Description
Thisdocumentwas developed to describe our recommendations for IDE applications for total artificial disc devices. It provides guidance for developers on the appropriate pre-clinical tests and clinical trial designs to adequately evaluate the safety of these devices as well as their effectiveness to relieve symptoms of spinal etiology and improve quality of life. This document makes additional recommendations and supplements “Guidance Document for the Preparation of IDEs for Spinal Systems” (i.e., Spinal Systems Guidance).
Scope & Applicability
Product Classes
5Guidance for IDE applications for these specific spinal devices; Guidance for IDE applications for these devices; Guidance for IDE applications for total artificial discs; Subject of the guidance document
Excluded from the scope of this guidance
Excluded from the scope of this guidance
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
The subject of the IDE application guidance; novel spinal devices for motion sparing
Stakeholders
3Branch within ODE responsible for review
assigned as contact point for each site
Independent professional to harvest samples and analyze slides
Regulatory Context
Attributes
7Pre-clinical data requirement
Cybersecurity is part of device safety and effectiveness
Required study duration to assess safety and effectiveness
Inclusion criteria for bony ingrowth or fixation
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
Testing should represent the most extreme design configuration
Characterization of device rotation and movement; Evaluate presence and amount of motion at the treated level
Identified Hazards
Hazards
8Debris generated from durability and wear testing
Potential risk related to loss of motion
Investigation should evaluate the potential for the risk of tumor formation and carcinogenesis
FDA believes that metal ion release is an issue for devices implanted in the spine; Risk due to breakdown products related to device functioning
Risk assessment of superior and inferior components; Potential risk related to device complications
Risk evaluation in more than one loading direction
Risk of device components sinking into vertebral bodies
Risk of movement after implantation
Related CFR Sections (7)
- 21CFR50.25§ 50.25 Elements of informed consent.
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
- 21CFR812.43§ 812.43 Selecting investigators and monitors.
(a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to investigate the device.Read full regulation →
- 21CFR812.25§ 812.25 Investigational plan.
The investigational plan shall include, in the following order:Read full regulation →
- 21CFR812.140§ 812.140 Records.
(a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation:Read full regulation →
- 21CFR860.7§ 860.7 Determination of safety and effectiveness.
(a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.Read full regulation →
- 21CFR812.27§ 812.27 Report of prior investigations.
(a) General. The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation.Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
See Also (8)
- Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology (Status: Draft)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff (Status: Final)
- Pharmacogenomic Data Submissions: Guidance for Industry (Status: Final)
- Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials: Guidance for Sponsors, Clinical Investigators, and IRBs (Status: Final)
- Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Cellular Therapy for Cardiac Disease: Guidance for Industry (Status: Final)