{{ phone }} {{ location }}

Emergo by UL logo

         

Global Medical Device News

United States | Medical Devices

US FDA Adds Details for Medical Device Conformity Assessment Accreditation Program Pilot

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has provided more information on its upcoming Accreditation Scheme for Conformity Assessment (ASCA) pilot program.
  • ASCA will include at least five FDA-recognized voluntary consensus standards for medical devices.
  • The pilot is expected to launch by September 2020.

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published additional information on its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for...

Source | Stewart Eisenhart
Oct 31, 2018
Saudi Arabia | Medical Devices

Saudi Regulators Adjust Timeframes for Medical Device Market Application (MDMA) Submissions

EMERGO SUMMARY OF KEY POINTS:

  • The Saudi Food and Drug Authority (SFDA) has announced updates to certain timeframes for Medical Device Market Application (MDMA) submissions.
  • Revised MDMA deadlines pertain to registration payments and responses to SFDA requests for additional information.

Medical device regulators at the Saudi Food and Drug Authority (SFDA) have updated deadlines for pending Medical Device Market Application (MDMA) submissions.

According to Emergo by UL sources in Riyadh, new MDMA timeframes for manufacturers and their in-...

Source | Stewart Eisenhart
Oct 30, 2018
Brazil | In-Vitro Diagnostic Devices, Medical Devices

Brazil’s ANVISA Reports Increase in Medical Device Modification Submissions

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA reports progress in meeting review timeframes for medical device and IVD reviews between July and September 2018.
  • ANVISA also reports a spike in modification applications following changes to Brazilian importing and inspection requirements for medical devices and IVDs.
  • Rejection rates for cadastro, registro and IVD submissions over the past three months remain in line with yearlong trends reported by ANVISA.

Brazilian medical device market regulator ANVISA has reported a major increase in...

Source | Stewart Eisenhart
Oct 29, 2018
South Korea | Medical Devices

South Korean MFDS Plans Greater Alignment of Quality Requirements with ISO 13485:2016

EMERGO SUMMARY OF KEY POINTS:

  • South Korea’s MFDS to harmonize Korea Good Manufacturing Practice (KGMP) quality system regulations to ISO 13485:2016.
  • Aligning KGMP to ISO 13485 would pave the way for South Korean participation in the Medical Device Single Audit Program (MDSAP).
  • MFDS is accepting industry feedback on the plan through November 2018.

The South Korean Ministry of Food and Drug Safety (MFDS) has issued draft plans to align Korea Good Manufacturing Practice (KGMP) more closely to the ISO 13485:2016 medical device quality system standard...

Source | Stewart Eisenhart
Oct 24, 2018
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