Custom Device Exemption

Nathan S. Ivey, PhD

Regulatory Health Project Manager

Office Product Evaluation and Quality (OPEC)

Center for Devices and Radiological Health

U.S. Food and Drug Administration

Learning Objectives

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1. Describe Custom Device Exemption and its key 

concepts

2. Discuss the 5 per year allotment limit 

3. Explain the annual reporting requirements
What is a Custom Device Exemption?

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Regulatory Authority

Section 520(b) of the Food, Drug, and Cosmetic Act 

(FD&C Act) provides the basis for the Custom Device 

Exemption Program

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Section 520(b) Food, Drug and Cosmetic Act
What is Generic Device Type?

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 

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What is 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

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Requirements of a Custom Device 

Exemption

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PMA and Performance Standards

Sections 514 and 515 of the FD&C Act do not apply to 

devices that meet the requirements for a custom device

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Custom Device

• Written request of a physician or dentist to meet a 

need

• Not generally available in the US in finished form

• Firms should not solicit orders for custom devices

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Section 520(b)(1)(A) and (B) Food, Drug and Cosmetic Act
Patient-Centric

• Patient with unique physiology or pathology

• Example: physiology

– A custom device that is outside of the legally marketed 

envelope of available devices 

– A patient who requires an oversize hip replacement that 

is beyond the legally marketed size limit

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Section 520(b)(1)(D) Food, Drug and Cosmetic Act
Physician (or Dentist)-Centric

• For a physician or dentist with a unique pathology or a 

unique physiologic condition, a special need device could 

be made for them in their practice

• Example: condition

– A custom device to meet a physician’s need for an adaptive 

device to perform surgery because of a permanent hand 

injury may qualify (specialized handle on their surgical 

instrument)

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Section 520(b)(1)(E) Food, Drug and Cosmetic Act
Case-by-Case Basis

• A custom device is produced on a case-by-case basis

• A custom device may have similar design 

characteristics, materials and manufacturing processes 

in common with commercially distributed devices

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Section 520(b)(1)(F) and (G) Food, Drug and Cosmetic Act
Modified Devices

• A legally marketed device that has been modified may 

not be a custom device

• 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

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Personalized or Patient Fitted

• A personalized or patient fitted device is a device that is legally 

marketed in a form that is modified prior to being used in each 

patient. These are not custom devices

• Examples: 

– A dental abutment where each patient has a differently shaped 

oral space and the device blank is milled for individual patients, is 

not a custom device 

– An orthopedic 3D printed device where a conventional device has 

been cleared for patients, is not a custom device

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Regulatory Requirements

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Quality Systems Regulation 21 CFR 820

• Custom Devices are NOT exempt from the QS regulation

• Additional regulatory requirements for custom devices: 

– Medical Device Reporting (21 CFR Part 803) (adverse event 

reporting)

– Labeling (21 CFR Part 801)

– Corrections and Removals (21 CFR Part 806)

– Registration and Listing (21 CFR Part 807)

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Medical Device Labeling

• Adequate directions for use

• May not be false or misleading

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21 CFR 801

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801
Custom Device Labeling

• Statement that the device is a custom device

• Name of the ordering physician

• Identifying information for the patient (if applicable)

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• Indications for use

• Sterilization status

• Relevant composition information

– materials, components

• Storage conditions

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Custom Device Labeling
Custom Device Exemption Allotment

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No More Than 5 Per Year

• Limited to no more than 5 allotments per year of a 

generic device type

– Five new patients, allotments, for the patient-centric 

– Five new physicians, allotments for the physiciancentric 

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One Allotment or Two? 

• 1 patient with a unilateral hip replacement in one calendar year is one 

allotment in the annual report

• 1 patient, bilateral hip replacement in one calendar year is one 

allotment in the annual report

• 1 patient, bilateral hip replacement across two calendar years is two 

allotments in the annual reports

• 1 patient, four devices made in four sizes. One implanted and three 

destroyed or returned in one calendar year is one allotment in the 

annual report

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Custom Device Annual Report

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Custom Device Annual Report

• The report provides an accounting and justification that 

each device supplied by a manufacturer to a patient or 

physician as a custom device meets the statutory 

requirements

• Submit the report annually by March 31st for devices issued 

the prior calendar year (January 1 through December 31)

• Provide a hard copy of the report in English

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Where to Submit Report

Email the Custom Device Exemption program for the 

current address to submit your annual report:

CustomDevices@fda.hhs.gov

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Report Contents

Template format provided in Appendix 1 of the guidance

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Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff

www.fda.gov/regulatory-information/search-fda-guidance-documents/custom-deviceexemption
Annual Report-General Contents

• Cover letter

– Contact information

– Reporting timeframe

– Number of devices manufactured and distributed

– Signature

• Truthful and Accurate Statement

• Other Logistical Information

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Patient-Centric Report

• Justification for how or why the device manufactured 

to treat an individual patient meets the following:

– Deviates from the premarket requirement

– Whether newly created device or modified device from 

a legally marketed device

– Statement that it is not generally available

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– Description of device

– Statement to treat patient’s unique pathology or 

physiological condition

– How device is assembled from components or 

manufactured, and finished

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Patient-Centric Report (continued)
Patient-Centric Report (continued)

• Patient and Physician Information

– Patient information, including unique patient identifiers 

– Physician information

– Custom device or custom device components

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Physician-Centric Report

• Justification how or why device is unique, special need 

condition:

– Deviates from the premarket requirement

– Whether newly created device or modified from a 

legally marketed device

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– Statement that it is not generally available

– Statement special need in course of conducting their 

practice

– Description of device

– How device is assembled from components or 

manufactured, and finished

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Physician-Centric Report (continued)
Physician-Centric Report (continued)

• Custom devices distributed

• Physician information

– name, address, and other contact information 

• Device or components

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FDA Annual Report Review

• Provides an acknowledgement receipt of report

• Notice that the report has been approved

• If we have questions or concerns, we will reach out to 

you for more information

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Providing Industry Education

1. CDRH Learn – Multi-Media Industry Education

• Videos, audio recordings, power point presentations, software-based “how to” 

modules describing aspects of medical device and radiation emitting product 

regulations:

www.fda.gov/CDRHLearn

2. Device Advice – Text-Based Education

• Text-based resource that explains many aspects of medical device laws, 

regulations, guidances, and policies:

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

3. Division of Industry and Consumer Education (DICE)

• If you have a question - Email: DICE@fda.hhs.gov

• Phone: 1(800) 638-2041 or (301) 796-7100 (Live Agents 9am – 12:30 pm; 1-

4:30 pm EST)

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Contact

• Email

CustomDevices@fda.hhs.gov

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References 

• Custom Device Exemption Guidance for Industry and Food and Drug 

Administration Staff

www.fda.gov/regulatory-information/search-fda-guidancedocuments/custom-device-exemption

• Technical Considerations for Additive Manufactured Medical Devices

www.fda.gov/files/medical%20devices/published/TechnicalConsiderations-for-Additive-Manufactured-Medical-Devices---

Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdf

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Summary

• A Patient-Centric Custom Device is a unique device to treat 

unique Pathology or Physiology of a patient 

• A Physician-Centric Custom Device is a unique device to 

meet the special need or condition of a physician or dentist

• A custom device is limited to 5 device allotments per year

• Annual reporting is required for Custom Device Exemption

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Your Call to Action

• Ensure custom devices used in patients or by physicians 

qualify for a custom device exemption

• Follow all custom device requirements

• Submit Annual Reports on time and include all the 

necessary information

• Submit a Q-Submission request for device-specific 

questions

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