- Why is CDRH posting lists of guidance documents it intends to issue?
- Does CDRH expect to complete the A-list and B-list?
- Why is CDRH posting a list of guidance documents as part of its retrospective review?
- How do I comment on these lists or a particular guidance document?
- What guidance documents is CDRH considering for development during FY 2019?
- What guidance documents are subject to CDRH's focused retrospective review in FY 2019?
The lists below include guidance documents that CDRH intends to publish this fiscal year (FY 2019), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn. We have provided three lists: (1) a list of guidance documents that the Agency fully intends to publish (the "A-list"); (2) a list of guidance documents that the Agency intends to publish as resources permit (the "B-list"); and (3) a list of final guidance documents that issued in 2009, 1999, 1989, and 1979 subject to focused retrospective review. Although resource constraints and new issues that emerge over the course of the year may preclude CDRH from issuing every guidance document on the A-list and B-list and may require that CDRH issue guidance documents not on the lists, the A-list and B-list are intended to provide helpful information about CDRH's current priorities for the upcoming fiscal year. CDRH plans to update all three lists every year.
CDRH would appreciate comments on any or all of the guidance documents on the three lists to docket FDA-2012-N-1021. Specifically, we are seeking comments on the relative priority of guidance documents. Comments could also include draft language on the proposed A-list and B-list topics, suggestions for new or different guidance documents, for which we request that commenters state the potential guidance topic, reasons the guidance is needed, and proposed policy or information for FDA to consider on the topic. For the retrospective review list, we are seeking suggestions regarding which final guidances should be revised or withdrawn to help inform CDRH's retrospective review of existing final guidances. If a recommendation is made to withdraw or request an existing guidance document, we request that commenters also include information regarding why the guidance document should be revised or withdrawn and, if applicable, how it should be revised. We also welcome any additional feedback for improving the guidance program and the quality of CDRH guidance documents. CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public. The feedback received is critical to the CDRH guidance program to ensure that we meet stakeholder needs. Note that current FDA and CDRH guidance documents can be found on the CDRH Guidance Document Web page.
During negotiations over the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-144) and The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA Reauthorization Act of 2017 (Public Law 115-52), FDA agreed, in return for additional funding from industry, to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly. Among other things, FDA agreed to:
- post annually a list of prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year (FY) (the "A-list");
- post annually a list of device guidance documents that the Agency intends to publish as resources permit each fiscal year (the "B-list");
- update our website in a timely manner to reflect the Agency's review of previously published guidance documents, including the withdrawal of guidance documents that no longer represent the Agency's interpretation of, or policy on, a regulatory issue;
- provide stakeholders an opportunity to provide feedback, including draft language for guidance documents; and
- finalize, withdraw, reopen the comment period, or issue a new draft guidance for 80% of draft guidance documents within 3 years of the close of the comment periods and 100% within 5 years of the close of the comment periods, as resources permit.
Our experience over the years has shown that there are many reasons why CDRH does not complete the entire annual agenda of guidance documents it undertakes. Staff are frequently diverted from guidance development to other activities, including review of premarket submissions or addressing postmarket issues. In addition, CDRH is required each year to issue a number of guidance documents we cannot know about in advance. These may involve newly identified public health issues. It will be helpful, therefore, to receive comments indicating the relative priority of different guidance topics to interested stakeholders. In addition, we intend to consider stakeholder feedback to the docket to help prioritize our allocation of resources to specific guidance topics on the lists.
CDRH has issued over 450 final guidance documents to provide stakeholders with the Agency's thinking on numerous topics. Each guidance reflected the Agency's current position at the time that it was issued. However, the guidance program has issued these guidances over a period of 30 years, raising the question of how current previously issued final guidances remain. CDRH has resolved to address this concern through a staged review of previously issued final guidances in collaboration with stakeholders. CDRH would appreciate external feedback on whether any final guidances that issued in 2009, 1999, 1989, or 1979 should be revised or withdrawn. CDRH intends to provide such lists annually through fiscal year 2025 so that by 2025, FDA and stakeholders will have assessed the applicability of all guidances older than 10 years. For instance, in the annual notice for fiscal year 2020, CDRH expects to provide a list of the final guidance documents that issued in 2010, 2000, 1990, and 1980; the annual notice for fiscal year 2021 is expected to provide a list of the final guidance documents that issued in 2011, 2001, 1991, and 1981, and so on. CDRH will consider the information received from this retrospective review when determining priorities for updating guidance documents.
FDA has established docket FDA-2012-N-1021 for comments on any or all of the proposed fiscal year 2019 guidance documents or guidance documents subject to CDRH's focused retrospective review. FDA would appreciate comments on all three lists, draft language on the proposed A-list and B-list topics, suggestions for new or different guidance documents, relative priority of guidance documents, and/or suggestions that CDRH revise or withdraw a final guidance document that issued previously as part of its retrospective review. FDA believes this docket is an important tool for receiving information from interested parties and for making information available to the public.
Interested persons should submit written comments to the Dockets Management Staff , Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with docket number FDA-2012-N-1021 for "Notice to Public of Website Location of CDRH Fiscal Year 2019 Proposed Guidance Development." Submit electronic comments to http://www.regulations.gov. Received comments will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at http://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. For more detailed information on submission of comments, please refer to the Federal Register notice entitled "Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2019 Proposed Guidance Development."
CDRH is considering to develop a variety of guidance documents in fiscal year 2019. Specific topics and status as final and draft guidance document, are provided in the two lists:
Prioritized medical device guidance documents that the Agency intends to publish in FY 2019 ("A-list")
Final Guidance Topics
- Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
- Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Direct Marking of Inventory
- Breakthrough Devices Program
- Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
- The Least Burdensome Provisions: Concept and Principles
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
- Clinical and Patient Decision Support Software
- Multiple Function Device Products: Policy and Considerations
- Humanitarian Device Exemption (HDE) Program
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- The Special 510(k) Program
Draft Guidance Topics
- Content of Premarket Submissions for Cybersecurity of Medical Devices of Moderate and Major Level of Concern
- Surgical Staplers and Staples – Labeling Recommendations
- Nonbinding Feedback After Certain FDA Inspections of Device Establishments
- Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
- Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies
- Computer Software Assurance for Manufacturing, Operations, and Quality System Software
- Patient Engagement in Clinical Trials
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Lifecycle Regulatory Requirements of Medical Device Servicing (Device Servicer vs Remanufacturer)
- Guidance on an Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Consensus Standards (ASCA).
Device guidance documents that the Agency intends to publish, as the Agency's guidance-development resources permit, in FY 2019 ("B-list")
Final Guidance Topics
- Utilizing Animal Studies to Evaluate Organ Preservation Devices
- Unique Device Identification: Convenience Kits
- Medical X-Ray Imaging Devices Conformance with IEC Standards
- Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
- Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)
Draft Guidance Topics
- Nonclinical Testing and Clinical Considerations for Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation
- Continuous Ventilators - Premarket Notification (510(k)) Submissions
1979 Final Guidances
1989 Final Guidances
- Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA Application
- Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)
1999 Final Guidances
- Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products
- Guidance for Dermabrasion Devices
- Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh
- Guidance on 510(k) Submissions for Keratoprostheses
- In Vitro Diagnostic Fibrin Monomer Paracoagulation Test
- Immunotoxicity Testing Guidance
- Recommended Clinical Study Design for Ventricular Tachycardia Ablation
- Guidance Document for Powered Muscle Stimulator 510(k)s
- Off-The-Shelf Software Use in Medical Devices*
- Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables
- Guidance for Cardiovascular Intravascular Filter 510(k) Submissions
2009 Final Guidances
- Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions
- Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)*
- Procedures for Handling Post-Approval Studies Imposed by PMA Order
- Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria*
- In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency
*Due to amendments to the Federal Food, Drug, and Cosmetic Act made after this guidance document was developed and issued, certain sections of this document may no longer be current. FDA is assessing how to revise this document to represent our current thinking on this topic.