[Federal Register Volume 60, Number 199 (Monday, October 16, 1995)]
[Notices]
[Pages 53624-53625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25502]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95D-0283]
Deciding When To Submit a 510(k) for a Change to an Existing
Device; Draft Guidance; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of an August 1, 1995, draft guidance entitled ``Deciding
When to Submit a 510(k) for a Change to an Existing Device.'' The draft
guidance includes a flowchart model that can be used by manufacturers
in their decisionmaking to analyze whether certain changes in a device
could significantly affect the safety or effectiveness of the device
and, therefore, require submission of a new 510(k). The draft guidance
is intended to provide direction to manufacturers, specification
developers, and distributors of devices who intend to modify their
device and are in the process of deciding whether the modification
requires a new premarket notification submission (510(k)).
DATES: Written comments by December 15, 1995.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Deciding When to Submit a 510(k) for a Change to an
Existing Device'' to the Division of Small Manufacturers Assistance,
Center for Devices and Radiological Health (HFZ-220), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597
(outside MD 1-800-638-2041). Send two self-addressed adhesive labels to
assist that office in processing your requests, or FAX your request to
301-443-8818. Submit written comments on the draft guidance to the
Dockets Management Branch (HFA-305), Food and Drug Administration, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857. Requests and comments
should be identified with the docket number found in brackets in the
heading of this document. A copy of the draft guidance and received
comments are available for public examination in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday. Copies of a
facsimile of the draft guidance, are available from the Division of
Small Manufacturers Assistance (DSMA) Facts on Demand, Center for
Devices and Radiological Health (CDRH), 1-800-899-0381. Copies of the
draft guidance may also be obtained from the electronic docket
administered by DSMA and are available to anyone with a video terminal
or personal computer (1-800-252-1366).
FOR FURTHER INFORMATION CONTACT: Harvey Rudolph, Center for Devices and
Radiological Health (HFZ-100), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-2444.
SUPPLEMENTARY INFORMATION:-
I.- Background
On April 8, 1994, FDA circulated for comment the first draft
guidance entitled ``Deciding When to Submit a 510(k) for a Change to an
Existing Device.'' The draft guidance was intended to provide direction
to manufacturers on deciding when to submit a new 510(k) for changes to
an existing device. The April 8, 1994, draft guidance was the subject
of a May 12, 1994, FDA teleconference. The April 8, 1994, draft
guidance was also the subject of discussion at several trade and
industry association meetings.
FDA received over 60 comments regarding the April 8, 1994, draft
guidance. Based on the comments received, FDA developed an August 1,
1995, second draft guidance entitled ``Deciding When to Submit a 510(k)
for a Change to an Existing Device.'' FDA is now announcing the
availability of the August 1, 1995, draft guidance to elicit further
public comment.
II. When to Submit a 510(k) for a Change to an Existing Device
Whenever a manufacturer of a legally marketed device decides to
change the device's design or labeling, it is faced with a decision on
whether to submit a 510(k). Section 807.81(a)(3) (21 CFR 807.81(a)(3))
states that a premarket notification is required for changes to a
currently marketed device that ``could significantly affect the safety
or effectiveness of the device.'' FDA staff have tried to define this
phrase with greater accuracy, as well as the criteria contained in 21
CFR 807.81(a)(3)(i) and (ii) which are expressed in general terms using
adjectives such as ``major'' and ``significant,'' because they can
sometimes lead to subjective interpretation.
FDA's previous attempts to develop guidance in this area have not
been entirely successful, and manufacturers have frequently expressed
the need for more definitive guidance. FDA has now developed such
guidance and is making it available as a draft for public comment.
III. The Draft Guidance
The draft guidance has been developed to provide aid to
manufacturers, specification developers, and distributors of class I,
class II, or preamendment (devices in commercial distribution before
May 28, 1976) class III devices for which premarket approval has not
yet been required under section 515(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e(b)) who intend to modify their device and
are in the process of deciding whether the modification meets the
regulatory threshold for submitting a new 510(k). Whenever possible,
the draft guidance attempts to incorporate existing guidance and policy
regarding when a 510(k) is necessary for modifications to a currently
legally-marketed device.
The draft guidance is not intended to supplant existing definitive
guidance for modifications to specific devices, i.e., for daily wear
contact lenses. Moreover, the draft guidance is not intended to apply
to device kits, nor is it intended to apply to combination products,
such as drug/device or biologic/device combinations. The draft guidance
is also not intended to address the need for submitting a 510(k) by
refurbishers or remanufacturers of devices. FDA intends to develop
additional guidance specific to these situations.
The types of modifications addressed in the draft guidance include
labeling changes, technology or performance specifications changes, and
materials changes. The basis for comparison of any changed device is
the device described by a cleared 510(k) or a legally marketed pre-1976
device. That is, manufacturers may make a number of changes without
having to submit a 510(k), but each time they make a change, the device
they should compare it to is their most recently cleared device or
their pre-1976 device, not the current legally marketed device. In
effect, manufacturers need to submit a new 510(k) only when the sum of
the incremental changes, taken together as though they were in fact one
change, exceeds the Sec. 807.81(a)(3) threshold, ``could significantly
affect the safety or effectiveness of the device.''
According to the draft guidance, because many simultaneous changes
may be considered in the evolution of device design, each type of
change should be assessed separately and, when any one change leads the
manufacturer to decide to submit a 510(k), then a 510(k) incorporating
all
[[Page 53625]]
the current changes and comparing the new device to the originally
cleared device, or one marketed prior to May 28, 1976, should be
submitted. The new 510(k), once cleared, would form the basis of
comparison for the next sequence of changes.
The draft guidance consists of a flowchart model to help
manufacturers through the logic scheme necessary to arrive at a
decision on when to submit a 510(k) for a change to an existing device.
The flowchart includes the following three logical breakouts of changes
that might be made to a device: Labeling changes, technology or
performance specifications changes, and materials changes. To use the
model, the questions posed in the flowchart should be answered until
the 510(k) holder is directed to consider submitting a 510(k), document
the decisionmaking, or notify the agency of the change being effected.
The last option occurs for the addition of a contraindication and the
necessary documentation would constitute an administrative addition to
the 510(k) currently on file.
When contemplating changes to a device, manufacturers should use
the flowchart for each individual type of proposed change, e.g.,
performance specification change, material change, etc. If any one of
the changes results in a manufacturer's decision to submit a 510(k),
then the 510(k) should be submitted and should incorporate all of the
intended changes, as well as a comparison to the originally cleared
device described by the 510(k) currently on file with FDA. If a
manufacturer's consideration of all proposed changes results in a
decision merely to document the decisionmaking, it should document the
application of the model along with the necessary records of the
validation of changes to the device. In those circumstances where the
proposed change is not addressed in the flowchart or in a device-
specific guidance document, manufacturers are encouraged to contact the
Office of Device Evaluation in CDRH to find out whether other, specific
guidance exists or if additional help is available.
IV. Significance of a Guidance
Guidances have generally been issued under Sec. 10.90(b) (21 CFR
10.90(b)), which provides for the use of guidances to state procedures
or standards of general applicability that are not legal requirements,
but that are acceptable to FDA. The agency is now in the process of
revising Sec. 10.90(b). Therefore, the draft guidance is not being
issued under the authority of current Sec. 10.90(b), and it does not
create or confer any rights, privileges, or benefits for or on any
person, nor does it operate to bind FDA or device manufacturers in any
way.
V. Requests for Comments
Interested persons may, on or before December 15, 1995, submit to
the Dockets Management Branch (address above) written comments
regarding the draft guidance. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. The draft guidance and received comments may be seen
in the office above between 9 a.m. and 4 p.m., Monday through Friday.
Received comments will be considered in determining whether to
amend the current draft guidance document.
Dated: October 2, 1995.
Joseph A. Levitt,
Deputy Director for Regulations policy, Center for Devices and
Radiological Health.
[FR Doc. 95-25502 Filed 10-13-95; 8:45 am]
BILLING CODE 4160-01-F