Our October MedTech news roundup includes the latest from the EU Commission on clinical evaluation assessment reports and specifications for products without an intended medical purpose, as well as news from the UK’s MHRA regarding a new UK Approved Body. A plethora of updates and guidance from the FDA is also included, plus news from Health Canada and Australia’s TGA. Read on for more…
EU Commission shares expert decision & opinion on clinical evaluation assessment reports
The EU Commission has published a scientific opinion that reflects the views of independent experts on clinical evaluation assessment reports (CEARs) produced by notified bodies.
The advice is provided in the context of the clinical evaluation consultation procedure (CECP), which is an additional element of conformity assessment by notified bodies for specific high-risk devices – as outlined in MDR Article 54 and Annex IX, Section 5.1. Read the expert decision and opinion here.
UK’s MHRA appoints new UK Approved Body to certify medical devices
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies.
DEKRA is the first new UK Approved Body appointed to certify medical devices since Brexit, after becoming the first company to complete the new designation process that any potential organisation must now go through to become approved to certify medical devices in the UK. They are now designated as a UK Approved Body to undertake assessments for general medical devices (known as Part II designation). Find out more here.
Common specifications laid down for products without an intended medical purpose
The EU Commission has laid down common specifications for the groups of products without an intended medical purpose listed in Annex XVI of the EU MDR. Product groups include contact lenses, surgically invasive anatomy-modifying products, equipment used to reduce, remove, or destroy adipose tissue, high intensity electromagnetic radiation-emitting equipment, and equipment intended for brain stimulation. Find out more about the regulation here.
FDA: Medical device eSTAR and eCopy Premarket Submissions can now be sent online
At the beginning of this month, the FDA announced that manufacturers may now send electronic copy (eCopy) or electronic Submission Template and Resource (eSTAR) premarket submissions for medical devices online through the CDRH Customer Collaboration Portal.
Building on the progress tracker for 510(k) submissions launched in 2021 and the trial process of electronic uploads launched in July 2022, the CDRH Portal now allows anyone to register for a CDRH Portal account to send CDRH eCopy or eSTAR premarket submissions online.
Find out more on this here, and to read more about the FDA’s voluntary eSTAR program, see here.
FDA publishes final guidance on postmarket surveillance under section 522 of FD&C act
Published on 7 October, the final guidance aims to assist manufacturers of devices subject to section 522 postmarket surveillance orders by providing information on how to fulfil section 522 obligations.
Postmarket surveillance is “the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device”. Section 522 of the FD&C Act provides the FDA with the authority to require manufacturers to conduct postmarket surveillance of certain class II or III devices at the time of approval / clearance / any time thereafter. You can access the final guidance here.
FDA’s CDRH launches Total Product Life Cycle Advisory Program pilot
On 11 October, the FDA’s CDRH announced the launch of their Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot.
TAP is a voluntary program intended to de-risk the medical device “valley-of-death” by providing the industry with earlier and more frequent interactions with CDRH, more strategic input from stakeholders, and proactive, strategic advice from CDRH to spur more rapid development of high-quality, safe, effective, and innovative medical devices. Find out more here.
FDA releases final guidance on procedures for handling post-approval studies imposed by PMA order
Published on 7 October, the purpose of the guidance is to assist stakeholders with understanding post approval study (PAS) requirements imposed as a condition of PMA approval.
A Post-Approval Study (PAS) is usually a clinical or non-clinical study, as specified in the PMA approval order, and is typically intended to gather specific data to address questions about the postmarket performance of, or experience with, an approved medical device.
Access the final guidance here, and for more information on the PMA application process – take a look at our fact sheet here.
FDA publishes MDUFA for FY2023
This month the FDA has published their Medical Device User Fee Amendments (MDUFA) for Fiscal Year 2023. The Annual Establishment Registration Fee sits at $6,493, with all establishments obligated to pay accordingly. There are no waivers or reductions for small establishments, businesses, or groups. Other fees for Fiscal Year 2023 can be found here.
FDA releases final guidance documents on user fees & performance goals for premarket submissions
The Medical Device User Fee Amendments of 2022 (MDUFA V) amended the FD&C Act to authorise FDA to collect user fees for the review of certain premarket submissions received on or after 1 October, 2022 – including 510(k) premarket notification submissions and PMAs (premarket approval applications).
The additional funds obtained from user fees enable the FDA, with the cooperation of the industry, to improve the medical device review process to meet certain performance goals and implement improvements for the medical device review process.
Performance goals were negotiated and agreed under MDUFA V for 510(k)s and PMAs received in FY 2023-2027. These performance goals and process improvements are described in the following recently published final guidance documents:
- FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals
- FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
Furthermore, on 5 October, the FDA released final guidance to identify the types of 510(k)s subject to user fees, exceptions to user fees, and the actions that may result in refunds of user fees that have been paid.
FDA shares policy for device software functions and mobile medical applications
The FDA has issued final guidance to communicate how they intend to apply their regulatory oversight to certain device software functions that meet the definition of a medical device – including device software functions and mobile medical applications (MMAs) intended for use on mobile platforms or on general-purpose computing platforms.
The guidance also provides information on some software functions that do not meet the device definition and are not subject to applicable FDA regulatory requirements. You can read the final guidance here.
FDA issues final guidance on MDDS, medical image storage devices, and medical image communication devices
The FDA has issued final guidance regarding medical device data systems (MDDS), medical image storage devices, and medical image communication devices.
FDA does not however, intend to enforce the requirements of the FD&C Act for hardware functions that are considered to be MDDS, medical image storage devices, nor medical image communication devices, provided that the hardware function is limited to assisting certain software functions.
Health Canada to require certain data on Class II lab-based monkeypox tests
The Medical Devices Directorate (MDD) currently classifies in vitro diagnostic tests for monkeypox as follows:
- Laboratory monkeypox tests | Class II medical devices based on Schedule 1, Part II, Rule 2 of the Medical Devices Regulations
- Near-patient monkeypox tests (including point of care or self-tests) | Class III medical devices based on Schedule 1, Part II, Rule 6 of the Medical Devices Regulations
Under the current regulations, Class II devices do not generally require scientific review before they enter the Canadian market. But this month, Health Canada announced that they intend to ask manufacturers to submit analytical sensitivity data, precision testing, and clinical data using all claimed sample types for Class II lab-based monkeypox tests before approval.
Australia’s TGA to accept medical device assessments from Singapore’s HSA
Australia’s TGA has amended their guidance on the use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices and IVDs. As of this month, assessments from Singapore’s HSA will be accepted.
The full guidance provides an overview of how specific overseas assessments and approvals can be used by applicants to support an abridged version of a TGA conformity assessment certificate application. Take a look at the guidance here.
That concludes our October MedTech news. Check back in November for our final roundup of 2022!
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