Worldwide Medical Device 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.

US FDA Lists Reimbursers Interested in Attending Pre-Sub Meetings for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • The FDA has signed up seven insurers and health technology assessment (HTA) organizations to participate in pre-submission meetings with medicla device clinical trial sponsors upon request.
  • US regulators believe that involving reimbursement providers earlier in premarket authorization will give device companies a clearer idea of how their products will be covered after commercialization.
  • The FDA states that although reimbursers may participate in pre-sub meetings, device safety and effectiveness issues will remain paramount in determining whether and how clinical trials occur.

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Preparing for an FDA QSR Inspection: Do’s, Don’t and Maybe’s

EMERGO SUMMARY OF KEY POINTS:

  • FDA Quality System Regulation (QSR) inspections occur on an unannounced, “surprise” basis.
  • FDA quality inspection methods and approaches are laid out in the Quality System Inspection Technique (QSIT) guidelines.
  • Manufacturers should conduct internal audits of their quality systems on a regular basis to ensure 21 CFR Part 820 compliance and address any issues before an actual FDA inspection occurs.

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US Issues Final Rules for Clinical Trial Information Reporting

EMERGO SUMMARY OF KEY POINTS:

  • A final rule from the US Department of Health and Human Services (HHS) expands clinical trial reporting requirements to the ClinicalTrials.gov website.
  • To complement the HHS rule, the National Institutes of Health (NIH) is also increasing clinical trial reporting requirements for medical device and drug studies it funds.
  • The HHS final rule is effective in January 2017.

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Chinese FDA Adds to Medical Device Submission Document Requirements

EMERGO SUMMARY OF KEY POINTS:

  • Chinese market authorization applicants will have to submit hard and soft copies of their registration applications to regulators, plus declarations of consistency.
  • New documentation rules will be effective in November 2016.

Read more about Chinese FDA Adds to Medical Device Submission Document Requirements...

NEST Update: Recommendations for Early-Phase Projects of US Medical Device Evaluation System

EMERGO SUMMARY OF KEY POINTS:

  • The FDA and other stakeholders are moving forward incrementally with their National Evaluation System for health Technology (NEST).
  • NEST managing boardmembers recommend demonstration projects as early-stage activities of the NEST program.
  • Recommended early-stage NEST projects focus on pre-and post-market evidence evaluations.

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Australian Government Accepts Proposals for Multiple Market Pathways for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • The Australian Department of Health has accepted expert panel recommendations to establish multiple market pathways for medical device registrants.
  • Expedited approvals and Therapeutic Goods Administration recognition of market authorizations from foreign regulators are included in the recommendations.
  • The Australian government plans to begin implementing regulatory reforms in 2016 and 2017.
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European Medical Device Regulatory News You May have Missed

EMERGO SUMMARY OF KEY POINTS:

  • We analyze draft Medical Device and IVD Regulations that will replace current Medical Device Directives in Europe over the coming years.
  • Ramifications of Brexit on how and whether CE Marking will continue to be used in the UK are not yet clear.
  • A new MEDDEV updates clinical evaluation report (CER) recommendations in Europe.

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FDA Adjusts 510(k) Third Party Review Program Ahead of MDSAP

EMERGO SUMMARY OF KEY POINTS:

  • FDA draft guidance clarifies how Third Party Review process aligns with the Medical Device Single Audit Program (MDSAP).
  • This guidance complements several IMDRF MDSAP documents issued in 2013, 2014 and 2015.
  • MDSAP implementation set for January 2017; US, Australia, Brazil, Canada and Japan are participating.

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MDSAP Authorities Push for Medical Device Industry Participation

Officials overseeing the Medical Device Single Audit Program (MDSAP) developed to allow single quality system audits across multiple regulatory jurisdictions have issued an official request for participation to medical device manufacturers ahead of the program’s full implementation deadline.

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FDA Pushes Back UDI Deadline for Convenience Kit and Repackaged Device Labelers

Medical device regulators at the US Food and Drug Administration have notified labelers of some Class II devices that their deadline for Unique Device Identification (UDI) compliance has been extended to September 2018.

Read more about FDA Pushes Back UDI Deadline for Convenience Kit and Repackaged Device Labelers...

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