FDA certification

The US Food and Drug Administration (FDA) will ban most powdered medical gloves, and the deadline for review of this proposal is June 20, 2016

On September 2, 2016, the US Food and Drug Administration (FDA) issued the final rule on the safety and efficacy of antibacterial soap

Please pay attention to the exit! LED lights will be included in the FDA regulatory scope

The Food and Drug Administration (FDA) in the United States, abbreviated as FDA, The FDA is one of the executive agencies established by the US government within the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS).

As a scientific regulatory agency, the FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biologics, medical devices, and radiation products produced or imported domestically in the United States. It is one of the earliest federal agencies with consumer protection as its primary function. This institution is closely related to the lives of every American citizen. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries promote and monitor the safety of their domestic products by seeking and receiving assistance from the FDA.

The food and Drug Administration (FDA) oversees the supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with an alcohol content of less than 7%, and electronic products; Testing, inspection, and certification of the impact of ionizing and non-ionic radiation generated during the use or consumption of products on human health and safety. According to regulations, the above-mentioned products must undergo FDA inspection to prove their safety before they can be sold in the market. The FDA has the authority to inspect manufacturers and to prosecute violators.

Introduction to Medical Device Certification

There is a clear and strict definition for medical devices, which is as follows: Medical devices refer to instruments, devices, tools, machinery, instruments, insertion tubes, in vitro reagents, and other related items that meet the following conditions, including components, parts, or accessories: those explicitly listed in the appendix or both of the above; Intended for use in the diagnosis of animal or human diseases, or other physical conditions, or for the cure, alleviation, and treatment of diseases; Expected to affect the bodily functions or structures of animals or humans, but not through metabolism to achieve its primary purpose. Only products that meet the above definition are considered medical devices. Under this definition, not only various instruments and tools in hospitals, but also fitness equipment such as eyeglass frames, eyeglass lenses, toothbrushes, and massagers that consumers can purchase in general stores are within the scope of FDA management. It is slightly different from the recognition of medical devices in China. According to different risk levels, medical devices are classified into three categories: Class I, II, III, and Class III has the highest risk level. The FDA specifies the product classification and management requirements for each medical device, and currently has over 1700 medical device product catalogs. Any medical device that wants to enter the US market must first clarify the product classification and management requirements for application for listing. Many laws have been formulated for medical devices, and modifications and supplements have been made from time to time, but there are not many fundamental laws, mainly including the Federal Food, Drug, and Cosmetic Act (FDC Act); Public Health Services Act; Fair Packaging and Labeling Act; Health and Safety Radiation Control Act; Safe Medical Devices Act; Modernization Act. Regarding these bills, The FDA has provided a very detailed explanation, accompanied by specific operational requirements. Before planning to enter the US market, companies need to carefully evaluate the regulations and specific requirements related to their products (including different US product standard requirements). After clarifying the above information, the enterprise can start preparing the relevant application materials and follow certain procedures to apply to the FDA for approval and recognition. For any product, companies need to register and list their products. For Class I products (accounting for about 47%), general control is implemented, and the vast majority of products only need to be registered, listed, and comply with GMP standards to enter the US market (a very small number of products are even exempt from GMP, and a very small number of retained products need to submit a 510K application or PMN (Premarket Notification) to the FDA); For Class II products (accounting for about 46%), special control is implemented. After registration and listing, enterprises also need to implement GMP and submit a 510 (K) application (very few products are exempt from 510 (K)); For Class III products (accounting for about 7%), pre-market approval is implemented. After registration and listing, enterprises must implement GMP and submit PMA Premarket Application to FDA (some Class III products are still PMN). For Class I products, after submitting relevant documents to the FDA, The FDA only makes announcements and does not issue relevant documents to companies; For Class II and III medical devices, companies must submit a PMN or PMA, At the same time as the announcement, the FDA will issue a formal market access clearance letter to companies, allowing them to directly sell their products in the US medical device market under their own name. As for whether to conduct on-site GMP assessment at the enterprise during the application process, it is determined by the FDA based on comprehensive factors such as product risk level, management requirements, and market feedback. Based on the above content, it can be concluded that the vast majority of products can obtain FDA approval for marketing after undergoing enterprise registration, product listing, and implementing GMP, or submitting a 510 (K) application.

Food certification and testing (food, agricultural products, seafood)

The FDA's regulatory agency for food, agricultural products and seafood is the Center for Food Safety and Nutrition (CFASAN), whose responsibility is to ensure that American food supplies are safe, clean, fresh and clearly labeled. The food supervised by the center imports $240 billion annually, of which $15 billion belongs to imported food, which is the main monitoring focus of the center. The scope of products involved includes the following foreign food production and processing enterprises that must register with the FDA according to Public Law 107-188 of the United States: 1. Alcohol and alcoholic beverages; 2. Baby and children's food; 3. Bread and pastries; 4. Beverages; 5. Candy products (including chewing gum); 6. Cereals and ready to eat cereals; 7. Cheese and cheese products Food enterprise registration procedure: 1. Email and fill out the "FDA Registration Application Form" and "Entrustment Agreement". Please read the "Entrustment Agreement" carefully. If your company agrees, we will sign two copies of the "Entrustment Agreement" as the basis for us to provide services to your company. And send the FDA Registration Application Form via email

The US FDA has released proposed rules to ensure the safety and effectiveness of sunscreen products

The US Food and Drug Administration (FDA) has released a proposed rule that will become part of the FDA's final bill to implement over-the-counter (OTC) sunscreen, recognizing two "GRASE" sunscreen ingredients and two "non GRASE" sunscreen ingredients, and requiring data on an additional 16 active ingredients.

On February 21, 2019, the FDA issued a proposed rule to update regulatory requirements for over-the-counter (OTC) sunscreen products marketed in the United States.

The proposed rule includes several endpoints for over-the-counter sunscreen to ensure easy identification of key features of commercially available products, including

• Safety of active ingredients

• Dosage form

Sunscreen index and broad-spectrum requirements

• Test changes

• Record keeping obligation

• Label requirements

The proposed rule specifies two active ingredients, namely zinc oxide and titanium dioxide. They are usually considered GRASE products and can be used as active ingredients in over-the-counter sunscreen. Meanwhile, for safety reasons, the proposed rule also informs that aminobenzoic acid and salicylic acid TEA salt are not "recognized safe and effective" sunscreen ingredients.

The US FDA has not yet conducted GRASE testing on the remaining 12 ingredients, citing that the safety data collected at this stage is insufficient to ensure a judgment at this time. The FDA has requested additional data and published guidance documents to ensure that major companies are aware of the various requirements required for GRASE determination. The remaining 12 components include:

• Sinoxacin ester

• Diphenylene-8

• Phenylbenzimidazole sulfonic acid

HuMo Liu ester

• Menthol ortho aminobenzoate

• Ethylhexyl methoxycinnamate

• Ethyl hexyl salicylate

• Oaklin

• Dimethylaminobenzoic acid

• Diphenylone-4

• Ketone-3

• Avobenzone

In addition to updating the status of active ingredients, the proposed rule also attempts to clarify several other aspects. The proposal believes that GRASE dosage forms include spray, oil, lotion, cream, gel, butter, paste, ointment and stick. At this time, wipes, wet wipes, shower gel, shampoo, and other formulations are not included. Due to the lack of existing data, these formulations will be classified as new drugs. The powder is classified as a dosage form that requires additional safety/efficacy data to support GRASE determination. The particle size requirements for sprays and powders are also proposed.

Other changes include:

• Increase the maximum sun protection index value on the label from 50+to 60

Set the maximum formula requirement of SPF 80 before necessary new drug application

Require the SPF of sunscreen to be 15 or above to provide corresponding broad-spectrum protection

When the SPF index increases, spectral products are required to provide additional protection accordingly

Add active ingredient information at the front end of product packaging

• Consider combination sunscreen and deworming products as non GRASE products

At the same time, several proposals related to final product testing and record keeping were also put forward. Among them, the most far-reaching proposals include:

Products with SPF 15 and above should be labeled with an SPF index, which corresponds to the lowest index in a series of SPF test results;

Add ratio requirements to the in vitro broad-spectrum testing standards;

A new definition of responsible person and a requirement for the responsible person to keep records of certain sunscreen products;

• Require all additional documents to be prepared for FDA inspection;

• Require that the preliminary unprotected drugs do not exceed the standard on the day before testing;

Revisions related to informed consent of test subjects and IRB study approval;

Register and register enterprises that conduct final formula testing;

Revise accordingly so that (in certain existing cases) SPF clinical studies should not involve individuals who have been exposed to ultraviolet radiation or have participated in another SPF clinical study for at least the past four weeks or longer.

The US FDA releases final rules on the safety and effectiveness of hand sanitizers for consumers

The US FDA has completed the determination of 28 active ingredients and postponed the ruling on three active ingredients.

The US Food and Drug Administration (FDA) has issued final rules for consumer use of antibacterial agents (commonly known as hand sanitizers).

As part of the final rule, the FDA found that 28 active ingredients belong to Class II (usually not considered safe or effective, or may cause labeling errors). And it is believed that the non specialized status of these ingredients has an impact of less than 3% on the existing hand sanitizers on the market. These Class II components include:

Currently, the three components that have been postponed for further rule making are:

-Ethanol

-Isopropanol

-Benzalkonium chloride

These have been postponed in order to develop and submit new safety and efficacy data records for these three ingredients.

As the final part of this rule, the FDA has officially updated the statistical analysis of effectiveness, requiring the continued use of bacterial logarithmic reduction studies to demonstrate the effectiveness of active ingredients in consumer antimicrobial agents, and requiring subjects to be randomly assigned to three arm studies:

1. Testing

2. Active control

3. Negative control

In addition, statistical analysis related to logarithmic reduction criteria for classifying antimicrobial active ingredients used by consumers is generally considered effective (GRAE).

Other requirements for updating effectiveness testing include:

-The tested product should not be lower than the FDA approved antibacterial agent as the active control, with a limit of 0.5 (log10 units)

-Require the tested product to be superior to the negative control, with a limit of 1.5 (log10 units)

-The minimum sample size for each treatment group is 100 subjects,

Adequate and well controlled clinical simulations of key consumer antimicrobial agents must be conducted by independent primary researchers in two separate laboratories

Please consult NormalTCI for specific questions

National service hotline: 400-6177-880

Email：service@normaltci.com