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Global Medical Device News

United States | In-Vitro Diagnostic Devices, Medical Devices

In Brief: US FDA Modifies List of Recognized Standards for Medical Device Premarket Reviews

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated its list of Recognized Consensus Standards for use in medical device premarket submissions.
  • FDA’s latest round of modifications and additions to the list cover orthopedic, materials, IVD and other medical device areas.

The US Food and Drug Administration’s latest changes and additions to its list of Recognized Consensus Standards for medical devices affect primarily orthopedic, IVD and materials areas as well as several other device categories.

FDA’s new...

Source | Stewart Eisenhart
Oct 22, 2018
United States | Medical Devices

Now Open: Emergo by UL HFR&D Chicago Studio

On October 11, EMERGO by UL Human Factors Research & Design (HFR&D) hosted an open house for clients, the Chicago tech start-up community, and employees to formally open its new Chicago Studio.

The event was highlighted by a keynote presentation from UL’s Chief Marketing Officer Kathy Seegebrecht, plus visits from colleagues from our Boston and UK offices, including Richard Featherstone from newly-acquired Medical Device Usability in Cambridge, UK.

UL LLC acquired Wiklund Research & Design (based in the USA) in 2012. Under Michael Wiklund’s stewardship...

Source | Mark Tavano
Oct 22, 2018
United States | Medical Devices

Emergo by UL Human Factors Research & Design Presents at Pre-filled Syringes & Injection Devices Conference

Allison Strochlic, Research Director of Emergo by UL’s Human Factors Research & Design (HFR&D) team, delivered two presentations at the 2018 PDA Universe Pre-filled Syringes & Injection Devices conference in Orlando, Florida.

Strochlic first discussed how to simulate stressful environments during usability tests of emergency-use products. The presentation included three specific case studies and audio and video clips demonstrating practical approaches to ensuring an appropriately high fidelity simulated use environment.

In addition, Strochlic...

Source | Allison Strochlic
Oct 22, 2018
United States | Medical Devices

US FDA Publishes Highly Anticipated Update to Medical Device Cybersecurity Recommendations

EMERGO SUMMARY OF KEY POINTS:

  • US FDA updates cybersecurity guidance first issued in 2014 for medical device premarket submissions.
  • The new guidance introduces a two-tier cybersecurity risk categorization system for devices.
  • The guidance also introduces the concept of a Cybersecurity Bill of Materials (CBOM) in lieu of a Software Bill of Materials (SBOM).

The US Food and Drug Administration has issued guidance updating medical device cybersecurity management requirements in premarket submissions from 2014.

The latest...

Source | Anura Fernando and Stewart Eisenhart
Oct 19, 2018
United States | Medical Devices

US FDA Clarifies Human Subject Requirements for Clinical Investigations

EMERGO SUMMARY OF KEY POINTS:

  • New US FDA guidance clarifies compliance requirements for clinical trial sponsors, investigators and IRBs whose studies fall under both agency and Department of Health and Human Services (HHS) requirements.
  • The guidance focuses on differences in human subject protection requirements between HHS and FDA clinical investigation regulations.
  • FDA is currently updating its clinical regulations to better align with HHS requirements regarding human subject safety and informed consent issues.

New guidance from the...

Source | Stewart Eisenhart
Oct 16, 2018
Canada | Medical Devices

Health Canada Developing MDL Policies for 3D-Printed Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada to publish new guidance on MDL requirements for 3D-printed medical devices.
  • The Draft guidance will cover Class III and Class IV 3D-printed devices.
  • Publication expected in fall 2018.

Canadian medical device market regulator Health Canada plans to publish new draft guidance on Medical Device Licensing (MDL) for 3D-printed devices in the near future.

In a new...

Source | Stewart Eisenhart
Oct 11, 2018
Europe | Medical Devices

KPMG and RAPS: Medical Device Companies Under-prepared for European MDR

EMERGO SUMMARY OF KEY POINTS:

  • A new medical device industry survey finds many firms still lack a firm understanding of the European Medical Devices Regulation (MDR) and related compliance issues.
  • Device manufacturers cite lack of understanding of the MDR as well as shrinking Notified Body capacity as top challenges ahead of the Regulation’s 2020 enforcement deadline.
  • Survey conductors provide several recommendations for manufacturers to more fully prepare for MDR compliance.

A new medical device industry survey shows that many medical...

Source | Stewart Eisenhart
Oct 10, 2018
China | Medical Devices

Chinese Regulators Continue Adding Medical Devices, IVDs to Clinical Trial Exemption List

EMERGO SUMMARY OF KEY POINTS:

  • China’s National Medical Products Administration (NMPA) has expanded its list of medical devices and IVDs exempt from clinical trial requirements for the second time in 2018.
  • NMPA now exempts more than 1,200 products from clinical trial requirements in China.

China’s National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration, has added more medical device and IVD product types to its list of products exempt from clinical trial requirements in the country.

...

Source | Stewart Eisenhart
Oct 8, 2018
Worldwide | Medical Devices

ISO 14155 Update in 2019: Key Changes for Medical Device Clinical Investigations

EMERGO by UL SUMMARY OF KEY POINTS:

  • The third edition of the ISO 14155 standard for medical device clinical investigations is expected in 2019.
  • Broader risk management requirements are a key feature of the revised ISO 14155.
  • Final publication of ISO 14155’s third edition will likely occur in mid-2019.

Revisions to the ISO 14155 standard covering pre- and post-market clinical investigations for medical devices are set to take effect in 2019. Manufacturers and clinical trial sponsors should consider ramifications of the updated standard...

Source | Dietmar Falke Aleksandra Klimaszewski and Stewart Eisenhart
Oct 8, 2018
United States | Medical Devices

US FDA’s Medical Device Division Lays Out Regulatory Guidance Plans for 2019

EMERGO SUMMARY OF KEY POINTS:

  • US FDA’s medical device oversight division identifies key guidance publication plans for 2019.
  • Top FDA Center for Devices and Radiological Health (CDRH) guidance topics for 2019 include cybersecurity, Least Burdensome Provisions and Unique Device Identification (UDI) implementation and compliance issues.
  • Lower-priority CDRH guidance documents may also see publication in 2019 if resources permit.

Updated cybersecurity requirements for medical device premarket submissions, Abbreviated and Special 510(k)...

Source | Stewart Eisenhart
Oct 3, 2018