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Global Medical Device News

Japan | Medical Devices

Japanese regulators increase medical device registration fees for 2019

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Japan’s PMDA has increased medical device registration fees as of Aprill 1, 2019.
  • Any Japanese market registration received after March 29, 2019 will be subject to the new fees.

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants.

The new fees have taken effect as of April 1, 2019 (link in Japanese). PMDA has issued three...

Source | Stewart Eisenhart
Apr 1, 2019
United States |

Latest insights on FDA expectations from the HFES Health Care Symposium

EMERGO BY UL SUMMARY OF KEY POINTS:

  • FDA reviewers emphasized the need for “usable” human factors documentation in premarket submissions at recent Human Factors and Ergonomics Society symposium;
  • Thorough utilization of use-related risk analysis becoming more important, according to FDA.
  • FDA officials recommend that manufacturers reduce use-related risks in their devices and stay current with post-market surveillance requirements.

Manufacturers, consultants, researchers, and regulators all descended upon Chicago this week for the annual...

Source | Erin Davis and Allison Strochlic
Apr 1, 2019
Worldwide |

GDPR and human factors studies for medical devices: Key issues for manufacturers and sponsors

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The European GDPR has ramifications for how medical device human factors researchers collect and manage data related to study participants, even outside of the EU.
  • Human factors researchers should work with their clients (if they serve in a consulting capacity) and other third parties (e.g., vendors) to define roles and responsibilities early during study planning and develop best practices that comply with GDPR requirements.
  • All participant data management decisions and rationales should be properly documented to
  • ...
Source | Stewart Eisenhart
Apr 1, 2019
United States | Medical Devices

US FDA targets safety of materials used in medical devices

EMERGO BY UL SUMMARY OF KEY POINTS:

  • FDA plans closer evaluations of certain materials used to manufacture medical devices marketed in the US.
  • The agency is targeting potential risks of inflammatory reactions in some patients to devices such as breast implants, metal-on-metal joint replacement devices and birth control devices using metal materials.
  • New premarket review requirements as well as post-market surveillance obligations may come from FDA’s plans.

US medical device regulators are planning more focused evaluations of materials...

Source | Stewart Eisenhart
Mar 26, 2019
Brexit impact on medical device companies
Europe | In-Vitro Diagnostic Devices, Medical Devices

Brexit delay: Reduced risk of no-deal withdrawal for medical device manufacturers?

EMERGO BY UL SUMMARY OF KEY POINTS:

  • No Brexit on March 29th;
  • Vote set for next week on agreement in UK parliament;
  • Delay until May 22rd with conditions;
  • New Brexit day on April 12th if no agreement is accepted.

European Union Member States have granted UK negotiators a brief extension on their Brexit withdrawal date (Brexit Day). The British government has a small window in which to avoid a no-deal withdrawal scenario, but whether an “orderly” Brexit can actually be accepted remains a very open...

Source | Ronald Boumans
Mar 22, 2019
United States | Combination Products

Applying human factors to nicotine replacement therapy drug products

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US regulators reevaluating how to oversee nicotine replacement therapy (NRT) products;
  • NRT manufacturers should utilize human factors in developing NRT product labels;
  • Self-selection studies recommended for developing NRT product labeling.

Nicotine replacement therapy (NRT) drug products, such as patches, gum and lozenges, have been around for more than 30 years. More novel products such as e-cigarettes provide additional choices for people using NRT for smoking cessation. But, like any other drug...

Source | Stephanie Larsen and Richard Featherstone
Mar 21, 2019
Europe | In-Vitro Diagnostic Devices, Medical Devices

Dutch regulators weigh in on no-deal Brexit impact for medical device companies

Currently Brexit is planned on 29 March 2019, but it is not clear how this process will be executed. One of the realistic outcomes is the ‘no-deal’ Brexit, where the UK leaves without any agreement on how trade and people movements with the EU will be regulated. This means the UK will become a third country from the EU perspective and it is likely not all manufacturers have taken all necessary measures to keep placing devices on the market. All Member States are preparing for this situation. The Dutch authorities have asked Emergo by UL to help in communicating their position,...

Source | Ronald Boumans
Mar 21, 2019
United States | Medical Devices

FDA issues final guidance on devices containing animal-derived materials

EMERGO BY UL SUMMARY OF KEY POINTS:

  • FDA has issued final guidance on medical devices containing animal or animal-derived materials.
  • The guidance supersedes the version issued in 1998 and expands on recommendations in this earlier document.
  • Recommendations in the guidance align with ISO standards series that addresses medical devices containing animal tissue and animal-derived materials.

The US Food and Drug Administration (FDA) issued...

Source | Kate Jablonski
Mar 18, 2019
United States | Medical Devices

Fatal Medical Error: Too common to investigate thoroughly?

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Investigations of preventable medical errors in the US healthcare system in need of revamp;
  • Scale of fatal medical errors hindering more rigorous investigations;
  • Multidisciplinary approach incorporating human factors components needed to address ongoing medical use errors.

On Friday, March 1, 2019, a Tesla automobile was involved in a fatal crash in Palm Beach, Florida. Considering the possibility that the vehicle crash occurred while the vehicle was in autopilot mode, the National Highway Traffic...

Source | Michael Wiklund
Mar 14, 2019
Australia | Medical Devices

Australian medical device regulators preparing Brexit contingency plans

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The Australian TGA has drawn up plans to blunt the impact of Brexit on the country’s medical device market.
  • TGA will continue recognizing conformity assessments from UK-based Notified Bodies for existing and new ARTG listings and applications.
  • Short-term effects of a potential orderly or no-deal Brexit should be minimized by TGA measures as described.

The Australian Therapeutic Goods Administration (TGA) has developed measures to minimize potential negative market impacts of the UK’s Brexit...

Source | Stewart Eisenhart
Mar 13, 2019