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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.

FDA Lines Up Participants for Pre-Cert Digital Health Technology Pilot

EMERGO SUMMARY OF KEY POINTS

  • The US FDA has identified nine participants in its digital health technology and software precertification pilot program.
  • FDA Pre-Cert pilot participants include firms such as Apple, Samsung, Fitbit and Johnson & Johnson.
  • The FDA will provide periodic Pre-Cert pilot updates as well as a public workshop in early 2018.

Medical Device Cybersecurity Legislation Advances in US Congress

EMERGO SUMMARY OF KEY POINTS:

  • New legislation introduced in the US House of Representatives would launch a working group headed by the FDA to develop strategies for mitigating cybersecurity risks in medical technology.
  • The proposed legislation builds on recommendations issued by the Health Care Industry Cybersecurity Task Force earlier in 2017.
  • If passed by the full Congress, the legislation would require the FDA-led working group to report on its efforts within 18 months.

Encryption, FIPS 140 and Medical Devices: Frequently Asked Questions

EMERGO SUMMARY OF KEY POINTS:

  • Pressure from US regulators and healthcare purchasing organizations for medical devices to demonstrate adequate encryption capabilities is increasing.
  • Compliance with the Federal Information Publications Standard (FIPS) 140-2 standard enables manufacturers to demonstrate adequate encryption tools for their devices.
  • FIPS 140-2 compliance is best addressed early in the medical device design phase.

Designing Effective Warnings for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Medical device warnings require careful design and communication considerations.
  • Manufacturers should heed warning sign conventions such as signal words.
  • Warnings are not foolproof, but are a necessary component for medical device risk mitigation.

Some people believe that warnings are useless; printed on medical devices only to offer legal protection. Indeed, manufacturers can and have been held liable for the “failure to warn,” and adding warnings neutralizes this claim.

European Internet of Things Cybersecurity Recommendations: Impact for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • European regulators have published high-level cybersecurity recommendations for industries including medical devices involved in the Internet of Things (IoT) paradigm.
  • The recommendations are partially intended to help companies meet upcoming European data privacy requirements under the General Data Protection Regulation, or GDPR.
  • The European report cites US FDA guidance regarding medical device cybersecurity principles and recommendations.

Brexit: The Hard Reality of “No Deal” for the Medical Device Industry

EMERGO SUMMARY OF KEY POINTS:

  • All economic operators in Europe, the UK and in the rest of the world may face significant consequences of Brexit.
  • The distribution network of medical devices currently placed on the market by UK based importers must be reviewed.
  • EU distributors currently placing UK manufactured devices on the market may have a different role.
  • Unless a fitting deal has been made, all certificates issued by British Notified Bodies on EU regulations/directives will become void from 30 March 2019.
  • Notified Bodies are already anticipating this scenario.

英国脱欧:医疗器械行业“没达成协议”的残酷现实

Emergo重点摘要:

  • 欧洲、英国和世界其他地区的所有经济运营者都将面临英国脱欧所带来的重大影响。
  • 我们需要对目前由英国通过进口商投放到市场上的医疗器械经销网络重新进行审视。
  • 目前将英国制造商的医疗器械投放到市场上的欧盟经销商们可能要开始扮演一个不同的角色。
  • 除非达成合适的协议,否则由英国公证机构根据欧盟监管法规/指令签发的所有证书从2019年3月开始就将失效。
  • 公证机构已经预期这种情景将会发生。