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Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

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.

Brexit Agreement: Reset your clocks!

EMERGO SUMMARY OF KEY POINTS:

  • European and UK negotiators strike a deal
  • Transitional period until 31 December 2020: 21 months extra
  • The MDR will apply in the UK; it is likely this will also happen for the IVDR
  • A mutual agreement would enable movement of medical devices between the UK and EU, but whether this is politically achievable remains unknown

中国FDA重组:对于医疗器械注册者的影响。

Emergo重点摘要:

  • 中国国家食品药品监督管理总局(CFDA)正在重组为国家药品监督管理局(CDA)。
  • 新的国家市场监督管理总局将从国务院接手对于国家药品监督管理局(CDA)的管理。
  • Emergo的咨询顾问正在确定中国的监管机构是否以及将会如何对医疗器械注册登记者造成影响。

China FDA Reorganization: Impact for medical device registrants

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) is being reorganized into the China Drug Administration (CDA).
  • A new State Administration for Market Supervision take over management of CDA from the Chinese State Council.
  • Emergo consultants are still determining whether and how the Chinese regulatory reorganization will affect medical device registrants.

收到FDA拒绝受理(RTA)您的510(k)注册申请的五个理由

Emergo重点摘要:

  • 如果FDA 510(k)申请人提交的申请未完成,可能会收到拒绝受理(RTA)信函,延误其医疗器械的审批手续。
  • 符合RTA筛选标准可以帮助医疗器械注册申请人避免收到来自FDA审查人员的RTA信函。
  • 在提交510(k)申请之前,利用FDA预申请(Pre-Sub)计划应该也能将由RTA问题引起的审批时间拖延风险最小化。

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.