United States Blog Posts

US FDA Proposes Expanding Abbreviated 510(k) Program for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has proposed expanding its Abbreviated 510(k) Program for medical devices utilizing well-understood technologies.
  • Expanding the abbreviated premarket notification pathway would provide faster US market access for some devices and streamline FDA review activities.
  • FDA plans to issue additional guidance on program criteria in the coming months.
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US FDA Preps Enhancements to Global Unique Device Identification Database (GUDID)

EMERGO SUMMARY OF KEY POINTS:

  • US FDA will release Global Unique Device Identification Database (GUDID) information including premarket submission and supplement numbers to the public in summer 2018.
  • Medical device registrants should familiarize themselves with FDA plans and review their own confidentiality designations immediately.
  • FDA will begin releasing GUDID data to the public in June 2018.
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Here Come the Exoskeletons

My colleagues and I are excited by the current value and future potential of exoskeletons in healthcare. Applications of particular interest are the accommodation and treatment of partial paralysis and other types of musculoskeletal impairments, some of which are caused by a stroke.

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FDA Delays Post-market Safety Reporting Requirements for Combination Products

EMERGO SUMMARY OF KEY POINTS:

  • Postponed FDA enforcement of post-market safety reporting rules (PMSR) for combination products
  • Delay allows combination product applicants more time to implement appropriate reporting and recordkeeping systems and procedures
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Five Reasons for Receiving an FDA Refuse-to-Accept (RTA) Decision on your 510(k) Registration

EMERGO SUMMARY OF KEY POINTS:

  • FDA 510(k) applicants may receive Refuse to Accept (RTA) letters if their submissions are not complete, delaying their medical device clearance reviews.
  • Meeting RTA screening criteria can help medical device registrants avoid receiving RTA letters from FDA reviewers.
  • Utilizing the FDA Pre-Submission (Pre-Sub) program prior to submitting 510(k) applications may also minimize the risk of clearance delays due to RTA issues.
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AAMI Webinar on HFE Reports for Medical Device Manufacturers

A new webinar hosted by the Association for the Advancement of Medical Instruments (AAMI) will provide insights into preparing Human Factors Engineering (HFE) test plans and reports that existing regulatory guidance does not fully address.

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FDA: GUDID Data Primarily from Class II and Implantable Medical Devices (So Far)

EMERGO SUMMARY OF KEY POINTS:

  • The FDA GUDID database now has more than 1.6 million records of medical devices registered for sale in the US.
  • Most GUDID data is from Class II devices, and almost half of GUDID records cover implantable devices.
  • So far, orthopedic devices account for 35% of GUDID device records.
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US FDA Rolling Out Updates to UDI Database in 2018

EMERGO SUMMARY OF KEY POINTS:

  • US FDA plans updates to its Global Unique Device Identification Database (GUDID) for Spring and Summer 2018.
  • GUDID updates include new file data elements, record accessibility and premarket submission and supplement number requirements.
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FDA Updates PMA and 510(k) Refuse to Accept Policy for Combination Products

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated its 510(k) Refuse to Accept and Premarket Approval acceptance policies for combination product submissions.
  • The updated guidances include new requirements for drug patent and exclusivity information.
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In Brief: US Legislators Put Medical Device Tax Back on Ice

US lawmakers have delayed reestablishing the Medical Device Excise Tax (MDET) by another two years as part of a short-term government funding arrangement.

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