Regulatory Newsletter - Edition 17
We're back with the latest issue of Trinzo’s regulatory newsletter ?? Take a few minutes to read through the most up-to-date news in our industry.
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FDA
FDA has released a new draft guidance document on Predetermined Change Control Plans for Medical Devices. A PCCP is described as the documentation which describes the changes that are being made to a device, and the way in which those changes will be assessed. This guidance includes information on the types of changes that the FDA consider appropriate for a PCCP, along with the information that should be included in the PCCP. This is relevant for all submission types, including PMA, 510(k), and De Novo.
Comments should be submitted by 20th November 2024.
Final guidance on use of the Electronic Submission Template for Medical Device De Novo Requests has been released. This guidance provides support and resources to users of electronic submissions, including relevant terminology, the format, structure and use of the current submission template, and information related to template waivers and extensions. The FDA will require that electronic electronic submissions are used as of October 1st, 2025, but eSTARs may be used voluntarily during the transition period up to that point.
Draft guidance on Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle has been released by the FDA. This guidance provides information on how PPI can be collected and submitted by sponsors or manufacturers, the recommended quality of this information, and how it could be used by the FDA in decision making and benefit-risk assessment.
Comments on the guidance should be submitted by 5th November 2024.
Following publication of the final rule on LDTs, the FDA held a webinar on 22nd August for laboratory IVD manufacturers and other stakeholders to whom this topic is relevant. The webinar covered medical device reporting requirements, correction and removal reporting requirements, and quality system complaint requirements. The webinar materials, including the presentation, slides and transcript can be accessed here .
Final guidance has been released on the Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. This guidance is intended to provide clarity on the eligibility of the product codes that are applicable to the program, and the individual reporting conditions, including those where individual reports are required.
Guidance on Acceptable Media for Electronic Product User Manuals has been released by the FDA. This guidance clarifies that user manuals can be provided either electronically (e.g. as a website download, CD, USB etc.) or in paper format.
There has been an update to the FDA's list of US marketed AI/Machine-Learning enabled medical devices. As of the August 7th update, there are 950 devices on this list, which is an increase of 68 devices since their May update.
EU
The European Commission has launched an initiative to seek public opinion on a proposed amendment to Regulation (EU) 2022/1107 on common specifications for class D IVDs. The proposed update includes the addition of 7 annexes covering the following infections:
Feedback is being accepted until 16th September.
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Rest of World
TGA has released a survey to gather opinions on updating the Essential Principles to align with the MDR and IVDR GSPRs. In support of this, a consultation paper was released to provide background information on the consultation and a list of all of the questions that are included in the public survey. Attachment 1 references each change that has been proposed to the Essential Principles, along with a comparison between the Essential Principles and the relevant GSPRs. The survey remains open until 16th October 2024.
TGA has announced upcoming changes to the use of guidance on their website. This change is coming as a result of research which showed that users have found the existing guidance to be unclear and difficult to navigate. The changes, which are to be gradually rolled out from September, will include the introduction of:
Following the introduction of new regulatory requirements on 1st July 2024, for medical devices which contain medicinal, microbial, recombinant, or animal origin substances in Australia, the TGA has released draft guidance on these new requirements and the transition arrangements. This guidance includes information on reclassification, and lodging of ARTG applications.
Feedback on the draft guidance is welcomed by the TGA until 9th October 2024 and can be submitted here .
MHRA has launched a public consultation in relation to an increase in the statutory fees for ongoing recovery of costs. The consultation paper outlines 5 different proposals, which would be implemented from April 2025 under secondary legislation:
An online survey , containing 7 questions, is open until 24th October 2024.
Cybersecurity
The European Commission has shared a publication by the JRC on cybersecurity in the health and medicine sector: a study on available evidence of patient health consequences resulting from cyber incidents in healthcare settings. This study focuses on reported cybersecurity incidents in the healthcare industry and whether these incidents had any impact on patient health. While there were no reported injuries or deaths in relation to the incidents that were examined, the study revealed vulnerabilities in this space and outlines the hurdles that will be faced as the risk of cybersecurity incidents inevitably grows with the increase in digitalisation.
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