Description
For questions regarding this document contact Karen H. Baker, MSN, RN, at 240-276-4242 orkaren.baker@fda.hhs.gov
Scope & Applicability
Product Classes
3Devices intended to medialize a paralyzed vocal fold to improve voice quality and/or airway protection.; Devices identified as procode MIX or KHJ covered by this guidance.
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
addressed by this guidance document is a significant risk device
Stakeholders
2Entity responsible for submitting NDINs
device is to be used by trained professionals on patients
Regulatory Context
Attributes
1Classification of metallic and calcium phosphate coated orthopedic devices
Identified Hazards
Hazards
3Identified risk to health associated with the device.
safety consideration in surgeon's instructions
Risk where particles less than 65µm migrate to regional lymph nodes.
Related CFR Sections (6)
- 21CFR874.3620§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a) Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closRead full regulation →
- 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 →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read 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 →
- 21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read 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 →
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
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-07-15
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WHOOP, Inc.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
See Also (8)
- 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations (Status: Final)
- Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Intravascular Administration Sets Premarket Notification Submissions [510(k)]: Guidance for Industry and FDA Staff (Status: Final)
- Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)
- Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)