CDRH Fiscal Year 2015 (FY 2015) Proposed Guidance Development and Focused Retrospective Review of Final Guidance

The lists below include guidance documents that CDRH intends to publish this fiscal year (FY2015) as well as previously-issued final guidances for which CDRH would appreciate external feedback on whether these final guidances should be revised or withdrawn.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 2005, 1995, and 1985 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.

During negotiations over the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114), FDA agreed, in return from 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the Agency’s review of previously published guidance documents, including the deletion of guidance documents that no longer represent the Agency’s interpretation of, or policy on, a regulatory issue, and notation of guidance documents that are under review by the Agency; and
• provide stakeholders an opportunity to provide feedback, including draft language for guidance documents.

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 postmarket problems. 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 as well as special control guidance documents that are necessary for the classification of de novo devices. 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 list.

On June 5, 2014, CDRH held a public workshop to provide stakeholders an opportunity to actively engage with Center representatives about the guidance development process, provide transparency into guidance priority development, promote dialogue on guidance process improvements, and generate ideas for assessing the impact of guidance. One question that was raised was how current do 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 1985, 1995, or 2005 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 2016, CDRH expects to provide a list of the final guidance documents that issued in 2006, 1996, and 1986; the annual notice for fiscal year 2017 is expected to provide a list of the final guidance documents that issued in 2007, 1997, and 1987, 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 2015 guidance documents or guidance documents subject to CDRH’s focused retrospective review. FDA invites interested persons to submit comments on all three lists, draft language on the proposed A-list and B-list topics, suggestions for new or different guidance documents (for which commenters should state the potential guidance topic, reasons the guidance is needed, and proposed policy for FDA to consider on the topic) , 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 (for which commenters should address why the guidance document should be revised or withdrawn and, if applicable, how it should be revised). FDA believes this docket is an important tool for receiving information from interested parties and for making information available to the public.

CDRH is considering developing a variety of guidance documents in fiscal year 2015. 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 2015 (“A-list”)

Final Guidance Topics

• Applying Human Factors Usability Engineering to Optimize Medical Device Design
• 510(k) Submissions for Medical Devices that Include Antimicrobial Agents  
• Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
• Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Need for Life Threatening of Irreversibly Debilitating Diseases or Conditions
• Framework for Regulatory Oversight of Laboratory Developed Tests
• FDA Notification and Medical Device Reporting for Laboratory Developed Tests
• Coronary Drug Eluting Stents-Nonclinical and Clinical Studies
• Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements
• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
• Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections With Small-bore Connectors Intended for Enteral Applications
• Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile
• Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility)

Draft Guidance Topics

• General Wellness Products
• Medical Device Accessories
• Medical Device Decision Support Software
• Benefit-Risk Factors to Consider When Reviewing IDE Submissions
• UDI Direct Marking
• Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements
• Adaptive Design for Medical Device Clinical Studies
• UDI FAQs

Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2015 (“B-list”)

Final Guidance Topics

• Finalizing existing draft guidance documents.

Draft Guidance Topics

• Medical Device Interoperability
• Transfer of Ownership of a Premarket Notification: Questions Answers
• Direct Access Genetic In Vitro Diagnostics Testing (also known as Direct to Consumer Genetic Testing)  
• Patient Access to Information
• 3D Printing (Technical)  
• Manufacturing Site Change Supplements
• Use of Symbols in Labeling

1985 Final Guidances

• Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF – 90KB) (1/20/1985)
• User Instruction Hazard Warnings (Laser Notice 35) (PDF – 63KB) (2/5/1985)
• Policy on Warning Label Required on Sunlamp Products (PDF – 71KB) (6/25/1985)
• Low Power Laser Exemption (Laser Notice 36) (PDF – 101KB) (8/23/1985)
• Walk-In Workstations (Laser Notice 37) (PDF – 86KB) (10/21/1985)

1995 Final Guidances

• Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters (PDF – 896KB) (3/15/1995)
• Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians’ Office Laboratory and Home Use (7-13-1995)
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment (7/26/1995)
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes (7/26/1995)
• Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles (7/26/1995)
• Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Immersion Hydrobaths (7/26/1995)
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables(7/26/1995)
• Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems (7/26/1995)
• Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators (7/26/1995)
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices (7/26/1995)
• User Instruction for Medical Products (Laser Notice 44) (PDF – 123KB) (8/11/1995)
• Labeling of Laser Products (Laser Notice 45) (PDF – 90KB) (8/15/1995)
• Guidance On The Content Of Premarket Notification [510(K)] Submissions For Protective Restraints (Text Only) (12/1/1995)

2005 Final Guidances

• Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (1/14/2005)
• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)
• Guidance for Industry and FDA Staff – Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (7/27/2005)
• Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features (8/9/2005)
• Guidance for Industry – Review Criteria for Assessment of C Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays (9/22/2005)
• Guidance for Industry and FDA Staff: Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions (10/26/2005)
• Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30) (11/6/2005)
• Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures (11/10/2005)
• Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s (11/17/2005)