Description
A number of Federal and state agencies which share responsibility for the regulation or licensure of medical testing laboratories are concerned about allergy clinics, health centers, and testing laboratories performing the cytotoxic test and promoting the test as effective in the detection of allergic diseases, particularly for food and food additives. The Health Care Financing Administration (HCFA) and the Federal Trade Commission (FTC) have asked FDA to assess the validity, accuracy, and effectiveness of "in vitro" cytotoxic testing as a diagnostic tool. FDA is concerned that businesses may begin distributing kits for cytotoxic testing for which efficacy has not been established.
Scope & Applicability
Product Classes
2The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Classification name for the device
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
1support the use of the proposed cycle and the desired sterility assurance level
Related CFR Sections (2)
- 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 →
- 21CFR876.1500§ 876.1500 Endoscope and accessories.
(a) Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optRead full regulation →
Related Warning Letters (2)
- 2023-06-06
Medical Devices/Adulterated/Quality System Regulation (QSR)
iRhythm Technologies, Inc.
- 2020-04-21
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Tenderneeds Fertility LLC
See Also (8)
- Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (Status: Final)
- CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (Status: Final)
- Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] (Status: Final)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- CPG Sec. 335.300 Hypnotherapy Devices - Self-Hypnotic Tape Recordings (Status: Final)