Description
This draft guidance document provides the FDA’s recommendations on information to support premarket submissions for patient-matched guides to orthopedic implants. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of submissions for patient-matched guides to orthopedic implants. This document also provides recommendations that manufacturers should consider when developing their design process for these device types.
Scope & Applicability
Product Classes
6Subject of the guidance document
misaligning the implant compared to the pre-operative planning
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
The primary device subject to the guidance recommendations.
guides used for orthopedic implants; Guides that rely upon a specific geometrical configuration to establish a unique alignment onto the patient's anatomy.
Stakeholders
2Provides medical confirmation of reactions or events; Identifiable reporter in a safety report; Source of medical record numbers; Role responsible for medical confirmation of events; Person entrusted with the direct or indirect provision of healthcare services
Entity responsible for submitting NDINs
Regulatory Context
Attributes
6impact the biocompatibility of the device
Modifications to improve usability of the pre-operative planning report
do not impact upon the guide's structural integrity
Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
requirement for devices labeled as sterile
Requirement for devices provided sterile or non-sterile
Identified Hazards
Hazards
1Interaction between polymeric guides and instruments can generate debris.
Related CFR Sections (4)
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →
- 21CFR801.6§ 801.6 Medical devices; misleading statements.
Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic.Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
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.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (Status: Final)
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (Status: Final)
- CPG Sec. 300.100 Inspection of Manufacturers of Device Components (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Variance from Manufacturer Report Number Format - No. 5 (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)