Description
Comments and suggestions may be submitted at any time for Agency consideration to Plastic and Reconstructive Surgery Branch, HFZ-410, 9200 Corporate Boulevard, Rockville, MD 20850. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact Charles N. Durfor, Ph.D. at 301-796-6438 or by electronic mail atcharles.durfor@fda.hhs.gov.
Scope & Applicability
Product Classes
3Devices requiring documentation of product resorption rates.
79 FTL for general surgical uses
general surgical uses such as implantation to reinforce soft tissue; The primary device subject to this guidance document.
Stakeholders
2Entity responsible for submitting applications under section 524B
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Regulatory Context
Attributes
2should be based on appropriate supportive stability data
The standard for clearing a 510(k) device relative to a predicate.
Identified Hazards
Hazards
2Safety concern for devices that polymerize in situ.
Causative agent requiring inactivation controls
Related CFR Sections (3)
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information: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 →
- 21CFR878.3300§ 878.3300 Surgical mesh.
(a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.Read 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)
- Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources - Guidance for Industry (Status: Final)
- Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/Staff (Status: Final)
- Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems : Guidance for Industry (Status: Final)
- Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators - Guidance for Industry (Status: Final)
- Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm) - Guidance for Industry (Status: Final)
- Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement) - Guidance for Industry (Status: Final)
- Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k)) (Status: Final)