Medical Devices

How To Prepare A Special 510(k)


Overview
 

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.

Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls.

The "Special 510(k): Device Modification" utilizes the design control requirement of the Quality System Regulation (21 CFR 820) and may be submitted for a modification to a device that has been cleared under the 510(k) process. The Special 510(k) allows the manufacturer to declare conformance to design controls without providing the data. While the basic content requirements of the 510(k) (21 CFR 807.87) remain the same, this type of submission should also reference the cleared 510(k) number and contain a "Declaration of Conformity" with design control requirements. Manufacturers of Class I devices requiring 510(k) may elect to comply with the design control provision of the QS regulation and submit Special 510(k)s.

Manufacturers of preamendments devices may also submit Special 510(k)s. When the legally marketed (unmodified) device is a preamendments device, the submitter should clearly state that the device is a preamendments device, is legally marketed, and has not been the subject of Premarket Notification 510(k) clearance. (Refer to "Documentation Required for Preamendments Status" for the procedures for demonstrating preamendments status. Submitters should maintain this information in their files.)

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Background

Effective June 1, 1997, manufacturers of Class II, Class III, and certain Class I devices are required to follow design control procedures when originally developing devices and for subsequent modifications. In accordance with the Quality System Regulation, manufacturers must have a systematic set of requirements and activities for the management of design and development, including documentation of design inputs, risk analysis, design output, test procedures, verification and validation procedures, and documentation of formal design reviews. In this process, the manufacturer must ensure that design input requirements are appropriate so the device will meet its intended use and the needs of the user population. The manufacturer must also establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Thus, manufacturers may need to refine their device design requirements as verification and validation results are obtained. The design specifications that result from this process are the design outputs, which form the basis for the device master record (DMR). [See 21 CFR 820.3(i)] The DMR is subject to inspection by FDA personnel.

Since design control requirements are now in effect and require the manufacturer to conduct verification and validation studies of a type that traditionally may have been included in 510(k) submissions in the past, FDA believes that it may be appropriate to forgo a detailed review of the underlying data normally required in the 510(k) program. For this reason, FDA is allowing an alternative to the traditional method of demonstrating substantial equivalence for certain device modifications. For these well-defined modifications, FDA believes that the rigorous design control procedure requirements produce highly reliable results that can form, in addition to the other 510(k) content requirements, a basis for the substantial equivalence determination. Under the Quality Systems Regulation, data that is generated as a result of the design control procedures must be maintained by the manufacturer and be available for FDA inspection.

In order to provide an incentive for manufacturers to choose this option for obtaining FDA clearance for device modifications, the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) intend to process Special 510(k)s within 30 days of receipt by the Document Mail Center (DMC). The Special 510(k) option allows FDA to review modifications that do not affect the device's intended use or alter the device's fundamental scientific technology within this shorter time frame. FDA does not believe that modifications that affect the intended use or alter the fundamental scientific technology of the device are appropriate for review under this type of submission, but rather should continue to be subject to the traditional 510(k) procedures [i.e., "Traditional 510(k)") or may be subject to an Abbreviated 510(k)].

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Criteria for a Special 510(k)

Under the New 510(k) Paradigm, a manufacturer should refer to 21 CFR 807.81(a)(3) and the FDA guidance document entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device," to decide if a device modification may be implemented without submission of a new 510(k). If a new 510(k) is needed for the modification and if the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device, then summary information that results from the design control process can serve as the basis for clearing the application along with the required elements of a 510(k) found in 21 CFR 807.87.

To optimize the chance that a Special 510(k) will be accepted and promptly cleared, 510(k) submitters should evaluate each modification against the considerations described below to insure that the particular change does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

Intended Use

Modifications to the indications for use of the device or any labeling change that affects the intended use of the device will not be accepted as a Special 510(k). Therefore, FDA recommends that submitters of Special 510(k)s highlight, or otherwise prominently identify, all changes in the proposed labeling that may result from modifications to their legally marketed device. In addition, it should be clearly stated in the Special 510(k) that the intended use of the modified device, as described in its labeling, has not changed as a result of the modification(s). Please note that a labeling change from prescription use to over the counter use, or vice versa, is considered a change in intended use and, therefore, is not eligible for the Special 510(k) method.

Fundamental Scientific Technology

Special 510(k)s also will not be accepted for modifications that have the potential to alter the fundamental scientific technology of the device. These types of changes generally include modifications to the device's operating principle(s) or mechanism of action, such as automation of a manual device or incorporation of a sensing or feedback circuit. Specific examples that illustrate these types of changes that alter the fundamental scientific technology and thus should not be submitted as Special 510(k)s include:

  1. A change in a surgical instrument that uses a sharpened metal blade to one that cuts with at a laser;
  2. A change in an in vitro diagnostic (IVD) device that uses immunoassay technology to one that uses nucleic acid hybridization or amplification technology;
  3. Incorporation of a sensing mechanism in a device to allow the device to function "on demand" rather than continuously.

In addition, FDA is concerned with changes in materials in certain devices. While FDA acknowledges that many such changes can be processed as Special 510(k)s, there are certain types of changes in materials that may raise safety or effectiveness issues that continue to warrant a more intensive evaluation. This includes a change in material(s) in an implant, or other device that contacts body tissues or fluids, to a material type that has not been used in other legally marketed devices within the same classification regulation for the same intended use (i.e., "legally marketed predicate device"). For example, a change in a material in a finger joint prosthesis from a known metal alloy to a ceramic that has not been used in a legally marketed predicate, should not be submitted as a Special 510(k). Similarly, a change in a device's active ingredient or agent to one that has not been used in other legally marketed predicate devices should not be submitted for review as a Special 510(k). For example, if a manufacturer of a contact lens disinfecting solution wanted to change from hydrogen peroxide to an antiseptic that had not been previously used in a legally marketed predicate, such a change would not be appropriate for review as a Special 510(k). Both of the above types of modifications involve major changes in the principle component of the device and thus would be considered a change to the fundamental scientific technology of the device and should be submitted for review as either Abbreviated or Traditional 510(k)s.

A change, however, in formulation in a material or a change to a type of material that has been used in other legally marketed devices within the same classification regulation for the same intended use could be reviewed as a Special 510(k). This should be true for both non-contacting devices as well as implants and devices that contact body tissues or fluids. Thus, a manufacturer of a hip implant could change from one alloy to one that has been used in another legally marketed predicate through the submission of a Special 510(k). Similarly, a contact lens manufacturer could submit a Special 510(k) for a change in their polymer to another material that has been used in a legally marketed predicate. Finally, changes in an inactive or secondary ingredient/agent should be appropriate for review as Special 510(k)s as this should not be considered a major change to the fundamental scientific technology of the device. For example, a manufacturer of a urologic catheter could submit a Special 510(k) to add an antimicrobial coating to the device if the coating has been used on another legally marketed predicate of the same material.

Device modifications that should be appropriate for review as Special 510(k)s also include those changes identified below:

  • Energy type
  • Environmental specifications
  • Performance specifications
  • Ergonomics of the patient-user interface
  • Dimensional specifications
  • Software or firmware
  • Packaging or expiration dating
  • Sterilization

It should be noted that in cases where FDA has issued guidance, established special controls, or recognized standards that address issues such as device testing or performance, manufacturers should consider this in their implementation of design control requirements. For example, if a manufacturer is modifying a contact lens, then the manufacturer's design control inputs should include the special controls that FDA has established for this device. Further, if a manufacturer modifies an in vitro diagnostic, the manufacturer's design inputs should include any recognized clinical standards such as those developed by NCCLS (formerly known as National Committee of Clinical Laboratory Standards) or a reasonable alternative. Thus, submitters of Special 510(k)s need to be aware of any relevant guidance documents, special controls, or recognized standards that apply to their device and that should be addressed by their design control processes.

Clinical Considerations

FDA recognizes that clinical evaluation may be involved in the validation of the design of a modified device. Please note that all clinical investigations must conform to the applicable regulations, including 21 CFR Parts 812, 50 and 56. Collection of clinical data to support a Special 510(k) may require submission of an Investigational Device Exemptions (IDE) application to FDA. The fact that a significant risk device investigation was conducted to support any of the activities listed above, however, does not necessarily preclude the submission of a Special 510(k).

Manufacturers who intend to conduct clinical investigations of a modified device as part of design validation are encouraged to contact the appropriate ODE review division before preparing a Special 510(k). When a clinical investigation is necessary to answer safety and effectiveness questions relating to a particular modification, FDA believes that the modification is likely to have gone beyond that which is suitable for review as a Special 510(k). In contrast, where design validation involves clinical evaluation intended to ensure that the modified device meets user requirements as opposed to patient safety and effectiveness or to demonstrate continued conformance with a special control or recognized standard, FDA believes that the Special 510(k) may be the appropriate submission.

If FDA determines that a Special is not eligible for review as submitted, the FDA 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.

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Conformance Assessment

In the Special 510(k) process, a manufacturer who is intending to modify his/her own legally marketed device will conduct the risk analysis and the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements. Once the manufacturer has ensured the satisfactory completion of this process, a "Special 510(k): Device Modification" may be submitted.

Under the Quality System Regulation, manufacturers are responsible for performing internal audits to assess their conformance with design controls. A manufacturer could, however, use a third party to provide a supporting assessment of the conformance. (This use of a third party should not be confused with FDA's Third Party Review Program where recognized third parties review entire 510(k) submissions.) In this case, the third party will perform a conformance assessment for the device manufacturer and provide the manufacturer with a statement to this effect. The marketing application should then 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). As always, responsibility for conformance with design control requirements rests with the manufacturer. Under the Quality Systems Regulation, data that is generated as a result of the design control procedures must be maintained by the manufacturer and be available for FDA inspection.

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Content/Format of a Special 510(k)

A Special 510(k) should be well organized and formatted in sections, with page numbering, and include the required elements:

  • The name of the legally marketed (unmodified) device and the 510(k) number under which it was cleared. Include the trade or proprietary name, if any, and the common or usual name or classification name of the device. Provide the classification of the device, approprate panel (e.g. cardiovascular, dental, etc.), and product code, if known.

    In cases where the referenced 510(k) was submitted under a different name than that of the submitter of the Special 510(k), FDA recommends that a statement to this effect be included in the Special 510(k) and that the submitter maintain adequate information demonstrating his legal right to distribute the device.

    When the legally marketed (unmodified) device is a preamendments device, the submitter should clearly state that the device is a preamendments device, is legally marketed, and has not been the subject of premarket notification clearance. (Refer to "Documentation Required for Preamendments Status" for the procedures for demonstrating preamendments status.) Submitters should maintain this information in their files.

  • Items required under §807.87 (Information required in a Premarket Notification submission), including
    • description of the modified device; where applicable, photographs or engineering drawings should be supplied,
    • comparison to the cleared device 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. It is recommended that submitters of Special 510(k)s highlight, or otherwise prominently identify, all changes in the proposed labeling that may result from modifications to their legally marketed device. In addition, it should be clearly stated in the Special 510(k) that the intended use of the modified device, as described in its labeling, has not changed as a result of the modification(s). Please note that a labeling change from prescription use to over the counter use, or vice versa, is considered a change in intended use and, therefore, is not eligible for the Special 510(k) method.
  • A concise summary of the design control activities. FDA may consider the information generated from these activities to be "appropriate supporting data" within the meaning of §807.87(g). This summary should include the following:
    • An identification of the Risk Analysis method(s) used to assess the impact of the modification on the device and its components as well as the results of the analysis;
    • Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and the acceptance criteria applied; and
    • A declaration of conformity with design controls. (See Attachment 2 of 510(k) Paradigm) Please note that if a recent Quality System inspection has resulted in the issuance of a violative inspection report, the manufacturer should be prepared to describe those corrective actions taken, if needed, that form the basis for the declaration of conformity.

    The declaration of conformity should include:

    1. A statement that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met; and
    2. A statement that the manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. If a recent Quality System inspection has resulted in the issuance of a violative inspection report, the manufacturer should be prepared to describe those corrective actions taken, if needed, that form the basis for the declaration of conformity.

    The above two statements should be signed by the designated individual(s) responsible for those particular activities.

  • Information on sterilization, biocompatibility, expiration date, etc., if applicable.

Tabs may be used to separate each section but in any case each section should begin on a new page. The order in which required elements are presented is less important than completeness. In other words, it is not strictly required that labeling be presented as part of the device specifications, or in a separate section. For additional information, see Content of a 510(k) and Format of a 510(k).

An example of a Special 510(k) can be found in Frequently Asked Questions on the New 510(K) Paradigm.

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Where to Submit a 510(k)

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:

U.S. Food and Drug Administration*
Center for Devices and Radiological Health
Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

* If your device is reviewed by CBER, send your 510(k) to directly to CBER to avoid delays. The list of devices reviewed by CBER is available on Devices Regulated by CBER.

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 Industry and Consumer Education (DICE) 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.

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Frequently Asked Questions

  1. Can FDA rely on a declaration of conformity for a substantial equivalence determination in a Special 510(k) if the manufacturer states that they will conform rather than they are in conformance?

    A manufacturer may not state that it will conform to design controls at some future date, but rather conformance must have already been determined at the time the application is submitted.

  2. What advantage, if any, is there for a firm to use a third party to assess conformance with design controls? 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 design controls 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.

    FDA recommends that 510(k) submitters follow Attachment 2 in The New 510(k) Paradigm when preparing declarations of conformity to design controls. If a manufacturer uses a third party to perform a conformance assessment of design control requirements, the third party information should be maintained in the firm's device master record (DMR).

  3. What happens if the FDA determines that a Special 510(k) can not be reviewed as such? Is the submission rejected? Is the review clock reset?

    If the FDA determines that a Special 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.

  4. For Special 510(k)s, Attachment 2 of The New 510(k) Paradigm guidance document states that the manufacturer's declaration of conformity should include a statement that "all verification and validation activities were performed. . . . " Since some of these activities are not usually performed until just prior to marketing, what activities should be performed prior to submission of the Special 510(k)?

    This statement in the declaration of conformity is intended to capture the manufacturer's compliance with those verification and validation activities that are related to the design modification(s). Therefore, prior to submission of a Special 510(k), FDA would expect that the verification and validation activities, as identified by the risk analysis to ensure that the modified device is as safe and effective as the predicate device, would be completed and would demonstrate that the predetermined acceptance criteria had been met. In accordance with the Quality System Regulation, however, all process validation must be completed and appropriately documented before commercialization of the device.

  5. If a firm obtains clearance for a Special 510(k), will the firm necessarily be inspected to verify conformance with design controls?

    No. The Office of Compliance is developing an audit program to help determine if firms that submitted Special 510(k)s were in fact in conformance with design control requirements. This does not mean, however, that all firms that submit Special 510(k)s will be audited. Under the pilot program, a limited number of cleared submissions will be identified for verification of conformance with design controls by inspection. If a firm is to be inspected, FDA will notify the firm ahead of time and follow established GMP inspection procedures. However, please note that routine GMP inspections for Class II and III devices are required by the statute. Thus, submitters of 510(k)s for such devices are subject to inspection whether the premarket notification is submitted for review as an Abbreviated, a Special, or a Traditional 510(k).

  6. For Special 510(k)s that were submitted but later determined to be ineligible for review as such, what were the most common reasons for this determination?

    The most frequently observed problem with Special 510(k)s has been related to the design control information that was submitted in support of the device modification. Several submissions did not include a complete declaration of conformity to design controls. Other submissions included a statement indicating that the firm would comply with the design control requirements rather than a statement that the firm is in conformance. In a few 510(k)s, it was determined that the firm did not perform a complete risk analysis for the device modification.

    Finally, one of the other problems observed with the Special 510(k)s that have been submitted for review has been related to the device modification that is the subject of the submission. As discussed in the Guidance, changes to the intended use and fundamental scientific technology should be submitted as Abbreviated or Traditional 510(k)s rather than as Special 510(k)s. Several of the Special 510(k)s that were submitted included a change to either the intended use or to the fundamental scientific technology.

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Page Last Updated: 10/10/2014
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