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Medical Devices

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Documents the Center for Devices and Radiological Health is Considering for Development (FY10)

Introduction

This is the list of guidance documents CDRH is considering for development this year (2010). 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 on the CDRH Guidance Document page.

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 2010 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 2010?

CDRH is considering developing a variety of guidance documents in fiscal year 2010:

Specific topics are listed below:

Guidance Related to FDAAA or General Premarket Issues 

  • 30-Day Notices and 135-day PMA Supplements
  • 510(k) Modifications
  • 510(k) Paradigm
  • Actions on 510(k) Submissions
  • Annual Reports for PMAs
  • Assay Migration Studies for IVDs
  • Biocompatibility
  • Good Laboratory Practices
  • Humanitarian Device Exemption (HDE) - Q & A
  • Live Case Presentations During IDE Clinical Trials
  • Premarket Review of Devices Labeled for Home Use
  • Protocol Review Guidance for IVD's
  • Requests for Information Under Section 513(g)
  • Section 513(g) Fees & Refunds
  • Use of nanoscale materials in medical devices

Guidance on Postmarket and Compliance Issues

  • Adverse Event Reporting for IVD's
  • Commercially Distributed Research Use Only and Investigational Use Only IVD Products: FAQs
  • Medical Device Reporting for Manufacturers
  • Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act

Device Specific Guidances

  • Assessment of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)
  • Assessment of Methicillin-resistant Staphylococcus aureus (MRSA) using nucleic acid-based IVD’s
  • Bacillus spp. Serological Reagents
  • Benign Prostatic Hyperplasia (BPH) Devices: Preclinical and Clinical Recommendations
  • Cardiovascular (Pericardial) Patches
  • Cervical pillows for the treatment of obstructive sleep apnea
  • Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data
  • Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
  • Contact Lens Care Products
  • Coronary Drug Eluting Stents
  • Dental Mouthguards
  • ECG Electrodes
  • Impact-resistant Lenses
  • Infusion pump guidance
  • Invasive Portable Blood Glucose Monitoring Systems
  • IVDs for Detection and Differentiation of Influenza Virus
  • Points to Consider for In vitro Diagnostic Home-use Prothrombin Time Devices
  • Review Criteria for Assessment of Lyme Disease
  • Special Control Guidance Document: Ovarian Adnexal Mass Assessment Score Test System
  • Recommendations for hCG Pregnancy Tests
  • Urinary Incontinence Clinical Trials

Global Harmonization or Standards Related Guidances

  • Application of IEC 60601-1 Third Edition in Premarket Applications
  • Characterizing the Significance of Quality Management System Deficiencies - addressing GHTF/SG1
  • Essential Principles of Safety and Performance - addressing GHTF/SG1/N041:2005
  • ISO14155 Adoption for Clinical Device Trials
  • Quality Management System for management of procured products, outsourced processes and their suppliers - addressing GHTF/SG3/N17
  • Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Addressing GHTF/SG4/N28R4:2008, GHTF/SG4/N30R20:2006, and GHTF/SG4/N33R16:2007
  • Risk Management Information in Premarket Submissions
  • Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles - addressing GHTF/SG1/PD/N0011
  • Use of the IEC standard(s) for ultrasound therapy systems in lieu of older BRH mandatory standard

Cross-Cutting, Process, and Other Guidances

  • Bayesean Statistics
  • IVD Studies – FAQ
  • Genotoxicity testing for pre-clinical safety evaluation of medical devices and device materials
  • LASIK Patient Labeling
  • Radio-Frequency Wireless Technology in Medical Devices
  • Review Practices for Instruments for In Vitro Diagnostic Devices
    
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