In the United States, the FDA also has a "listing" for OTC products that meet the OTC monographs and for low-risk medical device products. (listing) Management mode.
In the United States, the FDA also has a designation for OTC products that comply with the OTC monoograph and for low-risk medical device products. Column name ” (listing) Management mode.
Under what circumstances can products be exempted from listing?
Similar to the exemption for facility registration, there are two circumstances in which product listing can be exempted:
1. Small-scale enterprises, that is, the Responsible Person of the product, belong to small-scale enterprises, and do not belong to some products with higher risk of use. “ Small scale enterprises ” See the Key Requirements for Facility Registration for the definition and specific requirements.
2. The product must also meet the management requirements of drugs or medical devices. If the product is both cosmetic and pharmaceutical, the product does not need to be listed as cosmetic.
What information should be submitted for product listing?
1. The registration number of the enterprise producing and processing products. If the business is exempt from factory registration and does not have a business FEI number, the business name and address can be provided;
2. Responsible person information;
3. Product name;
4. Product category. The classification is provided in the annex to the draft Guide;
5. List of product ingredients, including flavors, fragrances, colorants. There is no mention in the draft Guide of the need to submit the concentrations of the components and presumably no need to provide them;
6. Product column number (applicable to updated scenarios);
7. The nature of the submission, such as initial submission, update, etc.;
* There is also information that is not mandatory to submit, such as labels, links to product websites, whether the product is intended for professional use only, etc.
Where to submit product listing information?
Currently, FDA is developing a new electronic submission platform. After the electronic submission platform is put into use, enterprises can choose to submit electronically or submit paper forms in two ways. But for overseas companies, electronic submission is more convenient.
In addition, the FDA is recruiting cosmetics companies to participate in a private test of the electronic platform.
Can we start the product listing now?
Both the electronic submission platform and the paper submission form have not been officially released, so registration is not yet available, and the FDA estimates that the electronic platform will be launched in October 2023.
Enterprises can start preparing for product listing in advance, including applying for the FEI number of the enterprise, determining the United States agent, sorting out product information, etc.
When does the product listing need to be finished?
Products that have been marketed in the United States before December 29, 2022, shall be submitted for listing by December 29, 2023.
For products first available for sale in the United States between December 29, 2022 and December 29, 2023, the latest submission time is within 120 days after December 29, 2023.
Products first available for sale in the United States after December 29, 2023, should be submitted within 120 days of being available for sale.
Will the product listing information be made public?
According to the draft guidelines, the FDA will not disclose the product listing number and the information of the corresponding manufacturing and processing company, and other information will be disclosed.
Do I need to pay a fee for product listing?
FDA does not charge a listing fee.
Zhongbang Consulting reminds you that the United States must pay attention to the relevant content of the draft, you can prepare for the product listing in advance, so as not to affect product sales.
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