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

Description

The Food and Drug Administration (FDA) has developedthis documentto 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.

Scope & Applicability

Product Classes

2

Custom Device

Guidance regarding the implementation of the custom device exemption; devices created or modified to comply with the order of an individual physician or dentist; Devices meeting specific criteria under section 520(b) for exemption; Devices created or modified to comply with the order of an individual physician; Devices exempt under specific FD&C Act provisions

Patient-specific devices

Also referred to as patient-matched devices, generally cleared via 510(k) or PMA

Stakeholders

4

Physician

Allowed value for reporter qualification

Importer

Must comply with registration if meeting facility/responsible person definitions

Manufacturer

Entity responsible for submitting NDINs

Ordering Physician

Professional who orders a custom device for a specific patient

Regulatory Context

Attributes

4

5 units per year

Statutory limit for a particular device type under the exemption; Production limit for a particular device type under the exemption

sufficiently rare

Condition where clinical investigations would be impractical

Material composition

Required data element for patient-centric and physician-centric devices

Five units per year

Statutory limitation for a particular device type under the custom device exemption; Maximum allotment for a particular custom device type

Related CFR Sections (3)

21CFR860.3§ 860.3 Definitions.
For the purposes of this part:Read full regulation →
21CFR801.1§ 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
(a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.Read full regulation →
21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →

Related Warning Letters (10)

CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
2025-10-28
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
2025-10-21
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
2025-10-07
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
2025-09-30
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
2025-09-23
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
2025-09-16