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FDA’s Center for Devices and Radiological Health (CDRH) released guidance documents that the agency is planning to publish in 2024. CDRH is seeking comments from industry stakeholders on the proposed recommendations by December 11.
The proposed guidance documents are divided into three sections. The A-list contains documents FDA intends to publish; the B-list contains documents FDA plans to publish if the necessary resources are available.
These final guidance documents made the A-list:
- Remanufacturing of Medical Devices
- Medical Device Shortages – Implementation of Section 506J of the Federal Food, Drug and Cosmetic Act
- Marketing Submission Recommendations for Artificial Intelligence/Machine Learning-enabled Device Software Functions.
The A-list includes numerous draft guidance documents, including:
- Artificial Intelligence/Machine Learning (AI/ML)-enabled Device Software Functions: Lifecycle Management Considerations and Premarket Submission Recommendations
- Select Updates for Premarket Cybersecurity Guidance: Cyber Devices
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program
The B-list contains two final guidance documents:
- Computer Software Assurance for Production Quality System Software
- Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
The B-list contains one draft guidance:
- 3D Printing Medical Devices at the Point of Care
FDA is also seeking a retrospective review of final guidance documents issued in 1984, 1994, 2004 and 2014 to determine which documents should be revised or withdrawn to help inform existing final guidances.
FDA is seeking comments on the relative priority of the guidance documents on the A and B lists and proposed policies or information for FDA to consider for inclusion in these guidances. The agency is also accepting suggestions for new or different guidance documents and reasons why guidance on a suggested topic is needed.
Here are instructions for submitting comments electronically by December 11.
Dan Goldstein, Senior Director of Quality Assurance at MCRA, highlighted the following guidance documents as of particular importance to medical device manufacturers and plans to provide breakdowns of each for BONEZONE readers in the coming months.
Remanufacturing of Medical Devices. FDA noted that many medical devices are reusable and need preventive maintenance and repair during their useful life. The agency cited a lack of clarity regarding the distinction between “servicing” and “remanufacturing” of a device. “Most notably, remanufacturing has implications for the regulatory responsibilities of entities performing these activities,” FDA said in the draft guidance.
Clarifying the difference between servicing and remanufacturing is needed to bring consistency and understanding to statutory and regulatory requirements, according to FDA. The draft guidance includes information that should be included in labeling to ensure the quality, safety and effectiveness of devices that need to be serviced over their shelf life.
Computer Software Assurance for Production and Quality System Software. FDA said this guidance intends to define “computer software assurance” as a risk-based approach to establish confidence in the automation used for production or quality systems. The guidance also intends to describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements.
3D Printing Medical Devices at the Point of Care. FDA said 3D printing at hospitals and other settings enables healthcare professionals to quickly create patient-matched devices and anatomical models for surgical planning. However, the potential benefits of the practice come with challenges that need to be addressed. In December 2021, FDA released a discussion paper to gather feedback from stakeholders and develop an appropriate regulatory oversight approach for 3D printing at the point of care.
Goldstein said it’s important to inform FDA about your assessment of guidance documents during the comment period.
“Submitted comments occasionally influence the wording of a draft guidance or regulation,” he explained. “However, even when final guidance documents remain unchanged, released regulations typically include an extensive preamble in which responses to submitted comments are presented.”
FDA’s responses to submitted comments often clarify the intent of recommendations included in final guidance documents, Goldstein noted.
“This aspect proves highly valuable,” he said. “We assist our clients in leveraging preambles and guide them in using the precise language to show FDA investigators what regulations should entail. When questioned about your interpretation of a regulation during an inspection, guidance documents can be used to defend your actions.”
