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 US
FDA : The
“Traditional”510(k)
- Part
IV
In the last column, we discussed the new FDA User Fee requirements and began discussion of the "Traditional" Premarket Notification (510(k)) submissions to the FDA.
In this column, we will update you of the new User Fees, Registration and Listing requirements and review the contents of the "Traditional" 510(k).
User Fee Update
The FDA now charges a fee to review many types of submissions, including 510(k)s, Premarket Approvals (PMAs), Product Development Protocols (PDPs), Premarket Reports (PMRs) and Biologics Licensing Applications (BLAs). The FDA announced that the User Fee for 510(k)s will be increased to $3,480.00 on October 1, 2003! The cost of submitting a PMA will increase on that date to $206,811.00. Small businesses in the United States only can apply for a reduced fee. More complete information can be found at this link:
http://www.fda.gov/cdrh/mdufma/index.html
. (Also, See Archives.)
Registration and Listing
The FDA now requires all foreign contract manufacturers and contract sterilization facilities to submit both Initial Registration of Device Establishment forms and Device Listing forms. In addition, a new regulation (21 CFR 807.40) states that each foreign establishment may designate
only one United States agent who is either a resident of the United States or maintains a place of business in the United States. (The foreign establishment may, but is not required to, designate its United States agent as its Official Correspondent). The Official Correspondent submits and updates registration and device listing forms. (See Archives and
http://www.fda.gov/cdrh/usagent/
for more details).
A contract manufacturer is a company that manufactures a finished device to another establishment's specifications. A contract sterilizer is a company that provides a sterilization service for another establishment's devices. (See
Archives)
Contents of the 510(k)
1. Cover Sheet
It is a good idea to have a cover sheet on company letterhead that gives the name of the device that is the subject of the 510(k) and the full name and address of the company.
2. Table of Contents
The table of contents should list each required item with page numbers and Dividers (I use numbered dividers). Also, include a list of any attachments and appendices.
3. Cover Letter
A cover letter should follow the Cover sheet. It will normally be on the letterhead of the consultant preparing the 510(k) submission or on the company letterhead if it is being prepared by the company personnel.
Here is the format I use for the cover letter:
(a) Date of the 510(k) Submission
(b) Address of the FDA
Document Mail Center
Office of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration
HFZ-401
9200 Corporate Blvd.
Rockville, MD 20850
(c) Attention Block
Below the address, on the right, I place the following information to ensure the document is processed correctly:
Attention: Document Control Clerk
Type of Submission: 510(k) Notification
Product: (Put in tradename of your device)
Reason for Submission: New Device
(d) Notification
This is the statement I include:
"In accordance with Section 510 (k) of the Federal Food and Drug Cosmetic Act as amended, and in conformance with Title 21 CFR, Part 807, this Pre-market Notification is being submitted at least ninety (90) days prior to the date when
(include Sponsor name) proposes to introduce its (include tradename of the
device) into interstate commerce for commercial distribution."
(e) Sponsor Identification
Include the complete address, telephone, fax numbers and e-mail address of the sponsor (applicant).
(f) Sponsor Establishment Registration Number
Put in this or your Owner/Operator Number if you have it. Remember to have your official correspondent submit a manufacturer registration form for your company. Registration is not required to submit a 510(k) but is required within 30 days of marketing the product in the United States.
(g) Official Contact Person
This is the person preparing the 510(k) to whom all FDA questions and letters will be submitted. This person can be your consultant or a company official. He or she assists you by contacting the FDA to learn more about the nature of any requests for additional information or questions on the submission from the FDA. The official contact person can then explain to your company what is needed to satisfy the FDA. Include his or her complete address, telephone, fax and e-mail addresses. Remember to contact the FDA in writing of any changes in the sponsor, contact person or addresses. Only the sponsor or contact person can make such changes.
Include the 510(k) document control number in your letter.
(h) Address(es) of Manufacturing and Sterilization Site(s), if Appropriate
(i) Confidentiality
I always include the following statement:
"We consider our intent to market this device to be confidential commercial information and, therefore, exempt from public disclosure. To the best of my knowledge, neither anyone nor I has disclosed through advertising or any other manner, our intent to market the device to scientists, market analysts, exporters, or any other individuals, except employees of, or paid consultants to, our company or individuals in an advertising or law firm pursuant to commercial arrangements with appropriate safeguards for secrecy.
We have taken precautions to protect the confidentiality of the intent to market the device. We understand that the submission to the government of false information is prohibited by U.S.C. 1001 and 21 U.S.C. 331(q)."
(j) Signature of Official Contact Person or Sponsor and Title
4. Truthful and Accurate Statement.
All Sponsors must sign a statement certifying that all information submitted in the 510(k) is truthful and accurate and that no material fact has been omitted. Your consultant cannot sign this form. This Truthful & Accurate Statement must be listed in the table of contents, as a separate item. Here is a link to the Truthful & Accurate Statement: http://www.fda.gov/cdrh/manual/stmnt1.html.
5. Indications for Use
It is extremely important that this statement be prepared carefully. A copy of this form will be returned to you with the letter declaring your product to be substantially equivalent to the predicate device and, therefore, legally marketable in the United States (subject to the restrictions noted in the letter). You will be limited in marketing your product to only the claims in your Indications for Use statement.
The Indications for Use form must be listed in the table of contents, as a separate item.
We will begin the next column with a discussion of the contents of the Summary of Safety & Effectiveness section of the 510(k) In the meantime, stay safe and healthy!
Norman F. Estrin, Ph.D., RAC
August 14, 2003
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