USFDA Draft Guidance: Quality Management Systems and Menstrual Product Standards

The U.S. Food and Drug Administration (FDA) has recently released two significant draft guidance documents that mark important steps forward in the modernization and harmonization of medical device regulations:

1. Quality Management System (QMS) Information for Certain Premarket Submission Reviews

2. Menstrual Products – Performance Testing and Labeling Recommendations

Both are designed to increase transparency, strengthen product safety and quality, and align FDA’s approach with global best practices.

1. Quality Management System Information for Certain Premarket Submissions

This draft guidance aims to help manufacturers understand FDA’s expectations related to Quality Management System Regulation (QMSR) and its integration into premarket approval (PMA) and Humanitarian Device Exemption (HDE) applications.

Key Highlights

• Harmonization with ISO 13485:2016: The updated QMSR aligns with international quality management standards (ISO 13485:2016 and ISO 9000:2015), streamlining regulatory compliance globally.

• Transition from QS Regulation to QMSR: Effective February 2, 2026, the existing Quality System (QS) Regulation under 21 CFR Part 820 will be replaced with the QMSR. This change ensures better compatibility with global device regulators, reducing duplication and promoting uniformity.

• Essential QMS Elements

  FDA outlines detailed expectations for documentation, including:

  • Risk-based approaches for process control and validation.

  • Management responsibilities, ensuring top leadership accountability for QMS effectiveness.

  • Infrastructure and work environment controls to prevent contamination and product mix-ups.

  • Product realization and development processes that integrate design, purchasing, and production controls.

  • Measurement and improvement mechanisms for data analysis, corrective actions, and change management.

• Premarket Submission RequirementsManufacturers must include in their PMA/HDE:

  • A cover letter specifying manufacturing sites, inspection readiness, and contact details.

  • A summary of device description, manufacturing methods, and QMS compliance documentation.

  • Evidence that manufacturing and quality control methods align with QMSR provisions.

• FDA’s Approach: The agency encourages manufacturers to utilize programs such as Q-Submission and eSTAR for pre-submission feedback, streamlining communication and review.

2. Menstrual Products – Performance Testing and Labeling Recommendations

The FDA’s second major guidance draft focuses on enhancing safety, transparency, and labeling standards for menstrual products including tampons, pads, and menstrual cups. When finalized, it will replace the 2005 guidance “Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)”.

Scope of the Guidance

The document applies to products regulated under 21 CFR 884, such as:

• Tampons (scented and unscented)

• Pads (scented, unscented, intralabial, and reusable)

• Menstrual cups

It introduces detailed testing and labeling expectations to ensure safety and consistency across menstrual product categories.

Key Areas of Focus

1. Performance Testing Recommendations

   • Biocompatibility testing under ISO 10993 to ensure materials do not cause irritation, sensitization, or toxicity.

   • Microbiological assessments to evaluate risks such as Toxic Shock Syndrome (TSS) by examining Staphylococcus aureus growth and toxin production.

   • Contaminant testing, especially for naturally sourced fibers, to confirm absence of pesticides, dioxins, and heavy metals.

   • Non-clinical and clinical testing, validating absorbency, stability, and safety.

2. Labeling Updates for Transparency

   • Mandatory ingredient disclosure, including fragrances, pigments, and deodorants.

   • Clear warnings and usage directions to mitigate infection or misuse risks.

   • Standardized absorbency terms for tampons as defined under 21 CFR 801.430(e).

   • Inclusion of indications for use, device description, and safety information tailored to each menstrual product type.

3. Risk-Based Regulatory Oversight

   • Tampons and menstrual cups generally require 510(k) premarket submissions.

   • Some pad types (e.g., unscented, reusable) may be exempt from 510(k) but still subject to QMS and labeling requirements.

4. Response to Public and Congressional Concerns

   • The FDA’s update follows congressional directives and public demand for ingredient transparency and product safety.

   • An independent systematic literature review (2024) found no safety concerns related to metal exposure from tampons but reinforced the need for rigorous monitoring.