Description
Natural sea sponges have been promoted as "menstrual sponges," "hygienic sponges," and "sanitary sponges" for use as menstrual tampons. Public interest in these products has grown since the publicity associating toxic shock syndrome with the use of menstrual tampons.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
4Subject of the guidance document; Information about the product structure is critical in determining equivalence
Medical devices intended for human use; Approved or cleared medical devices
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Information about the product structure is critical in determining equivalence
Stakeholders
1Entity providing guidance documents upon request
Regulatory Context
Regulatory Activities
2Premarket notification submission type
clinical data for dura substitutes composed of material not previously used
Document Types
5Documentation artifact related to NDI notifications
Document element that should include specific indications and target populations
Document indicating analytical results of testing; record relied on to control L. monocytogenes in ingredients; document provided for a food prior to or upon receipt of the food; COA documentation
Information on material components
MDS-specific information should be documented and collected on the case report forms
Attributes
2Standard for 510(k) clearance
Required label element for outsourcing facilities
Technical Details
Substances
6Regulated as medical devices, distinct from synthetic dura substitutes.
Alternative material to human dura
primary material of menstrual cups
Alternative material to human dura
Alternative material to human dura
sterilization facilities that use a gas called ethylene oxide (EtO) to sterilize medical devices; Common method of terminal sterilization of medical devices; sterilization facility change involving EtO; Sterilant used in the manufacturing process
Testing Methods
6Used to assess irritation for EtO sterilized devices
Used to protect patients from febrile reactions
used to evaluate surface structure
subsequent assessment is not necessary for cytotoxicity
includes bacterial reverse mutation assay
rodent carcinogenicity studies
Processes
2Required for contaminated equipment and media before disposal
The device should be evaluated by conducting implantation studies at the intended anatomic site
Clinical Concepts
3Safety events that must be tracked for different updates
Specific patient groups to be identified in labeling
Specific clinical uses to be included in the intended use statement
Identified Hazards
Hazards
2hazard associated with animal food facilities
Addressed in ICH Q5A (R2)
Standards & References
External Standards
3Standard for ethylene oxide sterilization residuals
United States Pharmacopeia standards for compendial drug substances; confirming conformance to the application-approved specification and USP
International standards development organization cited for scientific standards
Specifications
2Sterility Assurance Level (SAL) stated
Examples include device thickness, pore size, and residual levels of manufacturing reagents
ICH References (1)
Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
Related CFR Sections (2)
- 21CFR882.5910§ 882.5910 Dura substitute.
(a) Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).Read full regulation →
- 21CFR860.7§ 860.7 Determination of safety and effectiveness.
(a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.Read full regulation →
Enforcement Impact
Deficiencies cited in Warning Letters referencing the same regulations
Related Warning Letters (1)
See Also (8)
- CPG Sec. 345.200 Diaphragms - Rx Devices (Status: Final)
- CPG Sec. 398.200 Hazardous Diagnostic X-ray Systems (Status: Final)
- CPG Sec. 355.300 Ion Generating Devices (Status: Final)
- Guidance Document for Dura Substitute Devices - Guidance for Industry (Status: Final)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff (Status: Final)
- Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry (Status: Final)
- Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff (Status: Final)