Worldwide medical device QA/RA blog

News and commentary on regulatory changes.

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.

Changes to Australian Medical Device Recall Process Set for Early 2018

EMERGO SUMMARY OF KEY POINTS:

  • Updates to the Australian TGA’s medical device recall process will come into effect in January 2018.
  • The updated TGA recall process includes guidelines for determining recall versus non-recall actions.
  • TGA registrants should take advantage of a “familiarization period” between now and the recall updates’ effective date of January 15, 2018.
Read more about Changes to Australian Medical Device Recall Process Set for Early 2018...

New US FDA FAQ Clarifies De Novo Medical Device User Fee Requirements

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA has a new guidance out that includes a FAQ on MDUFA IV user fees and refund policies for de novo medical device premarket submissions.
  • Only de novo devices intended for pediatric applications and those submitted by government entities and not intended for commercialization will be exempt from user fees.
  • Because new user fees are substantial, de novo device applicants should carefully consider FDA policies described in the guidance.
Read more about New US FDA FAQ Clarifies De Novo Medical Device User Fee Requirements...

MDUFA IV: US FDA Sets Performance Goals for De Novo Medical Device Reviews

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has published performance goals for handling de novo medical device submissions.
  • De novo user fees and performance goals were established under the Medical Device User Fee Amendments of 2017 (MDUFA IV).
  • FDA has set a 150-day timeframe for review of de novo applications.
Read more about MDUFA IV: US FDA Sets Performance Goals for De Novo Medical Device Reviews...

IMDRF Pushes Wider Use of Registry Data in Medical Device Regulatory Decisions

EMERGO SUMMARY OF KEY POINTS:

  • The International Medical Device Regulators Forum (IMDRF) has opened a public consultation on recommendations for assessing usability of medical device registry data by regulatory agencies.
  • IMDRF identifies four key factors agencies should consider when determining the usability of a device registry’s data in making regulatory decisions.
  • IMDRF is accepting comment on its proposal until December 1, 2017.
Read more about IMDRF Pushes Wider Use of Registry Data in Medical Device Regulatory Decisions ...

US FDA Updates Guidance on Premarket Review Appeals and Deficiency Letters

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated guidances on its premarket review appeals process and for market application deficiency letters.
  • The agency has more clearly defined terms including “significant decision” and “substantive summary” for medical device market applicants appealing regulatory decisions.
  • The agency has provided clearer recommendations for responding to deficiencies in premarket applications, as well.
Read more about US FDA Updates Guidance on Premarket Review Appeals and Deficiency Letters...

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.
Read more about FDA Lines Up Participants for Pre-Cert Digital Health Technology Pilot ...

Brazilian Regulators Shaking Up BGMP Certification Process for Higher-risk Devices

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA plans major changes to BGMP certification requirements for many higher-risk medical devices.
  • Class III and IV medical device registrants will undergo “desktop reviews” rather than onsite inspections for BGMP certification.
  • ANVISA will also implement a risk-based quality system inspection approach prioritizing higher-risk device manufacturers.
Read more about Brazilian Regulators Shaking Up BGMP Certification Process for Higher-risk Devices ...

Saudi Arabian Regulators May Exempt Some Low-Risk Medical Devices from MDMA Registration

EMERGO SUMMARY OF KEY POINTS:

  • Saudi medical device regulators have unofficially indicated they may soon exempt certain Class I devices from MDMA registration requirements.
  • Class I non-sterile, non-measuring devices would still require Saudi Arabia Authorized Representation in order to be commercialized in the country.
  • The Saudi Food and Drug Authority (SFDA) may push through the new exemption in the next month or two.
Read more about Saudi Arabian Regulators May Exempt Some Low-Risk Medical Devices from MDMA Registration...

UK, European Device Industries Urge Continued Regulatory Alignment Post-Brexit

EMERGO SUMMARY OF KEY POINTS:

  • UK and European medical device and IVD industry trade groups are arguing for full MDR and IVDR implementation in Great Britain during and after Brexit negotiations.
  • The groups seek European recognition of UK Notified Bodies and Authorized Representatives as well as full access to the Eudamed database by the UK MHRA.
  • Whether Brexit negotiators adequately address the trade groups’ concerns remains an open question.
Read more about UK, European Device Industries Urge Continued Regulatory Alignment Post-Brexit...

US FDA Explainer: Microneedling Products as Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • New US FDA guidance explains factors for determining if a microneedling product meets the definition of a medical device.
  • Microneedling devices sold in the US typically lack predicate devices, making FDA classification of these products difficult.
  • FDA encourages mirconeedling device manufacturers to pursue de novo registration if their devices are considered medical devices.
Read more about US FDA Explainer: Microneedling Products as Medical Devices...

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