Contains Nonbinding Recommendations
Custom Device Exemption
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on September 24, 2014.
The draft of this document was issued on January 14, 2014.
For questions about this document, contact Office of Regulatory Programs, Division of 
Regulatory Programs 1 (Submission Support) at 301-796-5640 or customdevices@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
OMB Control No. 0910-0767
Current expiration date available at https://www.reginfo.gov.
See additional PRA statement in Section VIII of this guidance. Contains Nonbinding Recommendations 
Preface 
 
Public Comment  
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management, Food and Drug Administration, 5630 Fishers Lane, Rm 1061, (HFA-305), 
Rockville, MD 20852. Identify all comments with the docket number FDA-2013-D-1601. 
Comments may not be acted upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document 
number 1820 to identify the guidance you are requesting. 
  Contains Nonbinding Recommendations 
Table of Contents
 
 
I.  Introduction ................................................................................................................................................ 1 
II.  Background ................................................................................................................................................ 1 
III.  Definitions ................................................................................................................................................. 2 
IV.  No More Than Five Units Per Year of a Device Type ............................................................................... 3 
V.  Questions and Answers/Examples of Custom Devices .............................................................................. 5 
A.  From which  premarket and postmarket requirements is my custom device exempt ? ............................. 5 
B.  The custom device exemption describes two types of custom devices: one specific to the special needs 
of the physicians practice, and the other specific to the patients unique physiological/pathology needs. Can 
a single custom device be unique both to a physicians practice and the patients unique needs? ..................... 5 
C.  Can a device subject to an IDE be a custom device?................................................................................. 5 
D.  What is the relationship between compassionate use and a custom device? ............................................. 5 
E.  Can modifications to an existing 510(k)-cleared device be made under the custom device exemption? .. 6 
F.  How are revisions and servicing of existing valid custom devices included in the total of five units of a 
device type per year? .......................................................................................................................................... 7 
G.  If a patient needs to undergo revision surgery to replace a component of her implant that is no longer 
being manufactured, is the component a custom device? ................................................................................... 7 
H.  Are pediatric devices automatically custom devices, simply because they are for a pediatric population?
  7 
I.  How should I label my custom device? ..................................................................................................... 7 
J.  Can I market my custom device to the general public? ............................................................................. 8 
K.  What are some examples of devices that are potential custom devices? ................................................... 8 
L.  What are some examples of a device that is not a custom device? ............................................................ 9 
VI.  Annual Report ............................................................................................................................................ 9 
A.  Annual Report  General Contents .......................................................................................................... 10 
1.  Cover Letter ...................................................................................................................................... 10 
2.  Truthful and Accurate Statement.................................................................................................... 10 
3.  Other Logistical Information ........................................................................................................... 10 
B.  Annual Report  Patient-Centric Custom Device Information ................................................................ 11 
1.  Explanation of how the device satisfies the elements of Section 520(b) of the FD&C Act. ......... 11 
2.  Summary of Custom Devices Shipped, Used, Returned, and Destroyed ..................................... 12 
3.  Details on Custom Device Use .......................................................................................................... 13 
C.  Annual Report  Physician-Centric Custom Device Information ........................................................... 13 
1.  Explanation of how the device satisfies the elements of Section 520(b) of the FD&C Act .......... 13 
2.  Accommodating a Physicians Special Need ................................................................................... 14 
3.  Details on Custom Device Use .......................................................................................................... 15 
b)  Custom device or custom device components. You should provide information on the number of 
custom devices or custom device components that were shipped, sold, and returned or destroyed by the 
ordering physician during the reporting period. This includes the date of manufacture, the product name, 
brand name, product model number, product catalog number, or other product identifier information, and 
product code (if applicable). ......................................................................................................................... 15 
D.  FDAs Review of Your Annual Report ................................................................................................... 15  Contains Nonbinding Recommendations 
VII.  Complete Text of Section 520(b) of the Food, Drug and Cosmetic Act .................................................. 15 
Please see Appendix III for a flow diagram of the decision tree needed to implement the custom device 
provisions in the FD&C Act. ................................................................................................................................ 16 
VIII. Paperwork Reduction Act of 1995............................................................................................................... 16 
Appendix I ............................................................................................................................................................ 18 
Appendix II........................................................................................................................................................... 20 
Custom Device Annual Report Truthful And Accurate Statement ............................................................... 20 
Appendix III ......................................................................................................................................................... 21  Contains Nonbinding Recommendations 
Custom Device Exemption  
 
Guidance for Industry and  
Food and Drug Administration Staff  
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking 
on this topic. It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations. If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance. If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance.  
I.  Introduction 
The Food and Drug Administration (FDA) has developed this document to provide guidance 
to industry and FDA staff about implementation of the custom device exemption contained in 
Section 520(b) of the Food, Drug and Cosmetic Act (FD&C Act).  The guidance provides 
definitions of terms used in the custom device exemption, explains how FDA interprets the 
5 units per year of a particular device type language contained in section 520(b)(2)(B) of 
the FD&C Act, describes what information should be submitted in a Custom Device Annual 
Report (annual report), and provides recommendations on how to submit an annual report 
for devices distributed under the custom device exemption.  
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited. The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.  
II.  Background  
Effective July 9, 2012, section 617 of the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Pub. L. 112-144) required the implementation of changes to the 
custom device exemption contained in section 520(b) of the FD&C Act. The new provision 
amended an existing custom device exemption and introduced new concepts and procedures 
applicable to custom devices addressing, among other things: 
 
  1  Contains Nonbinding Recommendations 
  devices created or modified in order to comply with the order of an individual 
physician or dentist;1  
  the potential for multiple units of a device type (not to exceed 5 units per year) 
qualifying for the custom device exemption; and 
  annual reporting requirements by the manufacturer to FDA about devices 
manufactured and distributed under section 520(b) of the FD&C Act. 
 
Although the revisions to the custom device exemption clarify the availability of the 
exemption in certain circumstancesfor example, when more than one (but not greater than 
five) devices are manufactured per year and when modifications are made to a marketed 
devicethe new statutory language does not create a broad, new exemption from sections 
514 and 515 of the FD&C Act. Under the revised provision, as under the original custom 
device exemption, custom devices should represent a narrow category for which, due to the 
rarity of a patients medical condition or physicians special need, compliance with 
premarket review requirements and performance standards under sections 514 and 515 of the 
FD&C Act is impractical.  
 
Historically, practitioners and manufacturers have sought custom device exemptions for 
devices more properly considered under a compassionate use protocol.  FDA notes that some 
devices deemed ineligible for custom devices status prior to FDASIA would remain 
ineligible under the new provision, but may qualify for compassionate use. Although a full 
discussion of compassionate use is outside the scope of this guidance, a short discussion of 
compassionate use is included in the Question and Answer section of this guidance. 
III.  Definitions
 
Device Type  
A generic device type is defined as a grouping of devices that do not differ significantly 
in purpose, design, materials, energy source, function, or any other feature related to 
safety and effectiveness, and for which similar regulatory controls are sufficient to 
provide reasonable assurance of safety and effectiveness.2 
  
Importer  
Importer means any person who imports a device into the United States.3  
 
Necessarily Deviates 
Necessarily deviates means that a device should be sufficiently unique so that clinical 
investigations would be impractical and could not be performed to demonstrate conformance 
to applicable performance standards and/or support premarket review.4 
 
                                                           
1 For the readability of this document, the word physician is defined to represent physician or dentist (or any 
other specially qualified person designated under regulations promulgated by the Secretary). Section 
520(b)(2)(A) of the FD&C Act. 
2 See 21 CFR 860.3(i). 
3 See, e.g., 21 CFR 806.2(f). 
4 48 FR 248 Pages 56778, 56796, December 23, 1983.  
  2  Contains Nonbinding Recommendations 
Not Generally Available 
A device that is not generally available is a device not generally available in finished form 
through labeling or advertising by the manufacturer, importer, or distributor for manufacture 
and/or commercial distribution in the United States and is of a type available for introduction 
into commercial distribution in quantities of no more than five units per year. This includes, 
but is not limited to, devices not addressed in electronic or hard copy literature, promotional 
material, or available testimonials. For example, a manufacturer could make a custom device 
in response to an unsolicited request by a physician who specifies unique design inputs when 
no similar product is commercially available in the United States and clinical investigations 
on such device would be impractical. 
 
Order of a Physician  
Order of a physician refers to the written request for a custom device made by a physician. 
In the case of a prescription device, this would include the written or electronic prescription. 
 
Special Need 
A special need is a need related to an individual physicians unique pathology or unique 
physiological condition. 
 
Sufficiently Rare Condition 
A sufficiently rare condition is a condition in a patient population in which the incidence or 
prevalence is so small that conducting clinical investigations on a device to treat it would be 
impractical.  
 
Unique Pathology 
Unique pathology is pathological anatomy that no other device is domestically available to 
treat.  
 
Unique Physiologic Condition 
A unique physiologic condition is a physiologic condition that no other device is 
domestically available to treat.  
IV.  No More Than Five Units Per Year of a Device Type
 
Under FDASIA, devices that qualify for the custom device exemption contained in section 
520(b) of the FD&C Act are limited to no more than 5 units per year of a particular device 
type that otherwise meet all the requirements necessary to qualify for the custom device 
exemption.  
 
FDA has applied the definition of device type to take into account multiple considerations 
such as anatomical location, disease state, material, technology, and indications. For 
example, knee replacement device systems comprise multiple device types; although used in 
the same anatomical location, knee systems with different technological characteristics 
(including materials) or used in different disease states can constitute different types of knee 
systems.  
 
  3  Contains Nonbinding Recommendations 
FDA interprets the five units in terms of five new custom device cases per year (i.e., five new 
patients for the patient-focused custom device or five new physicians for the physician-
focused custom device, assuming all other required elements for the custom device 
exemption are satisfied). The five-unit limitation includes all devices of a type provided by a 
manufacturer to, and remaining in the possession of, the ordering physician and/or the 
patient.  
 
FDA does not intend to include in the tally of five units per year any extra units produced for 
a unique case because of sizing concerns, so long as the ordering physician has either 
destroyed those devices not used for that case or they have been returned to the manufacturer 
and not redistributed without valid U.S. marketing authorization or for a subsequent valid 
custom device case. FDA expects the manufacturer to use appropriate quality system 
procedures to control returned product and ensure they are only redistributed under 
appropriate circumstance (i.e., another valid custom device case or U.S. marketing 
authorization). For example, if four sizes of a valid custom orthopedic implant are 
manufactured for a specific patient and one device is ultimately implanted into the patient, 
then the remaining three sizes should either be returned to the manufacturer or destroyed by 
the ordering physician. If these units are not returned to either the manufacturer or the 
ordering physician does not provide the manufacturer a statement of destruction, then FDA 
considers four of the five total units per year of that device type to have been used. On the 
other hand, if the three other units are returned to the manufacturer or the ordering physician 
provides the manufacturer a statement of destruction, only one of the five units per year will 
have been used to treat this patient, provided the returned devices are not redistributed 
without valid U.S. marketing authorization or for use in a subsequent valid custom device 
case. 
 
The devices used in the case where a patient requires multiple devices of the same type (such 
as bilateral conditions) to treat multiple anatomical locations within a given reporting year 
will be considered one unit for purposes of tallying the five units of a device type per year, so 
long as those devices are ordered together and the ordering physician either destroys any 
unused devices or those devices are returned to the manufacturer and not redistributed 
without valid U.S. marketing authorization or used in a subsequent valid custom device case. 
For example, in the event that a patient requires valid custom bilateral joint replacement 
devices (such as might occur in bilateral knee replacement procedures), so long as those 
devices are ordered together in the same reporting year, and the ordering physician provides 
the manufacturer with either a statement of destruction or returns all unused product to the 
manufacturer, FDA will consider the multiple joint replacement devices needed to treat the 
bilateral patient as only one of the five allotted units per year of a device type. If the patients 
multiple replacement devices are ordered during different reporting years, each treatment will 
contribute one unit to the tally for the reporting year in which the ordering occurs (so long as 
the ordering physician provides the manufacture a statement of destruction for the unused 
devices or returns them to the manufacturer, and the manufacturer does not redistribute 
without either a valid U.S. marketing authorization or for use in a subsequent valid custom 
device case). 
  4  Contains Nonbinding Recommendations 
V.  Questions and Answers/Examples of Custom Devices 
A.  From which  premarket and postmarket requirements is my custom device 
exempt ?  
Under Section 520(b) of the FD&C Act, custom devices are exempt from Premarket 
Approval (PMA) requirements and conformance to mandatory performance 
standards. 5 Custom Devices are not exempt from any other requirements, including, 
but not limited to, the Quality System Regulation, including Design Controls (21 CFR 
Part 820); Medical Device Reporting (21 CFR Part 803); Labeling (21 CFR Part 
801); Corrections and Removals (21 CFR Part 806); and Registration and Listing (21 
CFR Part 807). 
B.  The custom device exemption describes two types of custom devices: one 
specific to the special needs of the physicians practice, and the other 
specific to the patients unique physiological/pathology needs. Can a single 
custom device be unique both to a physicians practice and the patients 
unique needs?  
No, the custom device provision allows for development of two different categories 
of custom devices. One is patient-centric, and the other physician-centric; a custom 
device cannot be both patient- and physician-centric. A custom device made to treat a 
patients sufficiently rare condition leaves a medical practice with the patient, while a 
custom device made to satisfy a physicians unique special need remains with that 
physician for use in his/her practice.  
C.  Can a device subject to an IDE be a custom device?  
No, a device that is currently being studied or capable of study under an IDE does not 
meet the definition of a custom device. Additionally, the IDE is a broad exemption 
under which devices used in clinical investigations that meet IDE requirements are 
exempt from FD&C Act sections 514, 515, 502, 510, 516, 519, 510(e), 520(f) and 
721. There is no reason to seek a custom device exemption for a device capable of 
study under an IDE, because custom devices represent a narrow category of devices 
used to treat sufficiently rare conditions or rare physician needs for which clinical 
investigations cannot be practicably conducted.  
D.  What is the relationship between compassionate use and a custom device?  
Devices that do not meet all elements of the custom device definition described in 
section 520(b) of the FD&C Act may qualify, under appropriate circumstances, for 
compassionate use. An unapproved and uncleared medical device may be used on 
human subjects when its use is under clinical investigation and complies with all 
                                                           
5 A device not covered by an existing marketing approval would require either a PMA or a valid exemption 
from the requirements to obtain PMA approval in order to be introduced into interstate commerce. Examples of 
potential valid exemptions or alternatives from the PMA requirement include: (1) establishing the substantial 
equivalence of the new device to a valid predicate device, (2) approval of an Investigational Device Exemption 
(IDE) or (3) meeting all custom device exemption requirements.  
  5  Contains Nonbinding Recommendations 
applicable requirements.6 FDA recognizes there may be limited circumstances under 
which a health care provider may seek to use an unapproved and uncleared device to 
treat a patient suffering from a serious disease or condition for which no alternative 
therapy exists. FDA provides more information on how to request compassionate use 
of an unapproved device in the guidance document Guidance on IDE Policies and 
Procedures 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/ucm080202.htm). 
 
Compassionate use of an unapproved and uncleared device may occur when a device 
is the only option available to a patient with a serious condition. All compassionate 
uses require, among other things, prior FDA approval. See Section 561(b) of the 
FD&C Act and 21 CFR 812.35(a). Please refer to the guidance listed above for more 
information on compassionate use of unapproved devices. 
E.  Can modifications to an existing 510(k)-cleared device be made under the 
custom device exemption?  
Modifications to a 510(k)-cleared device that maintain its original intended use and 
could be clinically studied do not appropriately qualify as a custom device and should 
be handled in accordance with 21 CFR 807.81 and the guidance document Deciding 
When to Submit a 510(k) for a Change to an Existing Device (K97-1) 
(http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocument
s/ucm080235.htm) (i.e., submission of a new 510(k) application, or documentation to 
the design history file explaining why the change does not require a new 510(k), as 
appropriate). However, if an existing 510(k)-cleared device is modified to treat a 
unique pathology or unique physiological condition, which renders clinical study 
impractical, the device could potentially qualify as a custom device.  
 
It is worth noting that FDA reviews, clears, and approves for marketing many patient-
specific devices (also referred to as patient-matched devices). Patient-specific devices 
are, in general, ones in which ranges of different specifications have been approved or 
cleared to treat patient populations that can be studied clinically. Premarket 
submissions for such devices are sometimes referred to as envelope submissions 
because their approval or clearance covers the entire range of specifications data they 
contain to support. The final manufacturing of these devices can be delayed until 
physicians provide imaging data or other information to the manufacturer to finalize 
device specifications within cleared or approved ranges. As a result, such devices are 
specifically tailored to patients.7 For example, a manufacturer of an ankle 
replacement device could submit a 510(k) to cover a range of specifications for 
                                                           
6 See Section 520(g) of the FD&C Act and 21 CFR Parts 50, 56, and 812, Investigational Device Exemptions 
(IDE), includes requirements for the conduct of clinical studies on human subjects with medical devices, such 
as the content of the IDE application, responsibilities of sponsors and investigators, labeling, recordkeeping, and 
reporting to FDA. 
7 CDRH has received 510(k)s and PMA applications for patient-specific/patient-matched medical devices in a 
number of different product areas including but not limited to TMJ implants, dental abutments, orthopedic 
surgical cutting guides, orthopedic joint replacement implants, and trauma and dental bone plates. 
  6  Contains Nonbinding Recommendations 
different system components to accommodate multiple patients with different 
anatomical characteristics. While some in industry have sometimes colloquially 
referred to these devices as customized, they are not custom devices meeting the 
FD&C Act custom device exemption requirements unless they comply with all of the 
criteria of section 520(b). Marketing applications are required for these device types 
because the devices and patient populations can be defined and studied. 
F.  How are revisions and servicing of existing valid custom devices included in 
the total of five units of a device type per year? 
A device that meets all requirements of section 520(b) of the FD&C Act when 
initially distributed will not be counted against the five device units per year 
allotment if it has later been revised or serviced, provided that such revision or 
servicing is performed in furtherance of meeting the special needs of the person or 
physician for whom the custom device was intended before being revised and/or 
serviced. If you have any questions, you can contact CDRHs Office of Compliance 
to discuss the specifics of your situation prior to revising or servicing such device. 
G.  If a patient needs to undergo revision surgery to replace a component of her 
implant that is no longer being manufactured, is the component a custom 
device? 
The component is only a custom device if it is designed to treat a unique pathology or 
physiological condition that no other device is domestically available to treat and 
meets all the other requirements of section 520(b). That the component is no longer 
being manufactured does not make the component a custom device. However, under 
these circumstances, a compassionate use request to allow the component to be 
manufactured and implanted could be submitted to FDA. 
H.  Are pediatric devices automatically custom devices, simply because they are 
for a pediatric population?  
No. Pediatric patient populations may be studied just like adult populations, and, to 
the extent possible, they should be studied so that a device can be  labeled properly. 
The proper labeling of a device can provide users a better understanding of the 
devices performance characteristics.  
I.  How should I label my custom device? 
Custom devices remain subject to all device labeling requirements, among them 
requirements that the labeling bear adequate directions for use or may not be false or 
misleading, as well as many other labeling requirements, including those in 21 CFR 
801.1. In addition, the labeling accompanying a custom device should include the 
following information: (1) a statement that the device is a custom device; (2) the 
name of the ordering physician, (3) identifying information for the patient (if 
applicable) whom the device is intended to treat; (4) indications for use; (5) 
  7  Contains Nonbinding Recommendations 
sterilization status; (6) relevant composition information (materials, components, 
etc.); and (7) storage conditions.8  
J.  Can I market my custom device to the general public? 
No. A custom device is made at a physicians order on patients with a sufficiently 
rare condition or for a physicians special needs (e.g., unique pathology or unique 
physiologic condition). Section 520(b)(1)(C) specifies that, among other things, a 
custom device is not made generally available in finished form through labeling or 
advertising.  
K.  What are some examples of devices that are potential custom devices?9 
A possible example of a custom device might be one manufactured for a patient with 
skeletal dysplasia requiring a total hip replacement procedure to treat her 
osteoarthritis. The patients skeletal dysplasia could be characterized by abnormalities 
in the growth and/or remodeling of cartilage and bone, resulting in short stature and 
angular and torsional deformities of the patients hip. In this particular case, it is 
possible that currently available total hip replacement devices marketed in the United 
States might not successfully treat the patients unique pathological anatomy. Other 
elements of the custom device exemptionfor example, too small a patient 
population to support a clinical studywould need to be met. 
 
Another possible example of a custom device might be an artificial cervical disc 
replacement for reconstruction of the cervical disc following cervical discectomy to 
treat cervical radiculopathy in a 72 male patient. Under this hypothetical scenario, 
the osseous dimensions of this patient's cervical spine exceed those which an 
available artificial cervical disc available in the United States would accommodate, 
and the patient represents a population which, at this time, appears to be too small to 
support a clinical study.  
 
An additional example of a possible custom device might be one manufactured for a 
toddler needing occipital condyle screws after surviving a severe car accident that left 
her paralyzed from the neck down and in need of instrumentation to help hold up her 
head. Her physician concludes that an occiput to C2 posterior cervical fusion would 
be best for her. In the United States, no cleared or approved screws for placement in 
the occipital condyle are available in the sizes needed for this pediatric patient. At this 
time the pediatric patient population requiring posterior occipital condyle fusion 
within the size range the toddler needed could be too small to support a clinical study. 
Because this scenario might satisfy the custom device exemption, her physician 
                                                           
8 For additional information on device labeling, refer to 21 CFR Part 801, 21 CFR 809.10, and Guidance on 
Medical Device Patient Labeling 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070782.htm).  
9 This is not intended to exhaustively list devices that might satisfy the custom device exemption and represents 
only a subset of the information needed to meet the statutory requirements for a valid custom device.  If you 
question whether your scenario might satisfy the custom device exemption, we encourage you to contact 
CDRHs Office of Compliance at customdevice@fda.hhs.gov to discuss. 
  8  Contains Nonbinding Recommendations 
should request custom occipitocervical implants for non-standard, pediatric sized 
screws for use in the occiput, cervical spine and upper thoracic spine of this specific 
patient. The multiple screws used in this procedure would be considered one unit if 
the physician provided the manufacturer with either a statement that the unused 
devices were destroyed or returned them to the manufacturer. FDA expects the 
manufacturer to use appropriate quality system procedures to control returned product 
and ensure they are only redistributed under appropriate circumstance (i.e., another 
valid custom device case or U.S. marketing authorization). 
 
FDA issued a call for comments10 on the use of custom devices in developing this 
guidance document. We received no examples describing a potential physician-
centric custom device. Assuming all other aspects of the custom device exemption in 
the FD&C Act are met, a potential example of a physician-centric medical device 
could be one for a surgical instrument requiring premarket review that needs to be 
modified to accommodate a deformity of a surgeons hand. 
L.  What are some examples of a device that is not a custom device?  
A primary total knee replacement (TKR) patient received company Xs TKR device. 
Later, the patient needs a revision of one side of the TKR joint replacement, which 
use of company Xs currently legally marketed off-the-shelf component for revision 
surgeries could accomplish. However, the hospital where the patients doctor 
practices only uses company Ys products. The doctor would like to request that a 
custom company Y component be made to replace the patients failing company X 
component. This hypothetical situation would not satisfy the requirements for a 
custom device exemption because a legally marketed device is domestically available 
to treat the patient. [See Section 520(b)(1)(D) of the FD&C Act.] This situation may 
be more appropriately addressed through application of the compassionate use 
program in order to distribute the device in interstate commerce without a cleared or 
approved marketing application.  
VI.  Annual Report 
 
The statutory amendments to the custom device exemption under FDASIA added a new 
reporting requirement; namely, that ... the manufacturer of such [custom] device notifies 
the Secretary on an annual basis, in a manner to be prescribed by the Secretary, of the 
manufacture of such device. See 520(b)(2)(C) of the FD&C Act. In short, the manufacturer 
must report to FDA annually on the custom devices it supplied. The annual report should 
include the number of patients who received a new device or revisions of a previous custom 
device. Additionally, multiple custom devices or components used in one patient should be 
accounted for in the annual report. As noted in Section IV of this guidance, typically only 
new custom devices will be counted toward the maximum allotment of five units per year of 
a particular device type. However, revisions to an existing custom device should be 
accounted for in the annual report. Furthermore, the annual report should account for the 
number of custom devices physicians are provided, return to the manufacturer, or destroy. 
                                                           
10 See 77 FR 69488 (Monday, November 19, 2012). 
  9  Contains Nonbinding Recommendations 
  
The annual report should summarize the number of custom devices manufactured and 
distributed in the United States during a 1-year reporting period. Each annual report should 
cover an entire calendar year (i.e., January 1-December 31 of a given year). The first report 
should contain information on custom devices manufacturered e from the date of enactment 
of FDASIA (July 9, 2012) through the date of the first report. For all subsequent reporting 
periods, the report should be submitted to FDA within the first quarter of the following 
calendar year (i.e., no later than March 31). FDA will not enforce the annual reporting 
requirement until the end of the calendar year following publication of the final guidance.  
 
A complete annual report should include all of the information set forth below. FDA can 
review complete annual reports more efficiently, and FDA may be less likely to request 
additional information if a company submits a complete annual report. The following 
sections provide guidance on how to submit an annual report to FDA and the content of that 
report for both patient-centric and physician-centric custom devices. 
A.  Annual Report  General Contents 
The following general information should be included in both patient-centric and 
physician-centric annual reports. 
1.  Cover Letter  
Your report should include a cover letter that clearly states that the reason for 
the submission is a Custom Device Annual Report in the reference line. The 
cover letter should contain your complete contact information (i.e., the 
company name, company address, company website, contact person, contact 
persons title, contact persons phone number, contact persons fax number, 
and contact persons email address). The cover letter should also clearly 
identify the custom devices manufactured and distributed during the reporting 
period, and include the signature of the contact person or other responsible 
party within the company. The cover letter should also specify the reporting 
period (i.e., the dates the reporting period begins and ends).  
2.  Truthful and Accurate Statement 
Your report should include a signed Custom Device Annual Report Truthful 
and Accurate statement that indicates that the submitter is an authorized 
representative for the manufacturer and that all information provided in the 
paper and electronic copies of the Custom Device Annual Report is truthful 
and accurate to the best of your knowledge and that no material fact has been 
omitted. See Appendix II for a copy of the statement we recommend you use.  
3.  Other Logistical Information 
Your Custom Device Annual Report should be written in English. Any 
material provided in a foreign language should be accompanied by an accurate 
and complete English translation. You should send two copies of your Custom 
Device Annual Report to the address below, including at least one hard copy:  
 
  10  Contains Nonbinding Recommendations 
Attn: Custom Device Annual Report Submission Coordinator 
Division of Analysis and Program Operations 
Office of Compliance 
Center for Devices and Radiological Health 
U.S. Food and Drug Administration 
WO66, Room 2622 
10903 New Hampshire Avenue  
Silver Spring, MD 20993-0002  
 
Though not required for Custom Device Annual Reports, we strongly 
encourage you to submit one of the two required copies as an eCopy (i.e., a 
PDF file on a CD, DVD, or flash drive). See eCopy Program for Medical 
Device Submissions: Guidance for Industry and Food and Drug 
Administration Staff 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidan
ce/GuidanceDocuments/UCM313794.pdf) for more information about 
submitting an eCopy. 
B.  Annual Report  Patient-Centric Custom Device Information 
As described in Section V.B. of this guidance, a custom device is either patient-
centric or physician-centric, but not both. In addition to the requested elements listed 
in Section VI.A. (above), the following elements should be provided to FDA in a 
Custom Device Annual Report for patient-centric devices to ensure the conditions 
listed in sections 520(b)(1) and 520(b)(2) are met.  
1.  Explanation of how the device satisfies the elements of Section 520(b) 
of the FD&C Act. 
In your report, you should include a justification for how or why the device 
manufactured to treat an individual patient meets each of the following 
conditions contained in the FD&C Act:11 
a)  To explain how sections 520(b)(1)(B) and (b)(2)(A) are met, you 
should provide an explanation of why the device necessarily deviates from 
the premarket requirements, including treating a sufficiently rare 
condition, such that conducting clinical investigations on it are 
impractical. You may include information on the incidence or prevalence 
of the condition or disease the device is intended to diagnosis, treat, 
mitigate, prevent, or cure, or for which it is otherwise intended to affect 
the structure or any function of the body. References for the data provided 
should also be included. If the incidence or prevalence material referenced 
is not available in the published literature, you should include a copy of 
the reference in the annual report. If you believe that information on the 
incidence or prevalence of the condition or disease is not available, you 
                                                           
11 See Section VII of this guidance document for the complete text contained in section 520(b) of the FD&C 
Act. 
  11  Contains Nonbinding Recommendations 
should provide an explanation why you believe the information is not 
available.  
b)  To explain how section 520(b)(1)(A) is met, you should indicate 
whether the device is a newly created device or modified from an existing 
legally marketed device in order to comply with the order of an individual 
physician.  
c)  To explain how section 520(b)(1)(C) is met, you should attest that the 
device is not generally available in the United States in finished form 
through labeling or advertising by the manufacturer, importer, or 
distributor for commercial distribution.  
d)  To explain how part of section 520(b)(1)(D) and section 520(b)(2)(B) 
are met, you should provide a complete description of the device, 
including device type (e.g., product code, as applicable), as well as the 
patients unique pathology or physiological condition the device was 
designed to treat. 
e)  To show that section 520(b)(1)(D) is met, you should provide a 
statement that no other device is domestically available to treat the 
patients unique pathology or physiological condition. You should 
maintain records of the evaluation that you used to determine that no other 
device is domestically available to treat the patients unique pathology or 
physiological condition. 
f)  To explain how section 520(b)(1)(E)(ii) is met, you should provide a 
unique patient identifier for the individual patient in the physicians order.  
g)  To explain how section 520(b)(1)(F) is met, you should state whether 
the device is assembled from components or manufactured and finished on 
a case-by-case basis to accommodate the unique needs of individuals. 
Additionally, you should explain under section 520(b)(1)(G) whether the 
device or device components have common, standardized design 
characteristics, chemical and material compositions, and the same 
manufacturing processes as commercially distributed devices.  
2.  Summary of Custom Devices Shipped, Used, Returned, and Destroyed 
You should provide a summary of all the custom devices the ordering 
physician supplied, used, returned, and destroyed during the reporting period. 
This includes the name or description of the device and product code (if 
available). This summary should also include information on the number of 
each type of device that was shipped, used/remaining with the patient (e.g., 
implanted) in new and revision patients, and the number of custom devices 
that were returned to the manufacturer/distributor or the ordering physician 
destroyed. To facilitate FDAs review of your summary report, we 
recommend using the format described in Table 1 of Appendix I for reporting 
this information. 
  12  Contains Nonbinding Recommendations 
3.  Details on Custom Device Use 
You should provide the following detailed information on custom devices 
manufactured during the reporting period. 
a)  Patient Information. You should indicate the total number of patients 
receiving custom devices. This should be broken down into patients 
receiving a new device and those undergoing revisions of previously 
existing custom devices. Additional information on the patients should 
also be provided, including unique patient identifiers and a description of 
the condition that necessitated use of a custom device.  
b)  Physician information. You should provide the name, address, and 
other contact information for the treating physician for each patient 
procedure. 
c)  Custom device or custom device components. For each custom device 
or device component remaining with the patient, you should provide 
details on each device or device component.  These details should include 
the date of manufacture; the product name, brand name, product model 
number, product catalog number, or other product identifier information, 
and product code (if applicable).  
To facilitate FDAs review of your detailed custom device report, FDA 
recommends the format described in Table 2 in Appendix I for presenting 
patient, physician, and device information.  
C.  Annual Report  Physician-Centric Custom Device Information 
As described in Section V of this guidance, a custom device is considered to be 
patient-centric or physician centric, but not both. In addition to the requested elements 
listed in Section VI.A. (above), the following elements should be provided to FDA in 
a Custom Device Annual Report for a physician-centric device to ensure that the 
conditions listed in sections 520(b)(1) and 520(b)(2) are met.  
1.  Explanation of how the device satisfies the elements of Section 520(b) 
of the FD&C Act 
In your report, you should include a justification for how or why the device 
manufactured meets the special needs of a physician in the course of his/her 
professional practice and satisfies each of the following conditions contained 
in the FD&C Act:12 
a)  To explain how sections 520(b)(1)(B) and (b)(2)(A) are met, you 
should provide an explanation of why the device necessarily deviates from 
the premarket requirements including addressing a sufficiently rare 
condition, such that conducting clinical investigations are impractical. You 
may include information on the incidence or prevalence of the condition 
                                                           
12 See Section VII of this guidance document for the complete text contained in section 520(b) of the FD&C 
Act. 
  13  Contains Nonbinding Recommendations 
or disease the device is intended to diagnose, treat, mitigate, or prevent. 
References for the data provided should be included. If the incidence or 
prevalence material referenced is not available in the published literature, 
you should include a copy of the reference in the annual report. In 
addition, you should include an explanation of why conducting clinical 
investigations on such device would be impractical. If you believe that 
information on the incidence or prevalence of the condition or disease is 
not available, you should identify why you believe the information is not 
available.  
b)  To explain how section 520(b)(1)(A) is met, you should indicate if the 
device was a newly created device or modified from an existing legally 
marketed device in order to comply with the order of an individual 
physician, as well as the name of the individual doctor in the order.  
c)  To explain how section 520(b)(1)(C) is met, you should attest that the 
device is not generally available in the United States in finished form 
through labeling or advertising by the manufacturer, importer, or 
distributor for commercial distribution.   
d)  To explain how part of section 520(b)(1)(D) and section 520(b)(2)(B) 
are met, you should provide a complete description of the device,; 
including device type (e.g., product code, as applicable), as well as the 
doctors special need that the device was designed to meet.  
e)  To show that sections 520(b)(1)(D) and 520(b)(1)(E)(i) are met, you 
should provide a statement that no other device is domestically available 
to address the doctors special need in the course of conducting his/her 
practice. You should maintain records of the evaluation that you used to 
determine that no other device is domestically available to address the 
doctors or dentists special needs are met. 
f)  To explain how section 520(b)(1)(F) is met, you should explain 
whether the device was assembled from components or manufactured and 
finished on a case-by-case basis to accommodate the special needs of 
individuals described above. Additionally, per 520(b)(1)(G), you should 
explain whether the device or device components have common, 
standardized design characteristics, chemical and material compositions, 
and manufacturing processes as commercially distributed devices.  
2.  Accommodating a Physicians Special Need  
You should provide an annual summary of all the custom devices a physician 
is supplied and/or returns or destroys to accommodate a special need. This 
information should include the name or description of the device and product 
code (if applicable). This summary should also include information on the 
number of each type of device that was shipped/used during the reporting 
period and the number of custom devices that were returned to the 
manufacturer/distributor or the ordering physician destroyed. To facilitate 
  14  Contains Nonbinding Recommendations 
FDAs review of your summary custom device report, we recommend you use 
the format described in Table 1 in Appendix I.  
3.  Details on Custom Device Use 
You should provide the following detailed information on custom devices 
distributed during the reporting period: 
a)  Physician information. You should provide the name, address, and 
other contact information for the physician ordering the custom device. 
b)  Custom device or custom device components. You should provide 
information on the number of custom devices or custom device 
components that were shipped, sold, and returned or destroyed by the 
ordering physician during the reporting period. This includes the date of 
manufacture, the product name, brand name, product model number, 
product catalog number, or other product identifier information, and 
product code (if applicable).  
To facilitate FDAs review of your detailed custom device report, FDA 
recommends the format described in Table 3 in Appendix I for presenting 
 
physician and device information. 
D.  FDAs Review of Your Annual Report  
FDA's review of annual reports allows the agency to assess several important issues 
related to the manufacture and distribution of custom devices. These issues include 
the adequacy of report documentation and fulfillment of the requirements of section 
520(b) of the FD&C Act. If we find that the information provided in your annual 
report is insufficient to allow a complete review, we may request additional 
information by letter, telephone, or e-mail.13 If we only need clarification of an issue, 
we may communicate on such issues either via telephone or e-mail, whichever we 
believe will be the most efficient.  
VII. Complete Text of Section 520(b) of the Food, Drug 
and Cosmetic Act 
Section 520(b) (21 U.S.C. 360j(b)) is amended to read as follows: 
(b) CUSTOM DEVICES. 
(1) IN GENERAL.The requirements of sections 514 and 515 shall not apply to a device 
that 
(A) is created or modified in order to comply with the order of an individual 
physician or dentist (or any other specially qualified person designated under 
regulations promulgated by the Secretary after an opportunity for an oral hearing); 
                                                           
13 Section 520(b)(2)(C) of the FD&C Act now requires that custom device manufacturers submit annual reports 
for all devices distributed under the custom device exemption. Without submission of the required annual report 
to FDA, devices distributed as custom devices would not be exempted from any applicable premarket 
requirements. 
 
  15  Contains Nonbinding Recommendations 
(B) in order to comply with an order described in subparagraph (A), necessarily 
deviates from an otherwise applicable performance standard under section 514 or 
requirement under section 515; 
(C) is not generally available in the United States in finished form through labeling or 
advertising by the manufacturer, importer, or distributor for commercial distribution; 
(D) is designed to treat a unique pathology or physiological condition that no other 
device is domestically available to treat; 
(E)(i) is intended to meet the special needs of such physician or dentist (or other 
specially qualified person so designated) in the course of the professional practice of 
such physician or dentist (or other specially qualified person so designated); or (ii) is 
intended for use by an individual patient named in such order of such physician or 
dentist (or other specially qualified person so designated); 
(F) is assembled from components or manufactured and finished on a case-by-case 
basis to accommodate the unique needs of individuals described in clause (i) or (ii) 
of subparagraph (E); and 
(G) may have common, standardized design characteristics, chemical and material 
compositions, and manufacturing processes as commercially distributed devices. 
(2) LIMITATIONS.Paragraph (1) shall apply to a device only if 
(A) such device is for the purpose of treating a sufficiently rare condition, such that 
conducting clinical investigations on such device would be impractical; 
(B) production of such device under paragraph (1) is limited to no more than 5 units 
per year of a particular device type, provided that such replication otherwise complies 
with this section; and 
(C) the manufacturer of such device notifies the Secretary on an annual basis, in a 
manner prescribed by the Secretary, of the manufacture of such device. 
(3) GUIDANCE.Not later than 2 years after the date of enactment of this section, the 
Secretary shall issue final guidance on replication of multiple devices described in paragraph 
(2)(B).  
Please see Appendix III for a flow diagram of the decision tree needed to implement the 
custom device provisions in the FD&C Act. 
VIII. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520). 
The time required to complete this information collection is estimated to average forty 
hours per response, including the time to review instructions, search existing data sources, 
gather the data needed, and complete and review the information collection. Send 
comments regarding this burden estimate or suggestions for reducing this burden to: 
16  Contains Nonbinding Recommendations
FDA PRA Staff,
Office of Operations,
Food and Drug Administration,
PRAStaff@fda.hhs.gov 
An agency may not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB control number.  
The OMB control number for this information collection is 0910-0767 (To find the 
current expiration date, search for this OMB control number available at 
https://www.reginfo.gov).
17 Contains Nonbinding Recommendations 
Appendix I 
Format for Summary Data Tables
 
 
Table 1. Summary of Custom Devices Shipped, Used and Returned 
Custom Device  Product Code  Number  Number of New Cases  Number of Revision  Number 
Identification  Shipped  Patient-Centric or  Cases (Patient-Centric or  Returned or 
Physician-Centric (as  Physician-Centric)  Destroyed 
applicable) 
           
           
  
Table 2. Patient-Centric Devices - Summary of Patient, Physician and Device Information for Patient-Centric Devices 
Patient  Date of  Description of the  Name and  Custom device or custom  Other relevant Information 
Identifiers  manufacture  condition that  address of  device components 
necessitated use of  physician 
a custom device 
and alternative 
treatments 
        Product name (if specified,)   
Brand name (if specified,) 
Product model number (if 
specified),  
Product catalog number (if 
specified,) 
Other product identifier 
information, 
Product code (if applicable), 
Material composition  
           
  18  Contains Nonbinding Recommendations 
Table 3. Physician-Centric Devices - Summary of Physician and Device Information  
Physician  Date(s) of  Description of special need  Custom device name or  Other relevant information 
name, degree  procedures  necessitating custom device  custom device components 
and address 
      Product name,   
Brand name, 
Product model number,  
Product catalog number, 
Other product identifier 
information, 
Product code, 
Product classification 
regulation, 
Material composition  
         
         
 
  19  Contains Nonbinding Recommendations 
Appendix II 
Custom Device Annual Report Truthful And Accurate 
Statement 
 
I certify that, in my capacity as (the position held in company) of 
(company name), I believe to the best of my knowledge, that all data 
and information submitted in the custom device annual report are truthful and 
accurate and that no material fact has been omitted. 
 
 
_____________________________ 
(Signature) 
______________________________ 
(Typed Name) 
______________________________ 
(Date) 
  20  Contains Nonbinding Recommendations 
Appendix III 
Custom Device Decision Tree 
Note the term physician in the decision tree stands for physician, dentist or specially 
qualified person as noted in Section 520(b) of the FD&C Act. 
 
  21