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MDUFMA > Documents the Center for Devices and Radiological Health is Considering for Development (FY08)
Documents the Center for Devices and Radiological Health is Considering for Development (FY08)
Introduction
On October 10, 2007, 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 2008. The Notice also advised the public of the establishment of a public docket to which comments may be submitted. (42 FR 57587)
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 2007N-0357. Comments may include draft language on the proposed topics and/or suggestions for new or different guidance documents. CDRH hopes this docket will become 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.
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 the 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 cannot 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 2007N-0357 for comments on any or all of the proposed fiscal year 2008 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 hopes this docket will become an important tool for receiving information from interested parties and for making information available to the public.
Interested persons may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 2007N-0357. 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 2008?
CDRH is considering developing a variety of guidance documents in fiscal year 2008:
Specific topics are listed below:
Guidance related to MDUFMA reauthorization:
- 30-Day Notices and 135-Day PMA Supplements
- FDA and Industry Actions on Premarket Approval Applications
- FDA and Industry Actions on Premarket Notification Submissions
- Assay Migration Studies for IVDs
- Clinical Trials Using De-identified Leftover Samples
- Electronic Registration and Listing
- Enterovirus Assays
- Expedited Review of Premarket Submissions
- Interactive Review
- IVDs for Detection and Differentiation of Influenza Viruses
- Pediatric HDEs – guidance for IRBs
- Pre-PMA and pre-IDE Meetings
- Requests for Information under Section 513(g)
- Small Business Qualification and Certification
- Third Party Inspection Program
Guidances on Postmarket Issues
- Adverse Event Reporting for In Vitro Diagnostic Devices
- Annual Reports for PMAs
- Electronic MDR reporting
- Event Problem Code Changes
- Manufacturing Site Change Supplements
- Radiation Safety Considerations for Hand Held X-Ray Equipment
- Regulatory Requirements for Foreign and Domestic Dental Laboratories
- Surveillance and Detention without Physical Examination of Gloves
- Surveillance and Detention without Physical Examination of Condoms
Device Specific Guidances
- Absorbable Hemostatic Devices
- Bacillus spp. Assays
- Bone Sonometers
- Blood Glucose Portable Invasive Monitoring Systems
- Coronary Drug Eluting Stents
- Dental Bone Grafting Materials
- Diagnostic Ultrasound Systems and Transducers
- Electrocardiograph Electrodes
- Electroconvulsive Therapy Devices
- Esophogeal and Tracheal Prostheses
- Full Field Digital Mammography Systems
- HCG (Human Chorionic Gonadotropin) Tests
- Hemodialysis Blood Tubing Sets
- Hip Joint Replacement Systems – clinical studies
- IVD Multivariate Index Assays
- Impact Resistant Lenses – Q&A
- Male Condoms Made of Natural Rubber Latex – labeling
- Magnetic Resonance Imaging systems – device compatibility
- Nocturnal Emodialysis Systems - IDEs
- Permanent Pacemaker Leads and Adapters
- Plasmodium Species Antigen Detection Assays
- Powered Muscle Stimulators
- Powered Wheelchairs and 3-Wheel Vehicles
- PTCA (Percutaneous Transluminal Coronary Angioplasty) Devices
- Pulse Oximeters
- Replacement Heart Valves
- Retina Prostheses – preclinical and clinical studies
- Stereotaxic Devices
- Surgical Ablation Treatment of Atrial Fibrillation – clinical studies
- Tissue Adhesives for the Topical Approximation of Skin
- Tissue Expanders
- Topical Oxygen Chamber for Extremities
- Total Artificial Discs - IDEs
- Transcutaneous Electrical Nerve Stimulators
- Urinary Incontinence Devices – clinical studies
- Vascular Prostheses
- Women in Cardiovascular Device Studies
- Zonisamide and Lamotrigine Assays
Standards Related Guidances
-
Global Harmonization Task Force Study Group Documents
- Summary Technical Documentation for Demonstrating Conformity of IVDs to the Essential Principles of Safety and Performance
- Use of IEC 60601-Third Edition in submissions
- Use of IEC Ultrasound Physiotherapy Standards
Cross-Cutting and Process Guidances
- 510(k) Paradigm
- Bayesian Statistics in Medical Device Clinical Trials
- CLIA Categorization Procedures
- CLIA Waiver Applications
- Computer-assisted Detection Devices for Radiological Images and Data
- Electronic Copies and Electronic Submissions of Data
- IVD Studies – General Guidance
- Modifications to PMA Devices
- Patient Labeling for Medical Devices
- Premarket Notifications for Devices that Include Antimicrobial Agents
- Reusable Medical Devices- Labeling for Reprocessing in Healthcare Facilities
- Review and Inspection of PMA Manufacturing Information
- Review and Inspection of PMAs under Bioresearch Monitoring Program
- Risk Management Information in Premarket Submissions
- Sterility information in Premarket Notifications
Updated October 10, 2007
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