Before apostille a 510(K) Clearance Letter you obtained from the FDA, you'll need to get a notarized copy of the 510(K) Clearance Letter first.
1. What is 510(K) Clearance Letter?
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.
2. What is notarization?
In the US, a notary public commissioned by the state government certifies the authenticity of any signatures appended to a document. Notaries act as government agents to verify the signer's ID, and ensure the signer's willingness to sign without duress or intimidation and the signer's awareness of the document's contents. This notarization process guarantees the authenticity of the signature and helps deter fraud. In this case, you need to bring the 510(K) Clearance Letter and a self-prepared "True Copy Affidavit" (click to see the sample) to a local notary. When requesting true copy notarization, prepare a copy in advance, or in some cases, the notary will make a copy of your original document. You'll sign an affidavit in front of the notary. The notary will verify your identity, witness the signature, fill in the notarial wording, and sign and affix his or her seal on the document. Click here to learn how to ensure your document is properly notarized. Contact us (email: firstname.lastname@example.org ) for a free review and to confirm whether your state has special requirements for the content, notarial wording, etc.
3. What is an apostille?
An Apostille is for documents to be used in countries that participated in the 1961 Hague Convention Treaty. Once complete, no more steps are needed. Authentication certificates are for documents to be used in countries that do not participate in the 1961 Hague Convention Treaty. An Apostille is a simplified form of Authentication and usually needs only one competent authority to be involved. Once complete, no more steps are needed. Yet Authentication may go through a multi-step process to get the certificate from those foreign embassies or consulates in the US.
4. Apostille or Authentication Process
As mentioned before, the destination country of your document will decide which certificate you should obtain. If the destination country is a Hague Apostille country/region (such as Germany, Spain, France, etc.):
Get an Apostille from the Secretary of State's office.
If the destination country is NOT a Hague Apostille country/region (such as mainland China, Taiwan, Canada, etc.):
Get an Authentication from the Secretary of State in your state.
Get an Authentication from the U.S. Department of State. (if required)
Get a Legalization from the Embassy.
Simply place the order based on your situation and mail us the original notarized copy of your 510(K) Clearance Letter. We will contact the right people and departments to apostille or authenticate it. The apostille and authentication process can be complicated. If you don't want to spend a lot of time and energy getting into it, your best bet is to let a professional do it for you. Once we receive your order and document, it'll be processed as soon as possible. Besides the 510(K) Clearance Letter, we also provide apostille, authentication, and embassy legalization services for other personal documents and corporate documents issued in 50 states and DC.
American Notary Service Center Inc. provides fair, fast, confidential, and professional document notarization and certification services for our clients. We also provide various assistance services to small businesses led by socially and economically disadvantaged groups. Our service helps small businesses obtain federal government contracts, gain a foothold in the market, and boost their sales. For more information, please visit our website at www.usnotarycenter.com, and contact us by calling 202-599-0777 or by email at email@example.com.