Document issued on: October 22, 1998
U. S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Program Operations Staff
Office of Device Evaluation
Comments and suggestions may be submitted at any time for Agency consideration to the Premarket Notification (510(k)) Section at 10903 New Hampshire Avenue, Silver Spring, MD 20993. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance, contact the Premarket Notification (510(k)) Section at 301-796-5640.
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 2230 to identify the guidance you are requesting.
FREQUENTLY ASKED QUESTIONS ON THE NEW 510(k) PARADIGM
On March 20, 1998, the Center for Devices and Radiological Health (CDRH) announced the availability of a guidance document entitled, "The New 510(k) Paradigm -- Alternatives to Demonstrating Substantial Equivalence in Premarket Notification Submissions. " In this guidance, two new alternatives to the traditional approach of demonstrating substantial equivalence were discussed. Both alternatives, i. e. , the Special 510(k) and the Abbreviated 510(k), were designed to provide flexibility to the device industry, conserve Agency and industry resources, and optimize the contribution of the 510(k) Program to the protection of public health.
Based on the Agency's and industry's experience with the Guidance, the Center has developed the following questions and answers. These should serve to clarify certain aspects of the document, specifically declarations of conformance to design controls and standards, and to promote consistency in the use of the Guidance. This question and answer document1 will be updated on a periodic basis to include frequently asked questions and/or to provide the Agency's perspective on specific issues of the Paradigm. Interested persons can submit questions for inclusion in future revisions by calling the Premarket Notification (510(k)) Section at 301-796-5640.
At the end of this question and answer document, an example of a Special 510(k) for a cardiovascular catheter and a guidance document to be used in preparing an Abbreviated 510(k) for a latex condom can be found. These documents were developed with the aid of the regulated industry to help illustrate the two new alternatives to the Traditional 510(k). Comments on these examples are welcome and may be submitted to the above Internet address.
Are Special and Abbreviated 510(k)s eligible for review under the Agency's Third Party Pilot Program?
Both Special and Abbreviated 510(k)s may be reviewed under the Third Party Pilot Program as long as the 510(k)s are for devices that are included in that program. Given that the Agency has committed to a 30 day review of Special 510(k)s, however, there may be no real advantage to using Third Parties to review this particular type of submission.
Note: Manufacturers should not confuse the review of select 510(k)s by Third Parties with third party involvement in assessing conformance with design controls or standards. This latter topic is discussed in more detail in response to question #4.
Can FDA rely on a declaration of conformity for a substantial equivalence determination in an Abbreviated or Special 510(k) if the manufacturer states that they will conform rather than they are in conformance?
The Food and Drug Administration Modernization Act of 1997 added section 514 (c) Recognition of a Standard to the Federal Food Drug and Cosmetic Act (the act). According to this section of the act, a declaration of conformity to a recognized standard must certify that the device is in conformance. Therefore, in order for the Center 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. The Agency has adopted this same approach for Special 510(k)s. 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 application is submitted.
It should be noted that declarations indicating that a device/firm will conform to a standard/design controls has been the most common reason that a submission has not been accepted for review as either an Abbreviated or Special 510(k), respectively.
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, the Agency 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 design controls or 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 design controls or 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 Agency with additional assurance of conformance. Involvement by an independent, technically competent third party can only benefit the overall process. In The New 510(k) Paradigm, it is stated that if a manufacturer uses a third party to perform a conformance assessment of design control requirements or standards, this information should be maintained in the firm's device master record (DMR). In Attachment 4 of the document, however, it is stated that the declaration to 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. To clarify this issue, the Agency recommends that 510(k) submitters follow Attachment 2 and 4, when preparing declarations of conformity to design controls and standards, respectively. Thus, declarations of conformity to standards should include the name, address, and accreditation of all third parties involved in the conformance assessment. Declarations of conformity to design controls, however, would not need to include this information.
What happens if the Agency determines that a Special or an Abbreviated 510(k) can not be reviewed as such? Is the submission rejected? Is the review clock reset?
If the Agency determines that a Special or 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.
Questions Related to Special 510(k)s
For Special 510(k)s, Attachment 2 of the 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.
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, the Agency will notify the firm ahead of time and follow established GMP inspection procedures.
Having stated the above, manufacturers are reminded 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).
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.
Question Related to Abbreviated 510(k)s
How many standards has FDA recognized? Where can the current list of recognized standards be found?
FDA has recognized approximately 400 standards to which 510(k) submitters can declare conformity. The list of these standards can be found at on the World Wide Web at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. The Agency will update this list on a periodic basis.
Is the 30 day review clock for Special 510(k)s also applicable to Abbreviated 510(k)s?
No. While the Agency expects that declarations of conformity to standards will reduce the review time for Abbreviated 510(k)s compared to Traditional 510(k)s, FDA did not establish 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 Agency.
Having stated the above, the Agency 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 Agency 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 Agency 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?
Section 514 of the act authorizes the Agency to 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.
How long should the records supporting a declaration of conformity to a standard be maintained?
Section 514 of the act requires persons declaring conformity to a standard to 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.
For additional questions and answers on the use of recognized standards in premarket submissions, please see "Frequently Asked Questions on Recognition of Consensus Standards".
Special 510(k): Device Modification
[Date of Submission]
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
Reference : [List Original 510 (k) number, trade name and date of concurrence]
The [Company Name] hereby submits this Special 510(k): Device Modification to request a modification for our Angiographic Catheters. The modification is to change the hub/shaft bonding process and add a 7F catheter line. We believe these modifications are eligible for the Special 510 (k) process since they have the same fundamental scientific technology and intended use as the predicate device.
We consider our intent to market this device as confidential commercial information and requests that it be treated as such by FDA. We have taken precautions to protect the confidentiality of the intend to market these devices. We understand that the submission to the government of false information is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(q).
Thank you in advance for your consideration of our application. If there are any questions, please feel free to contact me at [Phone Number].
[Name of Submitter]
Special 510 (k) - Angiographic Catheter Modification
Table of Contents
Address and Registration Number
Predicate Device Information
Labeling and Intended Use
Device Description and Comparison
Summary of Design Control Activities
Truthful and Accuracy Certification
2. Indications for Use Statement
3. Declaration of Conformity with Design Controls
4. 510(k) Statement
5. Certification of Truthfulness and Accuracy
The device trade names and common/classifications names are:
Device Trade Name
Address and Registration #
The address and registration number of the manufacturer and sterilization sites for both catheters are:
FDA Registration #:
FDA Registration #:
Angiographic catheters have been classified as Class II, 74 HBY. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Angiographic catheters.
Predicate Device Information
The predicate device is the [Trade Name] Angiographic Catheter, [510 (k) Number, concurrence date].
Labeling and Intended Use
Draft labels and Instructions for Use can be found in Attachment 1.
[Make statement that no changes to the labels or Intructions for Use have occurred or identify what changes have been made].
The [Trade Name] Angiographic Catheters intended use are for the delivery of diagnostic agents in the intravascular system. This is the same intended use as previously cleared for the [Trade Name] Angiographic Catheter , [510 (k) Number].
The Indications for Use statement can be found in Attachment 2.
Device Description and Comparison
The device description of the [Trade Name] Angiographic Catheters is as follows.
- 4 - 7 French
- 50 - 150 cm length
- Polyurethane hub insert molded to a braided nylon shaft.
- Maximum burst pressure of 1200 psi
.038" maximum guidewire diameter
The only modifications that were made are:
- Change the hub/shaft bonding process from an adhesive bond to insert molding.
Expand the product line from 4, 5, & 6F to add a 7F version catheter.
[Note: Before and after statements are recommended by FDA to clarify the modifications being made].
The modified angiographic catheters have the following similarities to those which previously received 510(k) concurrence:
- have the same indicated use,
- use the same operating principle,
- incorporate the same basic catheter design,
- incorporate the same materials,
- have the same shelf life, and
are packaged and sterilized using the same materials and processes.
[Note: Listing the similarities is optional, however, it may reduce the need for the reviewer to verify this information in the previous submission].
In summary, the [Trade Name] Angiographic catheters described in this submission are, in our opinion, substantially equivalent to the predicate device.
Summary of Design Control Activities
The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA).2 The design verification tests that were performed as a result of this risk analysis assessment are listed in Table 1 below.
TABLE 1 - Verification Tests
|Change Hub/Shaft Bond Process|
|Addition of 7F Product Line|
The test methods used are the same as those submitted in the original submission.
A declaration of conformity with design controls is included in Attachment 3.
2Manufacturer should list which risk analysis method was used.
A 510(k) Statement for the [Trade Name] Angiographic Catheters is included in Attachment 4.
[Note: This can be replaced by a 510 (k) summary].
Truthful and Accuracy Certification
A certification of the truthfulness and accuracy of the [Trade Name] Angiographic Catheters described in this submission is provided in Attachment 5.
Labels and IFU's
Indications for Use Statement
[Trade Name] Angiographic Catheter
Indications for Use
The [Trade Name] Angiographic Catheter intended use is for the delivery of diagnostic agents in the intravascular system.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801. 109)
Declaration of Conformity with Design Controls
To the best of my knowledge, the verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.
The manufacturing facility, [Company Name] is in conformance with the design control requirements as specified in 21 CFR 820. 30 and the records are available for review.
[NOTE: The above two statements should be signed by the designated individual (s) responsible for those activities].
I certify that, in my capacity as (the position held in company by the person required to submit the premarket notification, preferably the official correspondent), of (company name), I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20. 61.
[Signature of certifier]
Truthful and Accuracy Statement
Pursuant to 21 CFR 807. 87(j), I [Name], certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as [The position held in Company] of [Company Name], and in reliance thereupon, the data and information submitted in this Premarket notification are truthful and accurate and that no facts material for a review of the substantial equivalence of this device have been knowingly omitted from this submission.
1This document is intended to provide guidance. It represents the Agency's current thinking on the above. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.