United States Blog Posts

US FDA Recognizes ISO 18562 Biocompatibility Standard for Medical Devices

Medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have officially recognized a series of ISO standards for volatile organic compounds (VOC) and particle testing as consensus standards.

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US FDA Maps Out Pre-Submission Meeting Options for Medical Device Applicants

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated guidance on how to utilize its Q-Submission Program for medical device manufacturers before they submit premarket applications.
  • Following MDUFA IV, FDA has revised scheduling and timeframe processes for the Q-Sub program.
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New US FDA Recommendations for Non-Clinical Bench Performance Test Submissions

EMERGO SUMMARY OF KEY POINTS:

  • US FDA issues recommendations for premarket test submissions regarding specific descriptions, inclusions, format, and report types.
  • Recommendations include structured outlines that encapsulate test motives that are to be included with each required Summary Report submission.
  • Specific FDA recommendations cover content and organization of complete Test Reports from overall description through conclusion.
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US Regulators Plan Class II Reclassification of Diagnostic Imaging Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA plans down-classification of some diagnostic imaging devices for radiological applications.
  • Targeted devices would move from Class III (high risk) to Class II (moderate risk).
  • Affected devices would undergo 510(k) and special controls premarket review.
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US FDA Attempts to Spur Development of Medical Devices Targeting Opioid Addiction

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has launched a new program to fast-track development and market authorization of devices for treating opioid addiction and pain management.
  • Manufacturers have  until September 30, 2018 to submit applications to participate in the program.
  • Accepted manufacturers’ devices and technologies will undergo expedited premarket review.
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US FDA: No Additional Regulations for Medical Device OEMs and Third-party Service Providers

EMERGO SUMMARY OF KEY POINTS:

  • US FDA issues a required report on the continued quality, safety, and effectiveness of medical device servicing.
  • Evidence is insufficient to determine whether additional regulations are necessary for OEMs and third-party service companies.
  • The FDA proposes additional actions based on the report’s findings.
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Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

EMERGO SUMMARY OF KEY POINTS:

  • US FDA is considering adoption of ISO 13485:2016 quality system requirements for medical device registrants.
  • ISO 13485 would replace FDA Quality System Regulations (QSR) according to proposed rules.
  • FDA alignment to ISO 13485 quality principles would align the US market pathway more closely to other major device markets.
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US FDA Clarifies Policy on Multiple-Function Medical Device Oversight

EMERGO SUMMARY OF KEY POINTS:

  • New guidance explains FDA approach to multiple-function products that feature device and non-device components.
  • FDA may assess non-device components of a multi-function product to determine their impact on the safety and effectiveness of the product’s features that do meet the definition of a medical device.
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US Regulators Propose Expanded Medical Device Cybersecurity Approach

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has proposed various measures to boost cybersecurity risk mitigation in a new Medical Device Safety Action Plan.
  • The agency has also proposed merging pre- and post-market units of its Center for Devices and Radiological Health (CDRH) division.
  • A proposed new Cybermed Safety (Expert) Analysis Board would coordinate cybersecurity risk management efforts between industry and FDA, according to the new plan.
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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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