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The Center publishes its priorities for draft and final guidance subjects in the coming year.
Marie Thibault
December 29, 2016
5 Min Read
CDRH has publicized its resolution list for the new year, issuing an A-list of its top priorities for final and draft guidance in fiscal year 2017.
On the list of top subjects to tackle are 12 final guidance topics and four draft guidance topics. These include final guidance on titles like "510(k) Third Party Review Program" and "Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices," as well as both draft and final guidance on "New or revised procedural guidances for MDUFA IV implementation," among others.
CDRH also published a B-list of topics that it hopes to issue if possible, as well as a links to final guidance documents from 1977, 1987, 1997, and 2007. These older guidances are expected to be reviewed with an eye to whether any of them should be revisited or withdrawn.
One key issue missing from CDRH's A-list this year? The draft guidance topic on Medical Device Decision Support Software (also called Clinical Decision Support Software), a topic that was part of the FY2015 and FY2016 lists. CDRH has not yet published draft guidance on the topic and its plans to do so may have been impacted by The 21st Century Cures Act, which was signed into law this month.
Section 3060 of the 21st Century Cures Act is focused on regulation of medical software and outlines five low-risk categories of medical software that will fall outside of FDA regulation, barring any safety concerns.
Brad Thompson, JD, MBA, general counsel of the Clinical Decision Support (CDS) Coalition and a member of MD+DI's editorial advisory board, told MD+DI that in order to be regulated by FDA under The 21st Century Cures Act, CDS software cannot be "transparent." He explained in an email that "transparent" software would allow a physician to "see through the software to the underlying patient data and the clinical logic applied by the software, such that the physician is not required to rely on the software."
CDS Coalition hopes FDA will still address the guidance topic. Thompson outlined three key issues the group is looking for in such guidance:
FDA's risk stratification and delineation of regulated versus unregulated CDS software
FDA's plans to apply the concept of "transparent" software
FDA guidance on CDS software related to pharmaceuticals
"The guidance is more important now than ever before," Thompson wrote.
Otherwise, the Center did publish on almost all of its FY2016 A-list topics, except for two final guidance subjects--UDI Direct Marking, and Laboratory Developed Tests (LDT). FDA is reportedly delaying final guidance on oversight of LDTs in order to work with the incoming Trump administration.
In 2016, CDRH issued 34 final and 23 draft guidance documents. The Center has not slowed its pace at year end, publishing three final guidances--all listed on the FY2017 A-list--in the final week of December.
Here is CDRH's full A-list and B-list:
"Prioritized medical device guidance documents that the Agency intends to publish in FY 2017 ("A-list")
Final Guidance Topics
Postmarket Management of Cybersecurity in Medical Devices
Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions
Suggested Format for Developing and Responding to Deficiencies
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics
Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS) - Based In Vitro Diagnostics
Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
510(k) Third Party Review Program
New or revised procedural guidances for MDUFA IV implementation
Draft Guidance Topics
IDE Submission, Content, Organization, Interactions
Update to Section V Demonstrating Insignificant Risk of an Erroneous Result in the Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices guidance
Dual 510(k) and CLIA Waiver
New or revised procedural guidances for MDUFA IV implementation
Device guidance documents that the Agency intends to publish, as the Agency's guidance-development resources permit each in FY 2017 ("B-list")
Final Guidance Topics
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
Medical Device Development Tools (MDDT)
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
Unique Device Identification: Direct Marking of Devices
Technical Considerations for Additive Manufactured Devices
Draft Guidance Topics
Standard Content and Format for Patient Labeling of Medical Devices
Standard Content and Format for Healthcare Provider Labeling of Medical Devices
Patient Matched Instrumentation for Orthopedic Devices
Utilizing Simulated Animal Transplant Models to Evaluate the Safety of Perfusion-based Organ Preservation Devices
Strategy to Assess the Credibility of Computational Modeling Studies
Related Replacement Reagent and Instrument Policy
Unique Device Identification System: Defining the Labeler
Considerations to Support a Claim of Electromagnetic Compatibility for Medical Electrical Equipment and Medical Electrical Systems"
[Image courtesy of ANNCA/PIXABAY]
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