FDA - Proposed Rules To Implement FSMA

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Updated December 19, 2020

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Frequently Asked Questions on FSMA - FDA.gov

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The FDA has released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety. These rules are two of the proposed rules that are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (FSMA). The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow. FDA expects to soon issue its proposed rule on importer foreign supplier verification; future proposed rules will address preventive controls for animal food, and accreditation of third-party auditors.:

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, and 
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

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2013 Plan For FDA CDRH Guidance Documents

The CDRH is considering developing a variety of guidance documents in fiscal year 2013. Specific topics and status as final and draft guidance document, are provided in the two lists:

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Prioritized medical device guidance documents that the Agency intends to publish in FY 2013 ("A-list")

Final Guidance Topics

• Refuse to Accept (RTA) Policy for 510(k) Submissions
• Acceptance and Filing Review for Premarket Approval Applications
• Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
• In Vitro Companion Diagnostic Devices
• Design Considerations for Pivotal Clinical Investigations for Medical Devices
• De Novo Classification Process (Evaluation of Automatic Class III Designation)
• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
• CDRH Appeals Processes
• Medical Device Classification Product Codes
• The Pre-Submission Program and Meetings with FDA Staff
• Mobile Medical Applications
• eCopy
• Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

Draft Guidance Topics

• Distinguishing and Reporting Medical Device Recalls from Product Enhancements
• Types of Communication During the Review of Medical Device Submissions
• FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
• eCopy
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

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Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2013 ("B-list")

Final Guidance Topics

• Finalizing existing draft guidance documents.

Draft Guidance Topics

• Benefit-Risk Determinations in Premarket Notifications (510(k)s)
• Direct to Consumer (DTC) Genetic Testing: IVDs
• Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
• Custom Devices

Reference:  FDA CDRH Fiscal Year 2013 (FY 2013) Proposed Guidance Development

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