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Industry Update – Guidance Document published by FDA for Small Entities

June 28, 2024June 28, 2024by valueaddedinLeave a comment

Small Entity Compliance Guide – Guidance Document published by FDA

FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests” (“LDT Final Rule”), amending FDA regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory .

The FDA has published a Guidance document for small entities – “Small Entity Compliance Guide” to assist small entities to comply with the requirements established in FDA regulations as they apply to IVDs, including LDTs.

Click here to read the Guidance Document

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/laboratory-developed-tests-small-entity-compliance-guide

Industry Update – QMSR for Medical Devices

February 16, 2024February 16, 2024by valueaddedinLeave a comment

Quality Management System Regulation (QMSR) for Medical Devices

The Quality Management System Regulation (QMSR) for Medical Devices, released by the FDA on January 31, 2024, is a significant update to the existing Quality System (QS) regulation (21 CFR Part 820). This new rule aims to:

Harmonize with international standards, specifically the ISO 13485:2016 standard for medical device quality management systems. This will streamline processes for manufacturers who export to other countries.

Modernize the requirements, reflecting best practices in quality management and aligning with current technologies and approaches.

Increase flexibility for manufacturers, allowing them to tailor their quality systems to their specific needs while still meeting essential safety and effectiveness requirements.

Key points of the QMSR:

Incorporation by reference of ISO 13485:2016: This means that manufacturers can largely follow the ISO standard to meet the FDA’s requirements, with some additional clarifications and modifications outlined in the QMSR.

Focus on risk management: The QMSR emphasizes a proactive approach to identifying and mitigating potential risks throughout the product lifecycle.

Quality by design: The QMSR encourages manufacturers to build quality into their products from the start, rather than relying on inspections and testing to catch problems later.

Increased transparency: The QMSR requires manufacturers to maintain more comprehensive documentation and make certain information available to the FDA upon request.

Important dates:

Publication date: January 31, 2024

Effective date: February 2, 2026

The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.

Source: https://www.fda.gov/

Electronic Export Documents

January 5, 2024January 5, 2024by valueaddedinLeave a comment

Transition to Electronic Export Documents

The U.S. FDA’s Center for Devices and Radiological Health (CDRH) has transitioned from paper to electronic export documents for medical devices.

Starting January 2, 2024, certificates like CFG, COE, and NCR will be electronically issued as downloadable PDFs via CECATS.

Recipients have 45 days to access and print the document.

Verification can be done through the FDA’s FECV system using a QR code, and certificates remain valid for 2 years.

Electronically issued documents include:

Certificate to Foreign Government (CFG);
Certificate of Exportability (COE) under section 801(e)(1) or 802 of the Food, Drug, and Cosmetic Act (the FD&C Act);
Non-Clinical Research Use Only Certificate (NCR);
Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE); and
Export Permit Letter

Any queries regarding electronic export documents for medical devices, please email to Exportcert@cdrh.fda.gov.

Source: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry