Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium
« Back to Previous Page
like 5 comments  share
Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
January 2017
Guidance documents CDRH intends to issue or develop in 2017
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Draft Guidance Topics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

++++++++++

Discussions

Any tips on growing relationships with potential distributors?

Breaking into the medical sales industry

Is 60601-1 mandatory in the USA?

++++++++++

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


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.

Marked as spam
Posted by Joe Hage
Asked on January 31, 2017 11:17 pm
45 views
  • Follow
  • Unfollow
  • Report spam
like 5 comments  share

Meet your next client here. Join our medical devices group community.

« Back to Previous Page
Ask a Question
Leave a Comment

We still use LinkedIn to access our site because it’s the only way to “pull in” your LinkedIn photo, name, and hyperlink to your profile page, all vital in building your professional network. When you log in using LinkedIn, you are giving LinkedIn your password, not me. I never see nor store your LinkedIn credentials.

Stay connected with us.

By signing up you are agreeing to our Privacy Policy.

Categories

  • Capital/Investment
    • Business Model
    • Funding
  • Careers
  • Design/Devel
    • Design
    • Development
    • Human Factors
    • Labeling
    • Material Selection
    • R&D
    • Trials and Post-Market
  • Featured
  • Industry
    • Announcements
    • Device Tax
    • Hospital and Health Care
    • Innovation
    • Medtech
  • LinkedIn, etc.
  • Markets
    • Africa
    • Americas
    • Asia
    • Australia
    • Europe
  • Regulating
    • CE Marking
    • EU
    • FDA
    • FDA/EU etc.
    • Notified Bodies
    • Quality
    • Regulatory
  • Selling
    • Distribution
    • Intellectual Property
    • Marketing/Sales
    • Reimbursement
  • Worth bookmarking!
Feature your job here.
logo

Companion to LinkedIn's 350,000 member community

  • Contact
  • Medical Device Marketing
  • In Memoriam
  • Medical Device Conference

The Medical Devices Group   |   Copyright © 2025 Terms, Conditions & Privacy

Medical Devices Group
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Strictly Necessary Cookies

Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.