Our June 2023 MedTech news roundup includes Swissmedic’s Annual Report findings, updates from the MHRA on regulatory reform in the UK, guidance from the FDA on device software functions and its Q-Submission Program respectively, and news from Australia’s TGA on manufacturer evidence for IVDs. For this and more, read on…
FDA publishes updated guidance on premarket submissions for device software functions
The FDA has updated its guidance on the content of premarket submissions for device software functions.
The document provides the FDA’s latest thinking on regulatory considerations regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions (which are software functions that meet the definition of a device under section 201(h) of the FD&C Act).
This new guidance document considers current standards and best practices for device software functions and replaces FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” issued on 11 May 2005.
FDA releases its Q-Submission Program final guidance
The FDA has released final guidance on its Q-Submission Program which aims to provide an overview of the mechanisms available to submitters through which feedback can be requested in writing or during a meeting with the FDA regarding a potential or planned medical device application. Types of applications covered in the guidance include:
- Investigational Device Exemption (IDE) applications
- Premarket Approval (PMA) applications
- Humanitarian Device Exemption (HDE) applications
- Evaluation of Automatic Class III Designations (De Novo requests)
- Premarket Notification (510(k) submissions)
- Clinical Laboratory Improvement Amendments (CLIA)
- Waiver by Applications (CW)
- Dual 510(k) and CLIA Waiver by Application Submissions (Duals)
- Accessory Classification Requests
- Investigational New Drug Applications (INDs) & Biologics License Applications (BLAs) for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act
You can access the final guidance here.
FDA’s CDRH seeks public comment on increasing patient access to home use MedTech
The CDRH’s commitment to assuring all patients have access to safe, effective, and high-quality medical devices involves facilitating access to medical devices when used outside of traditional clinical settings, for example, in the home.
Access to devices outside a clinical care setting may help bridge the accessibility gap by bringing health care directly to patients wherever they are – be it at home, at work, in cities, or in more rural communities.
As part of its effort to expand access to home use technologies (in line with the CDRH 2022-2025 Strategic Priority focused on advancing health equity), the CDRH has called for public comment on a range of questions regarding non-clinical care settings, remote healthcare, and diverse patient populations. You can read more on this, and submit comments here.
FDA Voluntary eSTAR program latest | eSTAR for pre-submissions to CDRH now available
As of 9 June, the electronic Submission Template and Resource (eSTAR) for Pre-Submissions became available for submissions to CDRH.
Starting from 1 October this year, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR, as noted in the “Electronic Submission Template for Medical Device 510(k) Submissions” final guidance.
The eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission and is the only available electronic submission template to facilitate the preparation of 510(k) electronic submissions. Find out more about the eSTAR program here.
FDA shares hurricane emergency preparedness advice for medical device manufacturers
The FDA has shared recommendations for health care providers, device manufacturers, and distributors regarding hurricane emergency preparedness.
During natural disasters and other emergency situations, medical devices may be exposed to fluctuating power, contaminants, or unusual levels of heat or humidity, and disruption to the delivery of devices or critical components may impact the device supply chain.
The best practices outlined by the FDA encourage proactivity from medical device stakeholders to minimise potential disruptions to patient care.
Read the recommendations here.
Swissmedic publishes its Annual Report for 2022
On 9 June, the Federal Council approved Swissmedic’s Annual Report for 2022 – the 20th in its existence. As well as containing performance and financial overviews, the report also provides data on Swissmedic’s wide-ranging activities – spanning employee numbers, volume of authorisation applications, enquiries from the public, media enquiries, warning notifications for medical professionals, and complaints due to infringements of advertising legislation relating to authorised medicinal products.
You can access the Annual Report here.
UK’s MHRA updates guidance on implementation of future regulations
The MHRA intends to introduce regulations that will implement a substantial reform of the current regulatory framework for medical devices in the UK.
The approach to this reform was outlined in the government response to the 2021 consultation on the future regulation of medical devices in the UK. The UK government ensures that there will be a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients.
The guidance here has been updated to reflect the government’s aim to apply core aspects of the future regime for medical devices from 1 July 2025.
New UK regulatory pathway set to support safe patient access to innovative MedTech
Plans are advancing for a new regulatory pathway in the UK that facilitates the development of innovative technologies.
Set for launch later this year, the Innovative Devices Access Pathway (IDAP) will be run by the MHRA, the National Institute for Health and Care Excellence (NICE), Health Technology Wales (HTW) and the Scottish Health Technology Group (SHTG).
By providing innovators and manufacturers with a multi-partner support service including targeted scientific advice, the aim of this new programme is to help remove any uncertainty from the route to access, bringing innovative new products that can transform health outcomes to patients sooner.
Australia’s TGA publishes new guidance on manufacturer evidence for IVD medical devices
The TGA no longer accepts ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, with an exception for manufacturers who made a Declaration of Conformity under the EU IVD Directive before 26 May 2022.
IVD medical devices that are already approved for supply based on ISO 13485 certificates will need to transition to another form of acceptable manufacturer evidence once the certificate expires, to continue to supply in Australia.
This guidance from the TGA helps sponsors to identify the actions they must take in order to transition to new manufacturer evidence and ensure ongoing regulatory compliance.
That concludes our June 2023 MedTech news roundup. Check back in July for more medical device news and updates.
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