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CDRH’s Guidance Goals for 2017


Posted in Regulatory and Compliance by mthibault on December 29, 2016

The Center publishes its priorities for draft and final guidance subjects in the coming year.


Marie Thibault

CDRH has publicized its resolution list for the new year, issuing an A-list of its top priorities for final and draft guidance in fiscal year 2017

On the list of top subjects to tackle are 12 final guidance topics and four draft guidance topics.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 These older guidances are expected to be reviewed with an eye to whether any of them should be revisited or withdrawn.

Hear FDA's Rochelle Fink explain "How FDA/CMS Parallel Review Can Work for You" at MD&M West in Anaheim, Feb. 7-9, 2017.

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 The draft guidance topic on Medical Device Decision Support Software (also called Clinical Decision Support Software), a topic that was part of the FY2015 and FY2016 lists. CDRH has not yet published draft guidance on the topic and its plans to do so may have been impacted by The 21st Century Cures Act, which was signed into law this month.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:

  1. FDA’s risk stratification and delineation of regulated versus unregulated CDS software
  2. FDA’s plans to apply the concept of “transparent” software
  3. 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”

Marie Thibault is the managing editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @MedTechMarie.

[Image courtesy of ANNCA/PIXABAY]


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Getting a head start

As noted the #1 item on the list of 12/27 is Postmarket Management of Cybersecurity in Medical Devices. This was actually released on 12/28. #2, Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types, was released on 12/30.A good way to reach your goals is to have some goals already completed before you put it on your list of goals.