[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Device; Draft Guidance; Availability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availability of an August 1, 1995, draft guidance entitled ``Deciding 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 The draft 
guidance includes a flowchart model that can be used by manufacturers 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 The draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Deciding When to Submit a 510(k) for a Change to an 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 Submit written comments on the draft guidance to the 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 A copy of the draft guidance and received 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facsimile of the draft guidance, are available from the Division of 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