Description
This documentis limited to retinal prostheses, (i.e., visual prosthetic devices implanted on or beneath the retina, and those on or beneath the outer surface of the globe), that use electrical stimulation to provide some level of visual perception for persons suffering from degenerative retinal conditions.
Scope & Applicability
Product Classes
3Visual prosthetic devices implanted on or beneath the retina using electrical stimulation; subject of the guidance document; Subject of the IDE guidance document; Guidance for investigational device exemptions for retinal prostheses
Guidance for industry and FDA staff regarding IDE applications for retinal prostheses.
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.
Stakeholders
3Entity responsible for submitting applications under section 524B
Evaluates functional visual ability of implanted subjects
Institutional Review Board providing study approvals
Regulatory Context
Attributes
6Classification of metallic and calcium phosphate coated orthopedic devices
Based upon the number of subjects needed to evaluate outcomes
requirement for devices labeled as sterile
Categorization (minor, moderate, major) for software risk.
Key factor in determining lifetime durability
Recommended minimum of 5 years for implanted components
Identified Hazards
Hazards
6identified in Failure Mode and Risk Analysis
Warnings regarding compatibility with MRI scanners and magnetic fields
Incompatibilities associated with the retinal prosthesis such as metal detectors or RFID.
Safety consideration for implant electronics
risks due to strong emissions from the MR system
Risk of febrile reaction
Related CFR Sections (9)
- 21CFR812.5§ 812.5 Labeling of investigational devices.
(a) Contents. An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with § 801.1 ), the quantity of contents, if appropriate, and the following statement: “CAUTIORead full regulation →
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
- 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 →
- 21CFR814.82§ 814.82 Postapproval requirements.
(a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device:Read full regulation →
- 21CFR812.46§ 812.46 Monitoring investigations.
(a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this part or other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA shall promptly either securRead full regulation →
- 21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
- 21CFR812.150§ 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:Read full regulation →
- 21CFR812.25§ 812.25 Investigational plan.
The investigational plan shall include, in the following order: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)
- Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards (Status: Draft)
- Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for Industry (Status: Draft)
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Status: Final)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- Investigational Medical Laser Significant Risk Device (Laser Notice 31) (Status: Final)
- Color Additive Petitions - Medical Devices (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)