2 min reading time

CDRH published a list of guidance documents it is considering in fiscal year 2017. These include:

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Draft Guidance Topics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

The full CDRH statement available at http://bit.ly/CDRH-FY17

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Discussions

Any tips on growing relationships with potential distributors?
http://bit.ly/dist-tips

Breaking into the medical sales industry
http://bit.ly/brkg-in

Is 60601-1 mandatory in the USA?
http://bit.ly/6060man

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. We’re hosting our free webinar tomorrow on Advanced Product Registration Techniques for Faster Global Access. Register at http://medgroup.biz/mktaccess

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Julie Omohundro
Principal Consultant at Class Three, LLC
Lakshman, this web page has a link where you can sign up to receive emails when new CDRH guidances are published:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

Lakshman Srinivasan
Retired
Thank you for alerting us. If you do know when they actually post these docs, please alert us again. I am sure all this takes a lot of work on your part – much appreciated.

Alessandro Mazzarisi
Senior Technician, Storyteller, Linkedin Contributor
Thank you very much Joe.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Mark, you made my day. Thank you for the kind note.

Mark Proulx
Quality and Remediation Rock Star
Hey Joe Hage, good stuff. Thanks for keeping us abreast of these developments. I can see at least a few of these that would directly affect my clients, so I can let them know to look for these in future. I find your updates to be the definitive source for keeping on top of the agency and current events.