by the kBLASTER Team

The CDRH released today the CDRH Fiscal Year 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance. The CDRH (or the "Agency") 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. This third item, or final guidance documents subject to retrospective review, is described as follows:

"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appreciate external feedback on whether any final guidances that issued in 1985, 1995, or 2005 should be revised or withdrawn."

A number of these 28 proposed "A-list" and "B-list" guidance documents, as well as the 27 existing final guidances from 1985, 1995 and 2005 slated for retrospective review, could have direct or indirect impact on the FDA 510(k) clearance process for new 510(k) submissions, depending on the type of device, requirements or technological characteristics.  The proposed list of "A-list", "B-list" and retrospective review guidances are listed below:

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

What guidance documents are subject to CDRH’s focuses retrospective review during FY2015?

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)

See the full article here.

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