Determination of Intended Use 
for 510(k) Devices; Guidance for 
CDRH Staff (Update to K98-1) 
 
 
 
Document issued on: December 3, 2002 
 
 
This document supersedes Determination of Intended Use for 510(k) 
Devices; Guidance for Industry and CDRH Staff issued January 30, 1998 
 
 
 
 
 
 
 
 
 
  U.S. Department Of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Office of Device Evaluation 
and 
Office of In Vitro Diagnostic Device Evaluation and Safety 
   
Preface 
 
 
Public Comment 
Comments and suggestions may be submitted at any time for Agency consideration to 
Dockets Management Branch, Division of Management Systems and Policy, Office of 
Human Resources and Management Services, Food and Drug Administration, 5630 
Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.  When submitting 
comments, please refer to Docket No. 98D-0081.  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 
Additional copies are available from the Internet at:  
http://www.fda.gov/cdrh/ode/guidance/857.pdf , or  to receive this document via 
your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone.  Press 1 to enter the system.  At the 
second voice prompt, press 1 to order a document.  Enter the document number 
(857) followed by the pound sign (#).  Follow the remaining voice prompts to 
complete your request.   
 
  Determination of Intended Use for 
510(k) Devices; Guidance for CDRH 
Staff 
 
This document is intended to provide guidance.  It represents the Agencys current 
thinking on this topic.  It does not create or confer any rights for or on any person 
and does not operate to bind the Food and Drug Administration (FDA) or the 
public.  An alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations. 
 
Purpose 
The primary purpose of this guidance document is to reflect the elimination of the sunset 
provision of Section 513(i)(1)(E) of the Federal Food, Drug, and Cosmetic Act (the Act).  
The sunset provision was eliminated by Section 208 of the Medical Device User Fee and 
Modernization Act (MDUFMA) of 2002, permitting Center for Devices and Radiological 
Health (CDRH) staff to continue following established procedures for the determination 
of intended use in 510(k) submissions.   
 
This guidance also updates our procedures to include minor changes we have instituted 
since Section 513(i)(1)(E) was implemented.  Additionally, we have revised the title to 
clarify that these procedures, although they affect industry, are CDRH staff procedures.  
This guidance supersedes Determination of Intended Use for 510(k) Devices; 
Guidance for Industry and CDRH Staff, issued January 30, 1998. 
 
Background 
As stipulated in Section 513(i) of the Act, FDA may issue an order of substantial 
equivalence only upon making the determination that the device to be introduced into 
commercial distribution has the same intended use as the predicate device and is as safe 
and effective as a legally marketed device.  Section 513(i)(1)(E) of the Act generally 
limits the determination of the intended use of a device that is the subject of a premarket 
notification (510(k)) to the proposed labeling contained in the submission.  
 
"Labeling" is defined in Section 201(m) of the Act as "all labels and other written, 
printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) 
accompanying such article." Proposed labels, labeling, and advertisements sufficient to 
describe the device, its intended use, and the directions for use are required to be 
submitted in a 510(k) for review during the substantial equivalence determination. (See 
21 CFR 807.87(e))  
 
Thus, based on the above, the intended use of a device is determined by an evaluation of 
the proposed labeling for the device as submitted in the 510(k).  As stated in ODE Blue 
  1 Book Memorandum #K86-3 entitled Guidance on the Center for Devices and 
Radiological Health's Premarket Notification Review Program (June 30, 1986) 
http://www.fda.gov/cdrh/k863.html, Ordinarily, intended use is determined by reference 
to 'labeling' or promotional claims; only in rare cases might it be necessary to infer 
intended use from other types of information. 
 
In addition to the restrictions regarding the determination of intended use, the law defines 
the procedures to be followed if the Office Director believes that there is a reasonable 
likelihood that the device will be used for an intended use not identified in the proposed 
labeling for the device" and "that such use could cause harm.  (See Section 
513(i)(1)(E)(ii)).  These procedures are described below.   
 
Procedures 
A.  Procedures for Division Staff 
In determining the intended use of a device that is the subject of a 510(k), reviewers 
should continue to follow Blue Book #K86-3 guidance, which states that the intended 
use of the device should be determined by the proposed labeling for the product.  As 
defined above, this includes the actual label for the device and any accompanying 
information such as directions for use and promotional materials. 
 
In reviewing the premarket notification, there may be rare instances in which the 
design of the device or published literature referencing the subject device or a similar 
device, would lead one to believe that there may be an intended use different than that 
appearing in the labeling.  If this situation occurs, the reviewer should bring the 
discrepancy to the attention of senior division management.  
 
The reviewer and division management should consider:  
 
  Whether there is a reasonable likelihood that the device will be used for an 
intended use not identified in the proposed labeling for the device, and 
 
  if such use could cause harm to the patient or the consumer.  
 
If, while reviewing the 510(k), the division makes the determination that there is a 
reasonable likelihood that the device will be used for an intended use other than that 
in the proposed labeling (hereinafter referred to as off-label use) that could cause 
harm, the review of the submission should proceed as follows.  The reviewer should 
discuss all deficiencies with regard to the submission, except those regarding the off-
label use, with the firm and resolve the deficiencies in accordance with established 
division procedures.  Once all other outstanding issues have been resolved, the 
reviewer should promptly bring the concern about the off-label use to the attention of 
the Chief of the Premarket Notification Section (Chief), Program Operations Staff 
(POS).  The Chief will be responsible for coordinating the resolution of the off-label 
use issue with the appropriate Office Director.  If, while reviewing the 510(k), the 
reviewer observes no deficiencies that prevent a substantial equivalence 
  2 recommendation other than the concern regarding an off-label use, the division 
should bring that concern to POS as soon as the review of the 510(k) is complete.  
 
Devices that are substantially equivalent to legally marketed devices that have 
limitations regarding off-label use imposed by the Office Director under Section 
513(i)(1)(E) should be subject to the same limitations.  Review divisions should be 
vigilant in identifying devices that fall within this category.  When a review division 
encounters a device that should be subject to the same limitations regarding off-label 
use as the predicate, the review division should retrieve a copy of the predicate 
devices substantially equivalent (SE) with limitations letter and forward it with the 
submission to POS as described above.1 
 
B.  Procedures for the Office Director 
When the Office Director receives a referral from POS regarding off-label use, the 
Office Director will evaluate the information provided and determine if the two 
statutory criteria are met.  That is, the Office Director must decide (1) if there is a 
reasonable likelihood that the device will be used for an intended use not identified 
in the proposed labeling and (2) if such use could cause harm to the user.2  If the 
Office Director determines that these criteria are not met, the Office Director should 
document the discussion and the Office should promptly issue a substantially 
equivalent (SE) letter.  If, however, the Office Director believes that the two criteria 
are met, the 510(k) submitter will have an opportunity for consultation. 
 
Consultation 
Consultation between the Office Director and the 510(k) submitter may take the form of a 
telephone call or a meeting.  The form of the consultation will depend the needs of both 
parties and the most expedient path to resolution. 
 
Resolution 
Following consultation, one of three actions may ensue.   
                                                 
1 When this situation is encountered, CDRH has determined that the most expedient 
course of action is for POS to send a draft SE with limitations letter to the submitter of 
the pending 510(k).  The letter will propose the identical limitations imposed by the 
Office Director on the predicate device.  The submitter will have an opportunity to assent 
or to request a telephone call or meeting with the Office Director, in accordance with the 
procedures outlined in the Consultation section of this memorandum.  In cases where 
the submitter assents to the proposed limitations, the Office Director will immediately 
issue a final order.   
 
2 For purposes of this document, the term user may be the patient, health care provider, 
or any other person who has the device used on or in himself/herself or who uses the 
device him/herself. 
  3 First after discussing the off-label use issue with the firm, the Office Director may decide 
that the two criteria regarding off-label use have not been met and direct the division to 
issue a substantial equivalence determination.   
 
Alternatively, if the Office Director believes that there is a reasonable likelihood that the 
device will be used for an intended use not identified in the proposed labeling and that 
this use could cause harm, the firm will have an opportunity to:  
 
  modify the device design to address the off-label use; or  
  request a written determination from the Office Director.  
If the modified design satisfies the Agency's concerns regarding the off-label use, the 
division will issue a substantially equivalent determination.   
 
Finally, if the firm either fails to modify the device or decides to request a written 
determination from the Office Director, the Office Director will issue an SE with 
limitations letter within 10 days of the consultation.  
 
The SE letter with limitations letter (the letter) will advise the 510(k) submitter that the 
Office Director has determined that:  
 
  there is a reasonable likelihood that the device will be used for an intended use 
not identified in the proposed labeling for the device; and  
 
  such use could cause harm.   
 
The letter will specify appropriate limitations regarding the off-label use to be included in 
the labeling for the device.  These labeling limitations may be expressed using the 
standardized language provided in the boilerplate letters3 or may include other labeling 
limitations specific to the device and the off-label use, as determined by the Office 
Director.  The letter will require these limitations to be added to the Precautions, 
Warnings, Contraindications, or other appropriate section of the device's labeling.  
Finally, the letter will stipulate that the device is only substantially equivalent if the 
labeling for the device conforms to the limitations specified in the letter.   
 
Special Notes 
As stipulated in Section 513(i)(1)(E) of the Act, the Office Director may not delegate any 
of the responsibilities specified in this memorandum. 
 
According to ODE Blue Book #K97-1 entitled, Deciding When to Submit a 510(k) for a 
Change to an Existing Device http://www.fda.gov/cdrh/ode/510kmod.html, 
manufacturers are permitted to make certain labeling changes without submission of a 
                                                 
3 The boilerplates SE letter with Limitations were drafted for use under the conditions 
described above.  Both Office of Device Evaluation (ODE) and Office of In Vitro 
Diagnostic Devices Evaluation and Safety (OIVDES) SE with Limitations boilerplates, 
K-32 and K-32A, respectively, are available to CDRH staff on the shared drive H:\. 
  4 new 510(k).  The labeling limitations included in the "SE letter with Limitations," 
however, are required by Section 513(i)(1)(E) of the Act.  Therefore, a manufacturer 
must submit a new 510(k) before these limitations are modified in any way or removed 
from the device's labeling.  
  5