Brandwood Biomedical Newsletter April 2010
Monday, April 19, 2010 at 10:43AM New Australian IVD Regulations start July 1. Are you ready?
After protracted consultations, negotiations and rescheduling, the new Australian IVD regulatory framework is finally set to commence on July 1st 2010. Most IVDs are currently exempt from pre-market approval requirements, but the new system intends to provide regulation for all IVDs. New IVD products introduced after the commencement date will need to be included on the ARTG by means of a formal application to TGA.
For devices already on the market before 1st July, a four-year transition period will apply for manufacturers to obtain inclusion on the ARTG. IVDs introduced on or after 1 July will need ARTG inclusion before they can be supplied. Do you have an IVD close to market? Acting before July 1 may buy you four years to upgrade your systems and compliance. Time is running out for this critical regulatory decision. Contact us for more advice on establishing market precedent.
For detailed reviews of the new regulations see the following recently published articles by Brandwood Biomedical Senior Consultant Paul Cohen:
- The changing regulatory environment of in vitro diagnostics: implications for sponsors, manufacturers and laboratory users (published in Australian Journal of Medical Science)
- Personalised Medicine – Navigating Dx/Rx Co- development (published in Australasian Biotechnology, AusBioTech).
Poor compliance of Class 1 medical devices - TGA crackdown coming?
Recent figures reported by TGA showed that random application audits found 40% of Class I ARTG entries were invalid, leading to cancellation of the ARTG approvals. Although the availability of direct electronic entry to ARTG for Class I devices is not currently under threat, TGA are currently looking for ways to improve compliance. Expect more refined targeting mechanisms, and mandatory audits for serial offenders.
Are you preparing a Class I device submission? Contact us for advice on ensuring your compliance and so you can submit your entry to ARTG with confidence.
New Team Members Strengthen Reimbursement and Asian Regulatory Expertise
We are very pleased to welcome our newest team members, Laurence Fong and David Harrison.
- Laurence recently headed up the market access division of leading international consultancy IMS Health and has special expertise in medical device reimbursement.
- David has lengthy experience in regulatory and quality in Asia, with tours of duty in both Tokyo and Beijing for leading international diagnostics and device manufacturers
Watch out for special issues on reimbursement and on Asian regulatory affairs in forthcoming newsletters.
New approach for ISO 14155 – International standard for the Clinical Investigation of Medical Devices
A revised version of the clinical evaluation standard ISO 14155, the international standard for the clinical investigation of medical devices was released earlier this year, and sees a number of updates and changes to the standard. The new standard combines the previous two standards of ISO14155 (Part 1 and 2) into one and has been reformed to level the playing field for clinical investigations conducted around the world – both economically and ethically.
ISO 14155 is not as well recognised as other ISO standards, with Japan and the U.S FDA failing to accept the old standard. It has been argued that the standard lacks essential details and content, which are challenging to include in a document that needs to be flexible enough to pertain to clinical evaluations conducted all over the world under different conditions. However, the rewrite has been harmonised with ICH GCPs where possible while still remaining device-specific. The new approach deals with clinical research from a project management perspective, with the inclusion of sufficient narrative to teach a sponsor how to conduct a clinical investigation.
DevDx Clinical to sponsor AusMedtech seminar featuring update to ISO 14155
Want to learn more? DevDx Clinical will host a special seminar on Clinical Trials at the forthcoming AusMedtech conference. Dr. Danielle Giroud, member of the ISO drafting committee for ISO 14155 will present the changes to ISO 14155. Click here for a current programme. To register for the conference click here.
WMDO – education and development for medical device professionals
WMDO is devoted to providing medical device professionals with a platform for developing their skills and knowledge of various aspects of the industry, from clinical trials and regulatory affairs to project management and sales and marketing. The world’s only forum dedicated solely to the educational development of the global medical device industry is gathering momentum as the group works to create a novel virtual learning centre. The organisation is working towards establishing a comprehensive collection of online training courses and resources with input from experts from around the world, with the ultimate aim of providing professionals with globally recognised certification and qualifications.
Brandwood Biomedical senior consultant Paul Cohen has accepted an invitation to join the senior faculty board of WMDO, as expert advisor in medical device regulation and clinical affairs in the Asia Pacific. WMDO will debut in Australia at the AusMedtech conference on 1st -2nd June in Sydney. Click here to learn more about how WMDO can support you and your organisation.
Arthur Brandwood to present at upcoming AusBiotech seminar - Integrating the Regulatory and Product Development Processes
Managing Director Arthur Brandwood will present at an upcoming AusBiotech seminar on 6th May in Sydney featuring partnership with product development companies. Arthur’s presentation will focus on integrating regulatory and product development processes and the essential role it plays in accelerating your market access by doing things once and doing them right the first time. Click here for more information and to register for the event.
Congratulations Analytica!
We are pleased to congratulate client Analytica on their recent licensing and distribution partnership with Medical Australia, following their 510(k) clearance in March for their AutoStart Burette and AutoFlush. Analytica’s Autostart Burrette uses a novel design to automatically restart primary infusion once medication is dispensed, through an enhanced float system. Read the Analytica Announcement here.
FDA takes steps toward 510(k) reform
There has been talk of change to the FDA’s 510(k) pre market notification process for some years now. Increasing pressure from lobby groups, plus the changed climate under the current US administration has strengthened the push for reform. In February a public meeting was held by the FDA to discuss the issues surrounding the 510(k) process and its effectiveness. Presentations by FDA representatives highlighted FDA concerns related to the current process.
The 510(k) process involves applicants claiming substantial equivalence of a new low risk device to devices already approved. This can allow applicants to compare and liken their devices to those approved up to thirty years ago, creating cause for concern over the effectiveness and validity of the process. FDA expressed particular concerns that manufacturers have difficulty selecting appropriate predicate devices and prefer to select the "lowest common denominator" device, or a number of devices as predicates to cover all features of the new device. FDA are considering methods of simplifying and improving the predicate selection process, with suggested ideas including the publication of more information about approved devices, and the restriction of technically obsolete predicates.
Some higher risk devices and life sustaining or implantable devices are currently permitted to apply for approval through the 510(k) process. A recent report by the U.S Government Accountability Office (GAO) has raised concern over this and recommended a swift issue of regulations for Class III device types currently allowed to enter the market via the 510(k) process.
In addition, FDA expressed concern about perceived limits to post-market control of 510(k) devices. Post market studies are not a requirement for 510(k) devices in the U.S and FDA has no officially explicit authority to withdraw 510(k) clearances. The non-requirement for 510(k) device manufacturers to notify the FDA of purchase, sale or transfer of 510(k) ownership also presents difficulties for the FDA in tracking post-market activities and adverse events.
The public meeting addressed these issues and more, with the program including a number of presentations by CDRH and speakers from the industry. For a transcript of the meeting – and video files of the proceedings, click here.
US industry association Advamed responded by asserting that although there’s certainly room for improvement, the 510(k) process is essentially sound. Advamed recently released a letter of recommendations in response to the FDA’s request for comments following the public meeting, in which many of the proposals and points raised at the meeting are echoed. The news release and letter can be viewed on the Advamed website here.
Dramatic Slow Down in 510(k) reviews
Amongst all of this discussion of reform, recent experience shows a dramatic blow out in processing times for 510(k) reviews, with applications routinely going over the 90 day review target. A combination of pressures for more thorough review, increase in applications and FDA’s recent relocation to White Oak have all slowed down reviews.
Need help with applications to FDA? In the current climate, strategy is vital. Consider your needs for pre-filing consultations and the possibility of third party assessment alternatives. Brandwood Biomedical has extensive experience of direct interactions with FDA to support 510(k), PMA and IDE reviews. Contact us to learn more.
