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Documents the Center for Devices and Radiological Health is Considering for Development (FY09)
Introduction
On September 30, 2008, FDA published a Notice in the Federal Register directing the public to the list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development in 2009. The Notice also advised the public of the location of a public docket to which comments may be submitted. (73 FR 56830)
This is the list of guidance documents CDRH is considering for development this year. CDRH plans to update this list every year. CDRH invites interested persons to submit comments on any or all of the guidance documents on the list to docket FDA-2007-N-0270. Comments may include draft language on the proposed topics and/or suggestions for new or different 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 list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CDRH has already issued Level 1 drafts that may be finalized following review of public comments. This list of proposed guidance documents is not binding. CDRH is not required to issue every guidance document on the list and may issue guidance documents not on the list.
Current FDA and CDRH guidance documents can be found at http://www.fda.gov/cdrh/guidance.html.
Why is CDRH posting a list of guidance documents it is considering for development?
During negotiations over the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA), FDA agreed to meet a variety of goals in return for additional funding from industry. The goals are quantitative and qualitative commitments intended to help get safe and effective medical devices to market more quickly. Among other things, FDA agreed to:
- annually post a list of the guidance documents FDA’s Center for Devices and Radiological Health (CDRH) is considering for development; and
- provide stakeholders an opportunity to provide comments and/or draft language for those topics as well as suggestions for new or different guidances.
Does CDRH expect to complete the list?
Our experience over the years has shown that there are many reasons CDRH staff does not complete the entire annual agenda of guidances it undertakes. Staff are frequently diverted from guidance development to other activities, including review of premarket submissions or postmarket problems. In addition, the Center is required each year to issue a number of guidances it 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 that indicate the relative priority of different guidance topics to interested stakeholders. In addition, we intend to consider stakeholder feedback to the docket to help us prioritize our allocation of resources to specific guidance topics on the list.
How do I comment on this list or a particular guidance document?
FDA has established docket FDA-2007-N-0270 for comments on any or all of the proposed fiscal year 2009 guidance documents. FDA invites interested persons to submit comments, draft language on the proposed topics, and/or suggestions for new or different guidance documents. FDA believes this docket is an important tool for receiving information from interested parties and for making information available to the public.
Interested persons may submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Identify comments with docket number FDA-2007-N-0270. You may see received comments in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
What guidance documents is CDRH considering for development during fiscal year 2009?
CDRH is considering developing a variety of guidance documents in fiscal year 2009:
Specific topics are listed below:
Guidance Related to FDAAA
- Assay Migration Studies for IVDs
- Clinical Trials Using De-identified Leftover Specimens
- Disputes Concerning Payment or Refund of Medical Device User Fees
- Electronic Registration and Listing
- FDA and Industry Actions on Premarket Notification Submissions
- Inspection by Accredited Persons
- Tracking Pediatric Device Approvals
- User Fees and Refunds for Premarket Notification Submissions
Guidance on Postmarket Issues
- Electronic Medical Device Reporting
- Manufacturing Site Change Supplements
- Precedence on Enforcement Action Determinations
Device Specific Guidances
- Absorbable Hemostatic Devices
- Antimicrobial Susceptibility Tests
- Bacillus spp. Serological Reagents
- C. Difficile
- CAD Devices for Radiology
- Cardiac Allograft Gene Expression Profiling Test System
- Cervical Pillows for Obstructive Sleep Apnea
- Computerized Clinical Device Trials
- Contact Lens Care Products
- Coronary Drug Eluting Stents
- Dental Amalgam
- Dental Bone Grafting Materials
- Dental Mouthguards
- ECG Electrodes
- Electroconvulsive Therapy Devices
- Esophageal and Tracheal Prosthesis
- Flexible Sterilization Packaging and Rigid Sterilization Containers
- Full Field Digital Mammography
- Germicides Used to Reprocess Reusable Hemodialysis Systems
- Guidance on Instruments (IVD)
- Heart Valves - IDE and PMA Applications
- Hip Joint Replacement Systems
- Home Prothrombin Time
- Human Metapneumovirus (hMPV) Nucleic Acid Assays
- Human Papilloma Virus
- IDEs for Symptomatic Uterine Fibroid Devices
- Impact Resistant Lenses
- Infusion Pumps
- Invasive Portable Blood Glucose Monitoring Systems
- IVDs for Detection and Differentiation of Influenza Virus
- LASIK Patient Labeling
- Leeches
- Maggots
- Neurocognitive Assessment for Cardiovascualr Devices
- Nucleic Acid Assay for Detection and Differentiation of Influenza A Virus Subtypes
- Nucleic Acid Amplification Assays for the Detection of Enterovirus RNA
- Over the Counter (OTC) One-lead Electrocardiography (ECG) Devices
- Oxygen Regulators and Oxygen Conserving Devices
- Pacemaker Lead Adaptor 510(k) Submissions
- Pacing Leads
- Powered Muscle Stimulators
- Powered Wheelchairs
- PTCA (Percutaneous Transluminal Coronary Angioplasty) Devices
- Pulse Oximeters Submissions
- Radio-Frequency Wireless Technology in Medical Devices
- Respiratory Viral Panel Multiplex Nucleic Acid Assay
- Retina Prostheses – Preclinical and Clinical Studies
- Stereotaxic Devices
- Surgical Ablation Treatment of Atrial Fibrillation – clinical studies
- Therapeutic Drug Monitoring
- Tissue Expander
- Topical Oxygen Chamber for Extremities
- Vascular Grafts
Standards Related Guidances
- Use of IEC 60601-1 Third Edition in Applications
- Use of IEC Standard(s) for Ultrasound Therapy Systems
- Use of ISO 13485 Audits
- Use of ISO 14155 in Clinical Device Trials
Cross-Cutting and Process Guidance
- 510(k) Paradigm
- Adverse Event Reporting for IVDs
- Annual Reports for PMAs
- Bayesean Statistics
- CDRH Enforcement Discretion
- Electronic Premarket Statistical Data Submissions to CDRH
- Exports - General Guidance
- IVD Studies - General Guidance
- Live Case Presentations During IDE Clinical Trials
- Medical Devices that Include Antimicrobial Agents
- Modifications to PMA Devices
- Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens
- Preamendment Status Determination
- Pre-IDE guidance for IVDs
- Premarket Review of Devices Labeled for Home Use
- Requests for Information Under Section 513(g)
- Research Use Only - General Guidance
- Reusable Medical Devices- Labeling for Reprocessing in Healthcare Facilities
- Risk Management Information in Premarket Submissions
- Sex Differences in Clinical Evaluation of Cardiovascular Devices
- Sterile Devices in Premarket Notification Submissions
- Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance
Updated October 3, 2008
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