- Conformance Assessment
- Declaration of Conformity to a Recognized Standard
- Content/Format of an Abbreviated 510(k)
- Alternate 510(k) Format – STED Pilot Program
- Where to Submit a 510(k)
- Frequently Asked Questions
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 Abbreviated 510(k) relies on the use of guidance documents, special controls, and recognized standards. An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87 (Information required in a premarket notification submission). Under certain conditions, you may not need to submit test data in an abbreviated 510(k).
Device manufacturers may choose to submit an Abbreviated 510(k) when:
- a guidance documents exists,
- a special control has been established, or
- FDA has recognized a relevant consensus standard.
In an Abbreviated 510(k) submission, manufacturers elect to provide summary reports on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards, to expedite the review of a submission.
FDA has developed numerous device-specific guidance documents with public participation. The main focus of these guidance documents is the identification of the information recognized as appropriate for marketing authorization for the device. You can search the guidance document page for an appropriate guidance document.
An Abbreviated 510(k) that relies on a guidance document should include a summary report that describes adherence to the relevant guidance document and how the guidance document was used during device development and testing. The summary report should include information regarding the manufacturer's efforts to conform with the guidance document and should outline any deviations.
Special controls are a means of providing reasonable assurance of the safety and effectiveness a Class II device. Special controls are defined in section 513(a)(1)(B) of the federal Food, Drug & Cosmetic Act (Act) as those controls, such as performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations and other appropriate actions that provide reasonable assurance of the device's safety and effectiveness. The device classification regulations list special controls for the device, if any. The device classification regulations are available in the product classification database.
An Abbreviated 510(k) that relies on a special control(s) should include a summary report that describes adherence to the special control and how the special control(s) was used during device development and testing, including how the special control(s) was used to address a specific risk or issue. The summary report should include information regarding the manufacturer's efforts to conform with the special control(s) and should outline any deviations.
FDA Recognized Standards
In addition to device-specific guidance documents and special controls, CDRH is committed to recognizing individual consensus standards. FDA is authorized to recognize all or part of national and international standards through publication of a notice in the Federal Register. Recognized standards could be cited in guidance documents or individual policy statements, or established as special controls that address specific risks associated with a type of device.
An Abbreviated 510(k) that relies on a recognized standard must include a Declaration of Conformity to the Recognized Standard. Under certain conditions, conformance test data are not required to be submitted in the 510(k).
FDA has recognized approximately 400 standards to which 510(k) submitters can declare conformity. A current list of FDA recognized standards and guidance on the recognition and use of consensus standards can be found on CDRH's Standards website.
If FDA determines that an Abbreviated 510(k) is not eligible for review as submitted, the reviewer will notify the firm of this decision and offer the option of having the document converted to a Traditional 510(k) or withdrawing it for future submission. Please note if you withdraw your 510(k) and resubmit, a new user will apply. If the 510(k) is converted, the original receipt date remains as the start of the review period. Manufacturers should be aware that, in most cases, additional information will be necessary for converted documents.
In the Abbreviated 510(k) process, a manufacturer must assess conformance of the device with a recognized standard. Once the manufacturer has ensured the satisfactory completion of this process, the Abbreviated 510(k) may be submitted.
The manufacturer has the option of using a third party to assess conformance with the recognized standard. (This use of a third party should NOT be confused with the Agency's Third Party Review Program where recognized third parties review entire 510(k) submissions.) Under this scenario, the third party will perform a conformance assessment to the standard for the device manufacturer and should provide the manufacturer with a statement to this effect.
The Abbreviated 510(k) should include a declaration of conformity signed by the manufacturer, while the statement from the third party should be maintained in the Device Master Record (DMR) pursuant to the Quality System Regulation (21 CFR 820). Responsibility for conformance with the recognized standard, however, rests with the manufacturer, not the third party.
In preparing a declaration of conformity to recognized standards, manufacturers should refer to the guidance document, "Recognition and Use of Consensus Standards." Declarations of conformity to recognized standards should include the following:
- An identification of the applicable recognized consensus standards that were met;
- A specification, for each consensus standard, that all requirements were met, except for inapplicable requirements or deviations noted below;
- An identification, for each consensus standard, of any way(s) in which the standard may have been adapted for submission to the device under review, e.g., an identification of an alternative series of tests that were performed;
- An identification, for each consensus standard, of any requirements that were not applicable to the device;
- A specification of any deviations from each applicable standard that were applied (e.g., deviations from international standards which are necessary to meet U.S. infrastructure conventions such as the National Electrical Code (ANSI/NFPA 70);
- A specification of the differences that may exist, if any, between the tested device and the device to be marketed and a justification of the test results in these areas of difference; and
- The name and address of any test laboratory or certification body involved in determining the conformance of the device with the applicable consensus standards and a reference to any accreditations of those organizations.
CDRH recommends that you follow the Abbreviated 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 an Abbreviated 510(k) are reiterated below and are described in the guidance.
- Medical Device User Fee Cover Sheet (Form FDA 3601). See 510(k) Review Fees510(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*
- *Beginning December 26, 2007, all 510(k) submissions must include a completed copy of form FDA-3674. 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 [PDF] 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)
- Provide 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, appropriate 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.
- indications for use of the device,
- proposed label, labeling, and advertisements for the device and directions for use.
- For a submission that relies on a guidance document and/or special control(s), provide a summary report that describes how the guidance and/or special control(s) were used to address the risks associated with the particular device type. (If a manufacturer elects to use an alternative approach to address a particular risk, sufficient detail should be provided to justify that approach.);
- For a submission that relies on a recognized standard, provide a Declaration of Conformity to a Recognized Standard;
- Provide data/information to address issues not covered by guidance documents, special controls, and/or recognized standards; and
- Provide 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.
You should place your 510(k) in a temporary, inexpensive binder. DO NOT permanently bind the submission. 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 which will provide a signed receipt of delivery, e.g., registered mail with a return receipt or a commercial delivery service. Submitters should receive an acknowledgment letter from FDA, including the assigned 510(k) number, within one week of delivery. 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 submission. Information on how to submit the fee can be found at 510(k) Review Fees.
Can FDA rely on a declaration of conformity for a substantial equivalence determination in an Abbreviated 510(k) if the manufacturer states that they will conform rather than they are in conformance?
A declaration of conformity to a recognized standard must certify that the device is in conformance. Therefore, in order for the FDA to rely upon a declaration of conformity to a standard in making a substantial equivalence (SE) determination in an Abbreviated 510(k), the declaration must indicate that the submitter is in conformance. That is, a manufacturer may not state that they will conform at some future date, but rather conformance must have already been determined at the time the submission is submitted.
What happens if an Abbreviated 510(k) includes a statement indicating that the device will conform but is not yet in conformance with a standard?
As stated above, for issues material to the substantial equivalence determination, FDA would not be able to rely upon such a statement. A declaration of conformity certifying that the device is in conformity to the standard would be needed.
The only exception to the above would be for cases where substantial equivalence had previously been demonstrated for devices of this type without conformance to the standard. For example, if a manufacturer states that a device will conform to IEC-60601-1-2 Electromagnetic Compatibility and substantial equivalence for the predicate device had been determined without conformance to the standard, then the submission could be reviewed as an Abbreviated 510(k). If, as stated above, conformance to this standard is integral to the SE determination, then conformance would need to be established before the 510(k) is submitted.
What advantage, if any, is there for a firm to use a third party to assess conformance with recognized standards? If a firm does use a third party for the assessment, should this information be included in the 510(k) submission?
Many device manufacturers employ third parties in assessing conformance with standards as a matter of routine practice. Although it is ultimately the submitter's responsibility for assuring conformance when electing to submit a declaration of conformity in a premarket submission, third party involvement may provide the manufacturer with added confidence when submitting a declaration and provide the FDA with additional assurance of conformance. Involvement by an independent, technically competent third party can only benefit the overall process.
An Abbreviated 510(k) with a Declaration of Conformity to a Recognized Standard should include the name and address of any test laboratory or certification body involved in the conformance assessment as well as a reference to the accreditation of the third party as stated in Attachment 4 of the The New 510(k) Paradigm. FDA recommends that 510(k) submitters follow Attachment 4, when preparing declarations of conformity to standards. That is, declarations of conformity to standards should include the name, address, and accreditation of all third parties involved in the conformance assessment. If a manufacturer uses a third party to perform a conformance assessment of standards, this information should be maintained in the firm's device master record (DMR).
What happens if the FDA determines that an Abbreviated 510(k) can not be reviewed as such? Is the submission rejected? Is the review clock reset?
If the FDA determines that an Abbreviated 510(k) is not eligible for review as submitted, the reviewer will notify the firm of this decision and offer the option of having the document converted to a Traditional 510(k) or withdrawing it for future submission. If the 510(k) is converted, the original receipt date remains as the start of the review period. Manufacturers should be aware that, in most cases, additional information will be necessary for converted documents.
Is the 30 day review clock for Special 510(k)s also applicable to Abbreviated 510(k)s?
No. While the FDA expects that declarations of conformity to standards will reduce the review time for Abbreviated 510(k)s compared to Traditional 510(k)s, FDA has not established a 30 day review clock for Abbreviated 510(k)s.
Could a submitter be held liable if a declaration of conformity to a standard is based on information that turns out to be false? What if the information was provided to the submitter by a third party? What are the consequences of submitting a false declaration of conformity?
Yes. Submitting a false declaration of conformity to a standard is specifically identified as a prohibited act in section 301(x) of the Act. If it is determined that the information underlying the declaration of conformity is false or misleading in any material respect, the submitter of the declaration could be held liable. This is true whether the information was generated by the submitter or by a third party (e.g., a testing facility). Therefore, it is important that a person declaring conformity to a standard carefully review the information forming the basis for the declaration before it is submitted to the FDA.
However, the FDA does wish to distinguish a "false" or "misleading" declaration of conformity from a declaration of conformity in which FDA disagrees with the adequacy of the supporting data. The FDA acknowledges that a manufacturer may make a good faith effort to conform with a standard and yet FDA may disagree with the basis upon which the declaration was made. Under such circumstances, the FDA will make every effort to resolve the issue with the submitter.
During the review of a 510(k), does FDA anticipate that it will routinely ask for the data or information supporting a declaration of conformity to a standard?
FDA may request, at any time, data or information relied upon for the declaration of conformity. FDA does not, however, expect that this would routinely occur, but rather only on a case-by-case basis if a serious concern arises during the review of the submission. The concurrence of senior management would be needed before such a request would be made. [Section 514 of the Act]
How long should the records supporting a declaration of conformity to a standard be maintained?
Persons declaring conformity to a standard must maintain data and information demonstrating conformity of the device to the standard for two years after the date of the substantial equivalency determination or for a period equal to the expected design life of the device, whichever is longer. [Section 514 of the Act]
- Format for Traditional and Abbreviated 510(k)s
- The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
Guidance for Industry: Frequently Asked Questions on the New 510(k) Paradigm Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards Frequently Asked Questions on Recognition of Consensus Standards FDA Recognized Consensus Standards Database