How to Prepare a Traditional 510(k)
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under "The New 510(k) Paradigm" to help streamline the 510(k) review process. The Special 510(k) and Abbreviated 510(k) methods can only be used if certain criteria are met. The Traditional 510(k) method can be used under any circumstances.
There is no Premarket Notification 510(k) "form" to complete. A 510(k) is a document containing information required under 21 CFR 807 Subpart E. All 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed (predicate) device. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices.
You should identify a predicate device or devices to which you will compare your device. We strongly recommend that the 510(k) number of the predicate device be identified. Use a device(s) that is as similar to your device as possible. (You may claim equivalence to more than one predicate, if necessary). A predicate device will usually be a recently cleared device. Please refer to How to Find a Predicate Device for additional guidance.
FDA has published many device specific guidance documents as well as general guidance for biocompatibility, software contained in medical device, electromagnetic compatibility, etc. These documents are available through the Guidance Documents page.
Device specific guidance documents describe in detail the information which should be included in the 510(k) to enable FDA to determine SE for that particular type of device. These guidance documents should be consulted at the device planning stage. In addition, the design control requirements (21 CFR 820.30) of the Quality System regulation should be reviewed as well since much of the information and data developed to meet design controls is the same information included in the 510(k).
A Traditional 510(k) submission must include the required elements identified in 21 CFR 807.87 (Information required in a premarket notification submission). CDRH recommends that you follow the Traditional 510(k) format provided in the guidance document, "Format for Traditional and Abbreviated 510(k)s." The guidance document will help you create a complete 510(k). Pertinent elements of a Traditional 510(k) include:
- Medical Device User Fee Cover Sheet (Form FDA 3601). See 510(k) Review Fees for additional information on review fees.
- CDRH Premarket Review Submission Cover Sheet [PDF]
- Certification of Compliance with ClinicalTrials.gov Data Bank, FDA-3674*
- The agency has issued for comment a draft guidance, titled: “Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007”. According to the draft guidance, 510(k) submissions that do not contain clinical data do not need the not need the certification form. Anyone wishing to comment on the draft guidance is requested to submit electronic or written comments within 60 days. See Form FDA-3674, ClinicalTrials.gov Data Bank for additional information.
- Cover letter as described in the format guidance
- Table of Contents (recommended)
- Indications for Use. See Determination of Intended Use for 510(k) Devices (Update to K98-1) for additional information on indications for use.
- 510(k) Summary (21 CFR 807.92) or 510(k) Statement (21 CFR 807.93)
- Standards Data Report for 510(K)s - FDA 3654. Submit this form if your 510(k) references a national or international standard.
- Truthful and Accuracy Statement (21 CFR 807.87(k))
- Class III Certification and Summary for Class III devices (21 CFR 807.94)
- Items required under 21 CFR 807.87 (Information required in a Premarket Notification submission), including
- the name of device, include the trade or proprietary name, if any, and the common or usual name or classification name of the device. Provide what you believe to be the classification of the device, approprate panel (e.g. cardiovascular, dental, etc.), and product code, if known.
- description of the device, include device specifications and reference applicable guidance documents, special controls, or standards; photographs or engineering drawings should be supplied, if applicable
- comparison with a predicate device(s), indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.
- intended use of the device,
- proposed label, labeling, and advertisements for the device and directions for use.
- Information on sterilization, biocompatibility, expiration date, etc., if applicable.
As an alternative to the submission format described in “ Format for Traditional and Abbreviated 510(k)s,” you may submit your 510(k) in the globally harmonized format described in the document entitled “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices.” The document was developed by Study Group 1 (SG1) of the Global Harmonization Task Force (GHTF). See the FDA guidance, A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures for a description of the FDA pilot program and the eligible device types.
If you choose to submit a 510(k) in the STED format, the information about Traditional 510(k)s in “Format for Traditional and Abbreviated 510(k)s,” may help you prepare your STED submission. Appendix C shows the correlation between the sections recommended in this guidance and the STED format.
A 510(k) should be put in a temporary, inexpensive binder. DO NOT permanently bind the application. FDA will take the submission out of whatever binding in which it was submitted, 3-hole punch the left margin, and put the 510(k) in a 3-ring "jacket" for review. Paper size should be 8.5 inches by 11 inches.
You must submit two copies of your 510(k) to the address below. One of your two copies must be submitted in electronic format. FDA does NOT return the 510(k) submission after review. You should retain a copy of your 510(k) for your records. Submissions should be sent to:
Food and Drug Administration *
Center for Devices and Radiological Health
Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
We recommend that you send your 510(k) to FDA by a method that will provide a signed receipt of delivery, e.g., registered mail with a return receipt or a commercial delivery service. You should receive an acknowledgment letter from FDA, including the assigned 510(k) number, within two weeks of delivery. If after 2 weeks you have not received the 510(k) acknowledgement letter, contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) for assistance. 510(k) Submission Process describes the review process after the submission is received by FDA.
Traditional, Special, and Abbreviated 510(k)s require the same 510(k) review fee. Do NOT send the fee with the application. Information on how to submit the review fee can be found at 510(k) Review Fees.