRECAUTIONSOFBQBCOMMONPROBLEMSANDPRECAUTIONSOFBQBCOMMONPROBLEMSANDPRECAUTIONSOFBQBCOMMONPROBLEMSANDPRECAUTIONSOFBQBCOMMONPROBLEMSANDPRECAUTIONSOFBQB

 

 

The difference between FDA certification, FDA testing and FDA registration 1
 
项目 Item UL cTUVus ETL
发证资格 Certification qualifications 美国NRTL(国家认可实验室)和加拿大标准局SCC
US NRTL (Nationally Recognized Laboratory) and Canadian Standards Bureau SCC
认可机构 Accreditation body
认证市场 Certification market 北美(美国及加拿大) North America (United States and Canada)
颁证及测试机构 UL美华试验室检测并出具结案信 LCS测试 LCS test LCS测试 LCS test
Certification and testing agencies UL Meihua Laboratory tests and issues a closing letter TUV发证 TUV certification ITS发证 ITS certification
申请时间 Lead time 5-12weeks 3-4weeks 3-4weeks
参考 Reference
申请费用 Application fee 相比三者比较贵 More expensive than the three 费用比较优惠 The cost is relatively favorable 费用比较优惠 The cost is relatively favorable
优势 Advantage 美国本土机构,认可度最高 美加地区老牌认证机构 国际认证机构,权威而不昂贵 美国本土机构,认可度高
Native American institutions with high recognition
A local institution in the United States with the highest degree of recognition. International certification body, authoritative and not expensive
A long-established certification agency in the United States and Canada. 同样得到美国NRTL的认可
Also recognized by the US NRTL
劣势 Disadvantages 因为是老牌机构,测试,厂检及档案费最高,周期较长. 北美市场品牌知名度 稍低于UL 北美市场品牌知名度 稍低于UL
Because it is an old institution, testing, factory inspection and filing fees are the highest and the cycle is longer. Brand awareness in the North American market is slightly lower than UL Brand awareness in the North American market is slightly lower than UL