The lists on this page include guidance documents that CDRH intends to publish this fiscal year (FY 2020), 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which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn.
These lists are:
- The A-list: A list of prioritized device guidance documents that the Agency intends to publish during FY2020.
- The B-list: A list of device guidance documents that the Agency intends to publish as resources permit during FY2020.
- Retrospective review list: A list of final guidance documents issued in 1980, 1990, 2000, and 2010.
A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2020
Final Guidance Topics
- 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
- 510(k) Third Party Review Program
- Safer Technologies Program for Medical Devices
- Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices
- Labeling Recommendations for Surgical Staplers
- Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments
- The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Recognition and Withdrawal of Voluntary Consensus Standards
- Clinical Decision Support Software
- Multiple Function Device Products: Policy and Considerations
- Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation
Draft Guidance Topics
- Labeling and Informed Decision Checklist for Breast Implants
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Distinguishing between Medical Device Servicing and Remanufacturing
- Computer Software Assurance for Manufacturing, Operations, and Quality System Software
- Procedures for Handling Post-Approval Studies Imposed by PMA Order (revision)
- Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act (revision)
- Unique Device Identification: Policy on Enforcement of GUDID Submission Requirements for Certain Class I Devices
- Pragmatic Generation of Validity Evidence for Patient-Reported Outcome Measures Used in Medical Device Submissions
- Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation
B-List: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2020
Final Guidance Topics
- Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
- 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
- Point-of-Care Prothrombin Time/International Normalized Ratio Monitoring Systems for Professional Use and Prescription Self-Monitoring Use
- Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy and Considerations
Retrospective Review List of Guidances for 1980, 1990, 2000, and 2010
1980 Final Guidances
- Open Door Operation of Microwave Ovens as a Result of Oven Miswiring
- Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard
- Alternate Wording For Caution Statement (Laser Notice 30)
1990 Final Guidances
- Implantable Pacemaker Testing Guidance
- Reviewer Guidance for Automatic X-Ray Film Processor 510(k)
- Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases
- Guidance on 510(k) Submissions for Implanted Infusion Ports
2000 Final Guidances
- Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants – Guidance for Industry and FDA Reviewers
- Guidance Document for the Preparation of IDEs for Spinal Systems – Guidance for Industry and/or FDA Staff
- Guidance for the Content of Premarket Notifications for Penile Rigidity Implants – Guidance for Industry and for FDA Staff
- Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer: Guidance for Industry and for FDA Reviewers
- Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements – Guidance for Industry and for FDA Reviewers/Staff
- Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers: Guidance for Industry
- Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses – Guidance for Industry
- 1-Consolidated Annual Report for a Device product line (1-CARD) – Guidance for Industry and CDRH Reviewers
- Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources – Guidance for Industry
- Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi – Guidance for Industry and for FDA Reviewers
- Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 – Guidance for Industry and for FDA Reviewers
- Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals: Guidance for Industry and for FDA Staff
- Labeling for Electronic Anti-Theft Systems: Guidance for Industry
- Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter – Final Guidance for Industry and FDA Reviewers
- Guidance Document for Dura Substitute Devices – Guidance for Industry
- Guidance for Extracorporeal Blood Circuit Defoamer – 510(k) Submissions – Final Guidance for Industry and FDA
2010 Final Guidances
- Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
- Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff
- In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions: Guidance for Industry and FDA Staff
- General Considerations for Animal Studies for Cardiovascular Devices – Guidance for Industry and FDA Staff
- Guidance for the Non‐Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff
- Impact-Resistant Lenses: Questions and Answers: Guidance for Industry and FDA Staff
- Addition of URLs to Electronic Product Labeling: Guidance for Industry and FDA Staff
- The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13: Guidance for Industry, MQSA Inspectors and FDA Staff
- Blood Lancet Labeling – Guidance for Industry and Food and Drug Administration Staff
How to comment on these guidance lists or a specific guidance
CDRH would appreciate comments on any or all the guidance documents on the three lists. Specifically, CDRH is seeking comments on the relative priority of guidance documents. Comments could also include:
- Draft language on the proposed A-list and B-list topics
- Reasons the guidance is needed
- Proposed policy or information for FDA to consider on the topic
- Suggestions for new or different guidance documents. CDRH requests that stakeholders state the potential guidance topic in their comments.
For the retrospective review list, CDRH is seeking suggestions regarding which final guidances should be revised or withdrawn to help inform its retrospective review of existing final guidances. If a recommendation is made to withdraw or request a modification to an existing guidance document, CDRH requests that commenters also include information regarding why the guidance document should be revised or withdrawn and, if applicable, how it should be revised.
CDRH also welcomes any additional feedback for improving the guidance program and the quality of its 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 stakeholder needs are met.
You may 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 2020 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 2020 Proposed Guidance Development.”
