FDA Guidelines

TÜV SÜD - Committed to Following FDA Guidelines for Regulatory Compliance

At TÜV SÜD, we take regulatory compliance seriously and prioritize following FDA guidelines. We understand the importance of adhering to the FDA's recommendations and requirements. Whether it is non-clinical testing, cybersecurity, or the regulation of diagnostic equipment, our experienced team is well-versed in the FDA's guidelines and stays up to date with the latest developments. You can trust TÜV SÜD to provide comprehensive support and expertise in navigating FDA regulations.

Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) - Guidance for Industry and Food and Drug Administration Staff

This FDA guidance outlines the agency's approach to manufacturers' compliance with FDA's performance standards for laser products. While there are similarities between international standards (IEC 60825-1 and IEC 60601-2-22) and FDA's standards, there are significant differences. For manufacturers who conform to specific clauses of the international standards identified as comparable to FDA's regulations, the agency will not enforce the applicable requirements in FDA's regulations.

Key Points:

• FDA provides guidance on manufacturers' compliance with FDA's performance standards for laser products.
• International standards (IEC 60825-1 and IEC 60601-2-22) have similarities but also significant differences compared to FDA's standards.
• Manufacturers conforming to specific clauses of the international standards identified as comparable to FDA's regulations will not face enforcement of applicable requirements in FDA's regulations.
• The guidance aims to provide clarity on compliance expectations for laser product manufacturers.

Medical X-Ray Imaging Devices Conformance with IEC Standards - Guidance for Industry and Food and Drug Administration Staff

This FDA guidance describes the agency's policy on regulating medical x-ray imaging equipment under the FD&C Act and FDA regulations. It seeks to harmonize performance standards with IEC standards, where appropriate, to streamline regulatory reviews. The guidance provides recommendations for industry compliance and allows manufacturers to use a declaration of conformity to equivalent IEC standards to fulfill EPRC requirements. This approach reduces duplication and promotes more efficient and consistent regulatory reviews for medical x-ray imaging devices.

Key Points:

• FDA guidance on regulating medical x-ray imaging equipment under the FD&C Act and FDA regulations.
• Aims to harmonize performance standards with IEC standards for streamlined regulatory reviews.
• Provides recommendations for industry compliance.
• Allows manufacturers to use a declaration of conformity to equivalent IEC standards for EPRC requirements.
• Reduces duplication and enhances efficiency and consistency in regulatory reviews for medical x-ray imaging devices.

Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures - Guidance for Industry and Food and Drug Administration Staff

This guidance document provides the FDA's recommendations on non-clinical performance testing for gynecologic and general laparoscopic power morcellation containment systems. It aims to assist manufacturers in complying with special controls and supports premarket submissions for these devices. The guidance focuses on test methods, parameters, and acceptance criteria. Its purpose is to ensure consistency, streamline review processes, and effectively identify safety issues related to damage and leakage of tumor cells and other contents in the tissue containment system.

Key Learnings:

• FDA guidance document for non-clinical performance testing of gynecologic and general laparoscopic power morcellation containment systems.
• Assists manufacturers in complying with special controls and premarket submissions.
• Provides recommendations on test methods, parameters, and acceptance criteria.
• Promotes consistency and efficient review processes.
• Identifies safety issues related to damage and leakage of tumor cells and other contents in the tissue containment system.

Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff

The FDA guidance document provides recommendations for non-clinical testing, animal studies, clinical studies (when necessary), and labeling to support premarket submissions for peripheral percutaneous transluminal angioplasty (PTA) balloon and specialty catheters. The guidance is specific to PTA catheters that are not combination products or drug-coated PTA catheters. It aims to promote consistency, streamline review processes, and facilitate efficient review of peripheral PTA balloon and specialty catheter submissions.

Key Points:

• FDA guidance on non-clinical testing, animal studies, clinical studies (if needed), and labeling for peripheral PTA balloon and specialty catheters.
• Specifically applies to PTA catheters that are not combination products (excluding drug-coated PTA catheters).
• Recommendations based on current review practices.
• Intended to promote consistency and facilitate efficient review of submissions for peripheral PTA balloon and specialty catheters.

Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act - Guidance for Industry and Food and Drug Administration Staff

The Consolidated Appropriations Act, 2023 introduced amendments to the FD&C Act to ensure the cybersecurity of medical devices. Section 524B outlines cybersecurity requirements that will take effect on March 29, 2023. The FDA will work collaboratively with sponsors of premarket submissions for cyber devices until October 1, 2023, and may issue "refuse to accept" decisions for submissions lacking the required information after that date. The guidance was implemented without prior public comment but will consider received comments for future revisions.

Key Learning:

• The Consolidated Appropriations Act, 2023 amended the FD&C Act to address the cybersecurity of medical devices.
• Section 524B establishes cybersecurity requirements for devices, effective from March 29, 2023.
• The FDA will collaborate with sponsors of premarket submissions until October 1, 2023, regarding the new requirements.
• "Refuse to accept" decisions may be issued for premarket submissions lacking the necessary information after October 1, 2023.
• The guidance was implemented without prior public comment due to time constraints, but public feedback will be considered for future revisions.

Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff

This FDA guidance document provides recommendations for performance criteria in the Safety and Performance Based Pathway for soft (hydrophilic) daily wear contact lenses. It allows submitters to use the proposed criteria instead of direct comparison to a predicate device when seeking substantial equivalence. The guidance aims to promote consistency, streamline the review process, and facilitate efficient premarket submissions for soft daily wear contact lenses.

Key Points:

• FDA guidance on performance criteria for soft (hydrophilic) daily wear contact lenses in the Safety and Performance Based Pathway.
• Submitters can use the proposed criteria instead of comparing to a predicate device for substantial equivalence.
• Aims to ensure consistency, streamline the review process, and facilitate efficient premarket submissions for soft daily wear contact lenses.

General Considerations for Animal Studies Intended to Evaluate Medical Devices - Guidance for Industry and Food and Drug Administration Staff

The FDA guidance document provides recommendations for animal studies evaluating medical devices when suitable alternatives are unavailable. It focuses on assessing device safety in premarket submissions and covers various aspects including personnel credentials, study planning and conduct, animal model selection, study monitoring, testing facility selection, animal housing, records and reports, and preparation of study reports. The recommendations aim to ensure consistency, streamline the review process, and facilitate efficient evaluation of medical device submissions.

Key Points:

• FDA guidance on animal studies for evaluating medical devices when alternatives are unavailable.
• Focuses on device safety assessment in premarket submissions.
• Covers personnel credentials, study planning, animal model selection, study monitoring, testing facility selection, animal housing, records and reports, and study report preparation.
• Aims to ensure consistency and efficiency in the review process.
• Provides recommendations for effective evaluation of medical device submissions.

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff

The FDA plays a crucial role in safeguarding the United States from emerging infectious diseases, including COVID-19. The agency is committed to providing timely guidance to support response efforts during the pandemic. This guidance is issued to assist manufacturers of devices covered by specific enforcement policies enacted during the COVID-19 public health emergency in transitioning back to normal operations once the emergency declaration ends. The FDA believes that following the recommendations outlined in this guidance will facilitate a smooth transition for the agency and other stakeholders back to normal operations and processes.

Key Points:

• Manufacturers of devices covered by COVID-19 enforcement policies are given recommendations for transitioning to normal operations.
• The guidance assists the FDA and stakeholders in resuming normal operations and processes.
• Aims to facilitate a smooth transition post-COVID-19 public health emergency.

Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Guidance for Industry and Food and Drug Administration Staff

This FDA guidance provides recommendations for 510(k) submissions for ultrasonic diathermy devices, also known as physiotherapy devices. Ultrasonic diathermy devices fall under the category of devices as defined by the FD&C Act. The guidance includes recommendations on the use of specific International Electrotechnical Commission (IEC) standards to generate information supporting 510(k) submissions for these devices. It also supplements other FDA documents related to content requirements and recommendations for premarket notification (510(k)) submissions, including 21 CFR 807.87.

Key Points:

• FDA guidance for 510(k) submissions for ultrasonic diathermy devices (physiotherapy devices).
• Ultrasonic diathermy devices are classified as devices under the FD&C Act.
• Recommendations on using specific IEC standards to generate information for 510(k) submissions.
• Supplements other FDA documents related to content requirements and recommendations for premarket notification submissions.
• Aims to provide guidance and support for manufacturers submitting 510(k) applications for ultrasonic diathermy devices.

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff

This FDA guidance provides comprehensive recommendations for 510(k) submissions specifically tailored to diagnostic ultrasound systems and transducers. The document not only outlines regulatory approaches for these devices but also specifies modifications to diagnostic ultrasound devices that do not require a new premarket notification (510(k)) and will not be enforced by the FDA.

Key Points:

• FDA guidance for 510(k) submissions pertaining to diagnostic ultrasound systems and transducers.
• Offers detailed recommendations for these devices.
• Outlines regulatory approaches for diagnostic ultrasound devices.
• Specifies modifications that do not require a new 510(k) submission.
• FDA will not enforce the requirement for a new 510(k) for these specified modifications.
• Provides clear guidelines for manufacturers submitting 510(k) applications for diagnostic ultrasound devices.

Assembler's Guide to Diagnostic X-Ray Equipment - Guidance for Industry and Food and Drug Administration Staff

The Center for Devices and Radiological Health (CDRH) enforces regulations under the Electronic Product Radiation Control (EPRC) provisions of the FD&C Act for diagnostic x-ray equipment. These regulations, known as the Performance Standards for Diagnostic X-ray Systems and Their Major Components, cover manufacturing, importing, and installation of equipment emitting electronic product radiation. Compliance with the Performance Standards and affixing certification labels is required for manufacturers. Proper installation and final testing at the user location are considered the final step in the manufacturing process.

Key Points:

• CDRH enforces regulations under the EPRC provisions of the FD&C Act for diagnostic x-ray equipment.
• Performance Standards for Diagnostic X-ray Systems and Their Major Components govern manufacturing, importing, and installation.
• Compliance with Performance Standards and affixing certification labels is required for manufacturers.
• Proper installation and final testing at the user location are considered the final step in the manufacturing process.

Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff

The FDA published a final rule on June 10, 2005, titled "Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components," which amended the performance standard for these systems. To assist small entities in complying with these changes, the FDA has prepared a Small Entity Compliance Guide in accordance with the Small Business Regulatory Enforcement Fairness Act. The guide aims to provide guidance for complying with the performance standard, which became effective on June 10, 2006. Subsequent amendments to the Radiological Health Regulations removed certain reporting requirements, and the current version of the guidance reflects these changes.

Key Points:

• FDA published a final rule amending the performance standard for diagnostic x-ray systems and their major components.
• Small Entity Compliance Guide prepared in accordance with the Small Business Regulatory Enforcement Fairness Act.
• Intended to assist small entities in complying with the changes in the performance standard.
• Performance standard became effective on June 10, 2006.
• Subsequent amendments removed certain reporting requirements.
• The current version of the guidance reflects the updated regulations.

Surveying, Leveling, and Alignment Laser Products - Guidance for Industry and Food and Drug Administration Staff

The FDA has issued this guidance to provide manufacturers with its approach on the applicability of performance standard regulations to surveying, leveling, and alignment (SLA) laser products. The guidance aims to address manufacturers' questions by covering topics such as defining SLA laser products, providing examples of SLA and non-SLA laser products, and explaining variances and exemptions from SLA laser product class limits.

Key Points:

• FDA guidance outlines the agency's approach to the application of performance standard regulations for SLA laser products.
• Intended to assist manufacturers with their questions and concerns.
• Covers topics including the definition of SLA laser products and examples of SLA and non-SLA laser products.
• Provides information on variances and exemptions from class limits for SLA laser products.
• Aims to provide clarity and guidance for manufacturers regarding FDA's regulations for SLA laser products.