Annual FDA Medical Device Registration Fee Increases and New OTC Drug Registration Fees in 2021

Release time:

2020-09-22 17:36

With the time coming to September 2020, the annual FDA medical device factory registration fee will be paid by October 1, 2020 to December 31, 2020. All factories and businesses must pay a factory registration fee. There is no fee waiver for small businesses or factories. The factory registration fee for the new year has risen to $5546.

What is more noteworthy is that FDA plans to charge fees for the original free OTC drug registration from 2021, which will add an additional fee to Chinese manufacturers of disinfectant wipes, hand sanitizer, fluoride toothpaste, sunscreen, etc. that have been exported to the United States through OTC registration. The specific cost standard will be announced soon, and the new Anrun Consulting will continue to release the latest FDA developments, so stay tuned.

FDA small business qualification refers to that the company's total revenue or sales in the latest tax year does not exceed US $0.1 billion, and it needs to apply for FDA small business qualification certification 1-2 months in advance before it can enjoy small-scale business preferential treatment. Small businesses have strong preferential treatment in PMA application, De Novo classification request, 510(K) application and 513(g) device classification information request application in FDA, but do not involve annual fee reduction or exemption for factory registration.

In the United States, hand sanitizer is an over-the-Counter (OTC) for local disinfection. Like anti-dandruff shampoo, fluoride toothpaste, sunscreen and other products, it is regulated by FDA.

Any OTC product on the market must meet certain conditions, otherwise it will be treated as an NDA. Drugs containing these active ingredients can directly apply for NDC and sell them on the OTC market without applying for NDA. At present, there are hundreds of active ingredients permitted by the US FDA to be used in OTC. The US FDA's management and identification of OTC ingredients are all published in the Federal Register. The relevant provisions amount to tens of volumes and hundreds of thousands of pages. Studying the management methods of US OTC is the professional work of professional lawyers and consultants. The NDC number applying for OTC must be seated accordingly.

New Anrun Consulting can provide export enterprises with all kinds of epidemic prevention materials exported to the United States FDA services:

For OTC products under the US FDA, the following services can be provided:

• apply for a Dun & Bradstreet number;

• Site registration;

• Apply for NDC;

• FDA product filings;

• Product label review.

Products exported to the United States to see, here are the certification you need!

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Products exported to the United States to see, here are the certification you need!

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