The New 510(k) Paradigm Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
Introduction
This document provides guidance to the regulated industry and
reviewers on two alternative approaches that may be used, under
appropriate circumstances, to demonstrate substantial equivalence. It
establishes procedures regarding the use of consensus standards in the
premarket review process (section 514 of the Act, as amended by section
204 of the FDAMA) and reflects other changes to the 510(k) Program that
have resulted from enactment of the new law, such as increased reliance
on postmarket controls to expedite premarket review (section 513 of the
Act, as amended by section 205 of the FDAMA). In addition, it
incorporates concepts that have arisen out of the Center’s
organizational transformation initiative, including a new emphasis on
the use of guidance documents and special controls. The alternative
approaches described in this guidance document should streamline the
510(k) preparation and review processes, thus conserving industry and
Agency resources while still protecting the public health.
Background
Under section 510(k) of the Act, a person who intends to introduce a
device into commercial distribution is required to submit a premarket
notification, or 510(k), to FDA at least 90 days before commercial
distribution is to begin. Section 513(i) of the Act states that FDA may
issue an order of substantial equivalence only upon making a
determination that the device to be introduced into commercial
distribution is as safe and effective as a legally marketed device.
Under 21 CFR 807.87, FDA established the content requirements for
premarket notifications to be submitted by device manufacturers in
support of the substantial equivalence decision. FDA has, however,
discretion in the type of information it deems necessary to meet those
content requirements. For example, to allocate review resources more
effectively to the highest risk devices, FDA developed a tiering system
based on the complexity and the level of risk posed by medical devices.
Under this system, the substantial equivalence determination for low
risk devices is based primarily on descriptive information and a
labeling review, while the decision for higher risk devices relies on
performance data.
In a further effort to manage FDA’s workload and allocate resources
most appropriately, the Agency exempted Class I devices for which it
determined that premarket notification requirements were not necessary
to provide reasonable assurance of safety and effectiveness.
Between the passage of the Medical Device Amendments of 1976 and the
FDAMA, FDA exempted 574 generic types of Class I devices from the
requirement of premarket notification. As a result of the FDAMA, all
Class I devices are exempt from the requirement of premarket
notification, unless the device is intended for a use that is of
substantial importance in preventing impairment to human health or
presents a potential unreasonable risk of illness or injury (“reserved”
criteria). Therefore, only those Class I devices that meet the reserved
criteria remain subject to the premarket notification requirement. (See
63 FR 5387, February 2, 1998, for a listing of Class I “reserved”
devices.)
The FDAMA also gave FDA the authority to directly exempt certain
Class II devices rather than first down-classifying them to Class I
before they become eligible for exemption. On January 21, 1998, FDA
published a listing of Class II devices that no longer require premarket
notification. (See 63 FR 3142.) In the future, additional Class II
devices may become exempt from the premarket notification requirement as
FDA considers additional devices for exemption.
The last phase of the Agency’s effort to evaluate which devices
should be subject to 510(k) review involves the preamendments Class III
devices. Preamendments Class III devices for which general controls or
special controls are sufficient to ensure safety and effectiveness will
eventually be down-classified to either Class I (510(k) exempt or
reserved) or to Class II, respectively. Those preamendments Class III
devices that are not appropriate for reclassification will remain in
that class and be subject to either premarket approval (PMA) or product
development protocol (PDP) requirements. It is anticipated that, as a
result of this reclassification effort, the premarket notification
process will be primarily reserved for Class II devices and a few
“reserved” Class I devices. Until a preamendments Class III device type
becomes subject to a regulation requiring premarket approval, however,
the device type will remain subject to the premarket notification
requirement.
The New 510(k) Paradigm
To streamline the evaluation of premarket notifications for the
reserved Class I devices, Class II devices subject to premarket
notification, and preamendments Class III devices for which FDA has not
yet called for PMAs, the Agency has developed “The New 510(k) Paradigm.”
Attachment 1 outlines the New Paradigm, which presents device
manufacturers with two new optional approaches for obtaining marketing
clearance for devices subject to 510(k) requirements. While the New
Paradigm maintains the traditional method of demonstrating substantial
equivalence under section 510(k) of the Act, it also presents the
“Special 510(k): Device Modification” option, which utilizes certain
aspects of the Quality System Regulation, and the “Abbreviated 510(k)”
option, which relies on the use of guidance documents, special controls,
and recognized standards to facilitate 510(k) review. Use of either
alternative, however, does not affect FDA’s ability to obtain any
information authorized by the statute or regulations.
A. Special 510(k): Device Modification
The Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629)
amended section 520(f) of the Act, providing FDA with the authority to
issue regulations requiring pre-production design controls.
Specifically, section 520(f)(1)(A) states that FDA may prescribe
regulations to require “… that the methods used in, and the facilities
and controls used for, the manufacture, pre-production design validation
(including a process to assess the performance of a device but not
including an evaluation of the safety or effectiveness of a device),
packing, storage, and installation of a device conform to current good
manufacturing practice, as prescribed in such regulations, to assure
that the device will be safe and effective and otherwise in compliance
with this Act.” This change in the law was based on findings that a
significant proportion of device recalls were attributed to faulty
design. Under the authority provided by the SMDA, FDA revised its
current good manufacturing practice requirements to include
pre-production design controls that device manufacturers must follow
when initially designing devices or when making subsequent modifications
to those designs. (See 21 CFR 820.30 Subpart C - Design Controls of the
Quality System Regulation.)
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.
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 21 CFR 820.30. 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 have traditionally been included in 510(k) submissions, the Agency
believes that it may be appropriate to forgo a detailed review of the
underlying data normally required in 510(k)s. 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, the Agency believes that the rigorous design
control procedure requirements produce highly reliable results that can
form, in addition to the other 510(k) content requirements specified in
Attachment 2, 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.
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.
1
Under this option of the Paradigm, a manufacturer who is intending to modify his/her own legally marketed device
2
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. While the basic
content requirements of the 510(k) (21 CFR 807.87) will remain the same,
this type of submission should also reference the cleared 510(k) number
3
and contain a “Declaration of Conformity” with design control
requirements. Refer to Attachment 2 for the contents of a “Special
510(k): Device Modification” with a “Declaration of Conformity” to
design controls.
___________________
1The terms “intended use” and “fundamental scientific
technology” are used in the same manner as when used to define the
limitations of exemptions from section 510(k) of the Act as found in
each of the product classification regulations, 21 CFR 862-892, e.g., 21
CFR §§862.9, 864.9, and 866.9.
2Although not subject to the design control procedure
requirements of the Quality System Regulation, manufacturers of reserved
Class I devices may elect to comply with this provision of the
regulation and submit Special 510(k)s.
3Manufacturers of preamendments devices may submit Special
510(k)s. See footnote 6 of Attachment 2 for information that should be
included in a Special 510(k) under this circumstance.
________________
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
4
to provide a supporting assessment of the conformance. 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 DMR. As always, responsibility
for conformance with design control requirements rests with the
manufacturer.
In order to provide an incentive for manufacturers to choose this
option for obtaining Agency clearance for device modifications, the
Office of Device Evaluation (ODE) intends to process Special 510(k)s
within 30 days of receipt by the Document Mail Center (DMC). The Special
510(k) option will allow the Agency to review modifications that do not
affect the device’s intended use or alter the device’s fundamental
scientific technology within this abbreviated time frame. The Agency
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 application, 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) as
described below.
FDA believes that to ensure the success of the Special 510(k) option
of the Paradigm, there must be a common understanding of the types of
device modifications that may gain marketing clearance by this path. In
this vein, it is critical that industry and Agency staff can easily
determine whether a modification is appropriate for submission as a
Special 510(k). 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.
I. Intended Use
As discussed earlier, modifications to the indications for use of the
device or any labeling change that affects the intended use of the
device should not be submitted 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).
_______________
4 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.
_____________________________
II. Fundamental Scientific Technology
Special 510(k)s should also not be submitted 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:
- A change in a surgical instrument that uses a sharpened metal blade to one that cuts with at a laser;
- A change in an in vitro diagnostic (IVD) device that uses
immunoassay technology to one that uses nucleic acid hybridization or
amplification technology;
- Incorporation of a sensing mechanism in a device to allow the device to function “on demand” rather than continuously.
In addition, the Agency 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 by the Agency. 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:
a. Energy type
b. Environmental specifications
c. Performance specifications
d. Ergonomics of the patient-user interface
e. Dimensional specifications
f. Software or firmware
g. Packaging or expiration dating
h. 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 the National Committee of Clinical Laboratory Standards
(NCCLS) 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.
III. Clinical Considerations
FDA recognizes that clinical evaluation may be involved in the
validation of the design of a modified device. Manufacturers are
reminded that all clinical investigations must conform to the applicable
regulations, including 21 CFR Parts 812, 50 and 56. Therefore,
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, the Agency 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.
B. Abbreviated 510(k)
Over the past few years, FDA has been placing greater emphasis on the
development of guidance documents to communicate regulatory and
scientific expectations to industry. In the 510(k) area, numerous
guidance documents exist, while others are under development for Class
I, Class II and preamendments Class III devices. With the advent of Good
Guidance Practices, device specific guidance documents are developed
with public participation. The main focus of these guidance documents is
the identification of the information recognized as appropriate for
marketing authorization. FDA believes that use of these device-specific
guidances may provide an effective means of streamlining the review of
510(k)s through a reliance on a “summary report” outlining adherence to
relevant guidance documents. A 510(k) submission that conforms with an
FDA guidance document should be easier to prepare and review, thus
resulting in a more expeditious evaluation and clearance of the 510(k).
The SMDA introduced the concept of special controls as a means by
which the safety and effectiveness of Class II devices can be assured.
Special controls are defined in section 513(a)(1)(B) of the 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. As in the case of
guidance documents, summary information that describes how a special
control(s) has been used to address a specific risk or issue should
reduce the time and effort to prepare and review 510(k)s.
In addition to device-specific guidance documents (hereinafter
referred to as guidance documents) and special controls, CDRH is
committed to recognizing individual consensus standards. In fact, the
FDAMA amended section 514 of the Act to specifically authorize the
Agency 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. IEC 60601-1 is an example of
such a consensus standard. It has broad applicability to many
electromedical devices. FDA’s recognition of this standard, combined
with modified review procedures, should streamline the review of many
510(k)s for devices covered by the standard. Finally, by using
accompanying particular standards to adapt a general standard to a
specific device, the 510(k) review process may be further expedited.
Therefore, device manufacturers may choose to submit an Abbreviated
510(k) when: (1) a guidance documents exists, (2) a special control has
been established, or (3) FDA has recognized a relevant consensus
standard.
5 An Abbreviated 510(k) submission must include the
required elements identified in 21 CFR 807.87. In addition,
manufacturers submitting an Abbreviated 510(k) that relies on a guidance
document and/or special control(s) should include a summary report that
describes how the guidance document and/or special control(s) were used
during device development and testing. (See Attachment 3.) The summary
report should include information regarding the manufacturer’s efforts
to conform with the guidance document and/or special control(s) and
should outline any deviations. Persons submitting an Abbreviated 510(k)
that relies on a recognized standard should provide the information
described in Attachment 3 (except for the summary report) and a
declaration of conformity to the recognized standard. (See Attachment
4.) Such persons should also refer to the Agency’s guidance entitled,
“Guidance on the Recognition and Use of Consensus Standards.”
In an Abbreviated 510(k), a manufacturer will also have the option of
using a third party to assess conformance with the recognized standard.
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. Like a Special
510(k), the marketing application should include a declaration of
conformity signed by the manufacturer, while the statement from the
third party should be maintained in the DMR pursuant to the Quality
System Regulation. Responsibility for conformance with the recognized
standard, however, rests with the manufacturer, not the third party.
The incentive for manufacturers to elect to provide summary reports
on the use of guidance documents and/or special controls or declarations
of conformity to recognized standards will be an expedited review of
their submissions. While abbreviated submissions will compete with
traditional 510(k) submissions, it is anticipated that their review will
be more efficient than that of traditional submissions, which tend to
be data intensive. In addition, by allowing ODE reviewers to rely on a
manufacturer’s summary report on the use of a guidance document and/or
special controls and declarations of conformity with recognized
standards, review resources can be directed at more complicated issues
and thus should expedite the process.
_______________
5For a current list of FDA recognized standards, please refer to CDRH’s home page at
http://www.fda.gov/cdrh or CDRH’s Facts on Demand at 1-800-899-0381.
_______________
Conclusion
FDA believes that the New 510(k) Paradigm will provide considerable
flexibility for the medical device industry in demonstrating substantial
equivalence in 510(k) submissions. The principles presented in this
guidance document will be implemented through changes in the
administrative processes and do not require changes to either the
premarket notification regulation (21 CFR 807 Subpart E Premarket
Notification Procedures) or to the Act. As experience is gained by the
industry in preparing Special and Abbreviated 510(k)s and by FDA in
evaluating these new types of 510(k) submissions, this guidance document
may be updated and revised. CDRH will create and update a “New 510(k)
Paradigm” website on the CDRH home page with information regarding this
guidance as it becomes available. Device manufacturers should access
this website for copies of Special/Abbreviated 510(k) coversheets,
checklists, and additional information regarding implementation of the
New Paradigm.
Effective Date: This guidance document is effective March 20, 1998.
____________________________________
_______________________________
Attachment 2
“Special 510(k): Device Modification”
Content
A Special 510(k): Device Modification should include:
- A coversheet clearly identifying the application as a “Special 510(k): Device Modification”;
- The name of the legally marketed (unmodified) device and the 510(k) number under which it was cleared6,7 ;
- Items required under §807.87, including a description of the
modified device and a comparison to the cleared device, the intended use
of the device, and the proposed labeling for the device;
-
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. The declaration of conformity should include:
- 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
-
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.
** The above two statements should be signed by the designated individual(s) responsible for those particular activities.
-
- Indications for Use enclosure.
_____________________________________
6 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.)
7 In cases where the referenced 510(k) was submitted under
a different name than that of the submitter of the Special 510(k), the
Agency 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.
8 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.
_________________________________________
Attachment 3
“Abbreviated 510(k)” Content
An Abbreviated 510(k) should include:
- A coversheet clearly identifying the application as an “Abbreviated 510(k)”;
- Items required under §807.87, including a description of the device,
the intended use of the device, and the proposed labeling for the
device;
- For a submission that relies on a guidance document and/or special
control(s), 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, a declaration
of conformity to the standard. (The declaration should be submitted in
accordance with Attachment 4.);
- Data/information to address issues not covered by guidance documents, special controls, and/or recognized standards; and
- Indications for Use enclosure.
________________________________
Attachment 4
Declaration of Conformity to a Recognized Standard
In preparing a declaration of conformity to recognized
standards, manufacturers should refer to the guidance document entitled,
“Guidance on the Recognition and Use of Consensus Standards.” In
accordance with this guidance, 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 application 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.
___________
(Source:
www.FDA.gov)
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