Denture Base Resins - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

Description

This guidance document provides the FDA's recommendations on performance criteria to support premarket submissions for denture base resins in theSafety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for denture base resins will have the option to use the performance criteria proposed in this final guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of denture base resins submissions.

Scope & Applicability

Regulatory Context

• 21CFR872.3560§ 872.3560 OTC denture reliner.

  (a) Identification. An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available foRead full regulation →

• 21CFR872.3760§ 872.3760 Denture relining, repairing, or rebasing resin.

  (a) Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counteRead full regulation →

• Product Labeling for Laparoscopic Power Morcellators: Guidance for Industry and Food and Drug Administration Staff
• Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
• Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff
• Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff
• Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
• Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration Staff
• Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards
• Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff