[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Pages 26786-26790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10888]



Food and Drug Administration

[Docket No. FDA-2013-N-0430]

510(k) Device Modifications: Deciding When To Submit a 510(k) for 
a Change to an Existing Device; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
public meeting entitled ``510(k) Device

[[Page 26787]]

Modifications: Deciding When to Submit a 510(k) for a Change to an 
Existing Device.'' The focus of this meeting is FDA's interpretation of 
its regulations concerning when a modification made to a 510(k)-cleared 
device requires a new 510(k) submission.

DATES: The meeting will be held on June 13, 2013, from 9 a.m. to 5 p.m. 

ADDRESSES: The meeting will be held at FDA's White Oak Campus, 10903 
New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 
1503), Silver Spring, MD 20993-0002. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT:  For technical information: Michael J. 
Ryan, Center for Devices and Radiological Health, Food and Drug 
Administration, 301-796-6283, email: [email protected]. For 
registration questions: Joyce Raines, Center for Devices and 
Radiological Health, Food and Drug Administration, 301-796-5709, email: 
[email protected].
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this meeting must 
register online by 5 p.m. EDT, May 30, 2013. Early registration is 
recommended because facilities are limited and, therefore, FDA may 
limit the number of participants from each organization. If time and 
space permits, onsite registration on the day of the meeting will be 
provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please 
contact Joyce Raines, 301-796-5709 or email: [email protected] 
no later than 5 p.m. EDT, May 30, 2013.
    To register for the meeting, please visit FDA's Medical Devices 
News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select 
this meeting from the posted events list.) Please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, email, and telephone number. Those without 
Internet access should contact Joyce Raines to register (see Contact 
Persons). Registrants will receive confirmation after they have been 
accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Meeting: This meeting will also be 
available via Webcast. Persons interested in viewing the Webcast must 
register online by May 30, 2013, 5 p.m. EDT. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after May 31, 2013. If you have never attended a 
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get 
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site 
addresses in this document, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
    Requests for Oral Presentations: This meeting includes a public 
comment session and topic-focused sessions. During online registration 
you may indicate if you wish to present during a public comment session 
or participate in a specific session, and which topics you wish to 
address. FDA has identified general topics in this document. FDA will 
do its best to accommodate requests to make public comments and 
participate in the focused sessions. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations, and request time for a joint presentation, or submit 
requests for designated representatives to participate in the focused 
sessions. Following the close of registration, FDA will determine the 
amount of time allotted to each presenter and the approximate time each 
oral presentation is to begin, and will select and notify participants 
by June 3, 2013. All requests to make oral presentations must be 
received by the close of registration on May 30, 2013, 5 p.m. EDT. If 
selected for presentation, all of your presentation materials must be 
emailed to Michael Ryan (see Contact Persons) no later than June 6, 
2013. No commercial or promotional material will be permitted to be 
presented or distributed at the meeting.
    Comments: FDA is holding this meeting to obtain information on its 
interpretation of the 510(k) device modifications regulations, and 
specifically, deciding when a 510(k) should be submitted for a change 
to a 510(k)-cleared device. To permit the widest possible opportunity 
to obtain public comment, FDA is soliciting either electronic or 
written comments on all aspects of the meeting topics. FDA would like 
to receive these comments by May 30, 2013, so they can be discussed 
during the meeting; however, comments related to this meeting will be 
accepted until July 13, 2013.
    Regardless of attendance at the meeting, interested persons may 
submit written comments regarding this document to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, or electronic comments to 
http://www.regulations.gov. It is necessary to send only one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II of this document, please identify 
the question you are addressing. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcript: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see Comments). A 
transcript will also be available in either hardcopy or on CD-ROM after 
submission of a Freedom of Information Act request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcript will also be available 
approximately 45 days after the meeting on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this meeting from the posted events list.)


I. Background

    The Food and Drug Administration Safety and Innovation Act (FDASIA) 
became law on July 9, 2012. FDASIA added section 510(n)(2) to the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(n)), 
which requires FDA to withdraw its 2011 draft guidance, ``Deciding When 
to Submit a 510(k) for a Change to an Existing Device,'' and states 
that the 1997 final guidance of the same name shall be in effect until 
FDA issues a guidance or a regulation on the topic. Section 510(n)

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further requires FDA to submit a report not later than 18 months after 
the enactment of FDASIA to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate on when a new 510(k) should be submitted to 
FDA for a modification or change to a legally marketed device. Under 
this provision, the report must address the interpretation of several 
phrases in 21 CFR 807.81(a)(3) (the regulation governing submission of 
510(k)s for changed or modified devices), possible processes for 
industry to use to determine whether a new 510(k) is required, and how 
to leverage existing quality system requirements to reduce premarket 
burden, facilitate continual device improvement, and provide reasonable 
assurance of safety and effectiveness of modified devices. FDA is 
holding this public meeting to solicit input on these issues from all 
interested stakeholders.

II. Topics for Discussion at the Meeting

    FDA invites public input on its interpretation of its regulations 
concerning when a new 510(k) is required for a change to a 510(k)-
cleared device. This input will be used to formulate FDA's report to 
Congress, as well as any future guidance on this topic. FDA would like 
to solicit comments on the following policy options, both in the form 
of submissions to the docket for this Federal Register notice and in 
discussion during the public meeting. Please note that implementation 
of some of these options may require regulatory changes beyond a 
guidance document.

A. Risk Management

    Industry members have proposed use of risk management in the 
decision process on whether a medical device modification requires a 
new 510(k) submission. FDA would like to solicit specific, detailed, 
and practicable proposals that incorporate risk management into this 
decision process in a way that ensures appropriate and consistent 
modification decisions by industry and FDA staff. Appropriate decisions 
in this context are those that allow for both medical device innovation 
and effective FDA oversight of device changes. Consistent results are a 
key consideration, as these decisions must be made by many different 
types of medical device companies and by different FDA review 
divisions. Inconsistent decisions will make policy unclear and 
unpredictable for those making future decisions. Proposals must ensure 
consistency of 510(k) modifications policy, and address and resolve the 
following concerns.
    1. Risk Management is a Process--Published risk management 
standards and guides, such as the International Organization of 
Standardization's (ISO's) 14971:2007, ``Medical devices--Application of 
risk management to medical devices,'' are not designed to produce a 
determination on whether a modified device requires a 510(k). How can 
risk management be tied to a decision on whether a modification 
requires a new 510(k)? More specifically, how can FDA tie risk 
management to the decision that a change or modification in a device is 
one that could significantly affect the safety or effectiveness of the 
device? Provide examples of different devices and how the suggested tie 
between risk management and 510(k) modifications would result in 
consistent decision making.
    2. There are Many Different Ways to do Risk Management--FDA's risk 
analysis process is described in the preamble to 21 CFR part 820, the 
Quality System Regulation, at 61 FR 52620 (October 7, 1996), in the 
response to comment 83. Although FDA's risk analysis process is similar 
to some documented risk management processes, there are many other ways 
to conduct risk management and still meet FDA requirements. Even ISO 
14971, one of the more common risk management guides, allows for 
flexibility in its processes such that different manufacturers 
following ISO 14971 could conceivably reach different risk management 
decisions for similar device changes. How can a single risk management 
process be chosen that leads to consistent and appropriate decisions on 
whether a 510(k) is required for a device modification?
    3. Risk Management Analyses Inherently Involve Subjectivity--Risk 
management requires the manufacturer to: (1) Establish ``criteria for 
risk acceptability, based on the manufacturer's policy for determining 
acceptable risk,'' (2) predict known and foreseeable hazards associated 
with the device, (3) estimate the risks for each hazard, and (4) 
evaluate the risks of each associated hazard using the manufacturer's 
established criteria. ISO 14971. FDA is not aware of universally 
accepted risk acceptability criteria for medical devices. Furthermore, 
it is often difficult to find objective data to help determine 
frequency and even severity of risk, which often leads to inconsistent 
risk analyses. How can the inherent subjectivity of risk management be 
controlled to ensure consistent and appropriate decisions on whether a 
510(k) is required for a device modification?
    4. A Company's Risk Management Processes are Contained Within its 
Overall Quality System and May Not be Specifically Scrutinized by FDA 
During 510(k) Reviews--To consider integration of risk management in 
the 510(k) modification decision-making process, FDA must have 
assurance that a company's risk management process is comprehensive and 
appropriately implemented. How can FDA obtain such assurance?

B. Reliance on Design Control Activities

    FDA is soliciting proposals for how industry and FDA could utilize 
design control activities such as design verification and validation to 
ensure that device modifications are appropriately evaluated prior to 
marketing. FDA would need some form of effective oversight in this 
process to properly perform its function of protecting the public 
health. The Agency would need the opportunity to review design control 
activities when necessary because improper application of these 
activities may lead to incomplete or inaccurate evaluations of design 
changes and the marketing of unsafe or ineffective devices. At this 
time, FDA generally reviews design control information for 510(k)-
eligible devices only during inspections, and inspections do not 
necessarily focus on the specific information (such as design 
specifications, testing protocols, etc.) that FDA needs to review to 
ensure that design changes are properly evaluated. Inspection resources 
are also limited. Any proposal for reliance on design control 
activities as part of FDA's 510(k) modifications policy should consider 
how FDA may ensure effective oversight. Input on the following specific 
questions is requested.
    1. FDA Does Not Typically Review Design Control Information Prior 
to Marketing Clearance and Resource Issues, Among Other Things, Limit 
the Extent of its Review of Design Control Information--How can FDA 
ensure that design control activities will limit the potential for 
marketing of device modifications that may be unsafe or ineffective?
    2. Although 21 CFR 820.30 Imposes the Same Design Control 
Requirements on All Medical Device Manufacturers, the Ways in Which 
Manufacturers Comply with These Requirements Vary--How can FDA ensure 
consistency in use of design controls to ensure that only safe and 
effective modified devices are marketed?

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C. Critical Specifications

    Industry members have proposed the use of critical specifications, 
a new concept, to make decisions on whether a 510(k) is required for a 
device modification easier. This concept would be one way that FDA 
could link use of design control activities to 510(k) modification 
    Under this proposal, if FDA and manufacturers can identify 
essential device specifications--critical specifications--and can agree 
on limits and testing protocols for those specifications within a 
510(k), then a device manufacturer may make modifications to a device, 
and as long as the resulting device remains within the agreed-upon 
limits for all of the critical specifications, no new 510(k) would be 
required for that modified device. This approach could allow FDA to 
rely on the quality system regulation to ensure that qualifying changes 
could not significantly affect safety and effectiveness because there 
was no change to a critical specification. FDA would like to discuss 
the feasibility of this approach, both for manufacturers and FDA's 
review staff, and how it might be implemented. It is important to note 
that this approach would not apply to changes to intended use or 
labeling, as those aspects of a device are not associated with 
    Critical specifications could include a range of technological and 
material design aspects, such as dimensional specifications, shelf 
life, or material purity. Critical specifications would necessarily be 
device specific, so it would be impossible to identify all of the 
possible specifications in guidance, although FDA guidance could note 
useful examples. To qualify as a critical specification, FDA and the 
510(k) submitter would have to agree on the identity and parameters of 
a critical specification within a 510(k) review. The manufacturer would 
have to clearly identify types of changes that might be made, which 
specifications it would designate as critical for those types of 
changes, and specification bounds or tolerances. For example, if a 
manufacturer anticipates possible changes in materials for an implant 
(e.g., due to supplier changes that may occur post-clearance), then it 
might wish to designate tensile strength of the material as a critical 
specification. It would then set parameters for properties that the new 
material needs to meet; for instance, tensile strength must be 950 MPa 
 15 MPa (megapascals). The 510(k) would also describe how 
tensile strength would be tested. FDA reviewers would need to consider 
whether any other properties should be identified as critical 
specifications for the type of change in question, and whether 
appropriate test methods have been identified to ensure the modified 
device will meet its critical specifications. Voluntary consensus 
standards (such as those recognized on FDA's Web site in its recognized 
standards database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) could be used to determine critical 
specifications and their parameters or testing protocols. If critical 
specifications are agreed on prior to 510(k) clearance, then a 
manufacturer who modifies its device after clearance would be able to 
do so without submission of a new 510(k) as long as the agreed-upon 
verification and validation activities show those critical 
specifications are unchanged.
    To take advantage of this approach, manufacturers would have to 
identify the following in their 510(k) submissions:
     A list of potential changes that might be made;
     Critical specifications for each change: Those device 
specifications--physical, material, or performance--that are essential 
to safe and effective use of the device (e.g., tensile strength);
     Bounds for those specifications that a changed device must 
remain within (e.g., 950 MPa  15 MPa); and
     The verification and validation test protocols that will 
be used to examine those specifications pre- and post-modification, 
within the rubric of the quality system regulation.
    FDA's review staff would be responsible for reviewing the above 
information and determining whether a change that results in a device 
that remains within the identified specifications could significantly 
affect safety or effectiveness.
    FDA is soliciting input on the feasibility of the critical 
specifications approach and proposals for how FDA could implement such 
a program. Input on the following specific questions is requested.
    1. How could critical specifications be incorporated into FDA's 
review process? Review of critical specifications proposals in 510(k)s 
will require additional review time and resources. How should 
situations where agreement cannot be reached within review timeframes 
be handled? How could situations where FDA is ready to proceed with a 
substantial equivalence decision, but critical specifications have not 
been agreed upon, be handled?
    2. How could critical specifications agreements be documented? 
Should they be summarized in 510(k) Summaries or substantial 
equivalence letters?
    3. Should use of critical specifications be limited to certain 
types of changes? If so, which ones?
    4. Are there particular specifications that could be deemed 
critical for all devices? If so, which ones?
    5. Could critical specifications be implemented as an optional 
paradigm? This approach could potentially be implemented as an optional 
approach that manufacturers could use where it is most efficient; 
manufacturers that chose not to identify critical specifications in a 
510(k) would then be subject to the current 510(k) modifications 
decision-making paradigm. Please discuss the practical implications of 
this approach.

D. Risk-Based Stratification of Medical Devices for 510(k) 
Modifications Purposes

    FDA is seeking comments on the practicality of stratifying device 
types that require 510(k)s by risk. Under such a framework, FDA would 
expect 510(k)s for modifications of higher risk devices that meet the 
standard in 21 CFR 807.81(a)(3). For lower risk devices, FDA would not 
expect 510(k)s for all modifications that meet the standard in 
807.81(a)(3). However, because modifications to lower risk devices 
could still result in harm or injury, FDA would expect 510(k)s for 
certain modifications (for example, changes to the indications for use) 
even if the device is lower risk. FDA could require some other measure, 
such as periodic reporting, for modifications of lower risk devices 
that are not submitted in 510(k)s. This approach would allow FDA to 
focus review resources on areas that are more important from a public 
health perspective. Comments on this approach should address the 
following questions.
    1. How should FDA delineate higher versus lower risk devices? For 
example, would higher risk devices include only those designated as 
life sustaining, life supporting, or implants?
    2. Should FDA require some other measure, such as periodic reports, 
for modified lower risk devices in lieu of 510(k) submissions?
    3. Because modifications to lower risk devices could still result 
in harm or injury, FDA believes that some modifications to lower risk 
devices should still be reviewed in 510(k) submissions prior to 
marketing. How should FDA delineate which lower risk device 
modifications require 510(k)s and which do not?

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E. Periodic Reporting

    FDA is soliciting comments on the advisability of requiring 
periodic reporting for modifications to 510(k)-cleared devices that do 
not require new 510(k) submissions. FDA does not typically review 
510(k) modifications decisions that do not result in 510(k) 
submissions, unless that information is specifically looked at during 
an inspection or submitted in conjunction with future changes that do 
require a 510(k). If manufacturers were required to submit periodic 
reports identifying and describing their design changes that did not 
result in 510(k) submissions, FDA would then review these changes and 
ensure that decisions were made appropriately. This process would 
likely be similar to annual reporting of device changes for approved 
class III devices. Over time, periodic reporting would give FDA a more 
complete picture of the changes industry is making to 510(k)-cleared 
devices, and may allow FDA to tailor 510(k) modifications requirements 
to ensure that the Agency is reviewing only the changes it needs to in 
new 510(k) submissions. Review of periodic reports, however, would 
require additional FDA resources. Comments on periodic reporting should 
address the following questions.
    1. How often should FDA require periodic reports, e.g., annually, 
biannually, etc.?
    2. Should FDA require periodic reports for all 510(k) devices or 
only certain devices? If not all devices, then which ones?
    3. What information should be included in a periodic report?

F. Other Policy Proposals

    FDA acknowledges that any one of the above options may be 
insufficient on its own; if any changes are made to FDA's 510(k) 
modification policy, the Agency may adopt a combination of those 
options. FDA also acknowledges that other options may exist that have 
not been identified above. FDA is therefore soliciting any other 
proposals for revising the Agency's 510(k) modification policy. Any 
policy must ensure:
     Consistent decision-making by both industry and FDA;
     Adequate control of device modifications that could 
significantly affect safety or effectiveness; and
     Effective FDA oversight of modifications to 510(k)-cleared 
devices to adequately protect the public health and allow for medical 
device innovation.

Proposals should be as detailed and specific as possible, and should 
take into account the issues discussed above in the individual options.

G. Examples

    In addition to the options discussed above, FDA is seeking specific 
examples of device changes that manufacturers have made that should not 
trigger the requirement for a new 510(k) submission, with explanations 
as to why 510(k) submissions should not be required. These examples 
will help FDA develop an appropriate 510(k) modifications policy. FDA 
typically sees only those device modifications that result in new 
510(k) submissions; device changes that do not result in new 510(k) 
submissions generally are not reviewed by the Agency. Industry 
provision of these changes will help inform FDA's 510(k) modifications 
    Examples of device changes may also be used for discussion during 
this public meeting. All examples discussed publicly will be de-
identified. Examples may be submitted to the Agency in de-identified 
form through third parties such as trade associations.

    Dated: May 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10888 Filed 5-7-13; 8:45 am]