Show Articles for 'REGULATORY AFFAIRS'

 
BY PAUL COHEN // 0 COMMENT(S)

TGA (Therapeutic Goods Administration) restructures its internal organization combined with an increased use of information technology to ensure a more efficient regulatory review and continuous post market supervision process. Two separate regulatory groups have been created, one that will focus on authorizations for product market access and another group monitoring products already on the market.



BY DANIELLE GIROUD // 0 COMMENT(S)

It has been a while since the TC 194WG 4 produced the final version for the FDIS which was sent to the ISO committee end of March 2010. The FDIS is now finally out for formal voting since September 9th, 2010 with a deadline for voting on November 9th 2010.


Many clinical professionals wonder when the requirements of this new FDIS can be used. For clarification, after an FDIS, only editorial corrections can be made. As a consequence, the requirements of the ISO 14155 FDIS (2010) will not change with exception for some editorial corrections and clinical professionals can thus start using the new version.



BY DANIELLE GIROUD // 0 COMMENT(S)

How often have you heard someone say: “That will never happen!”, in response to a question about a potential risk of a medical device?  This is an assumption you should not be willing to make. The reality is, with most medical devices, if something does go wrong it may cause serious damage. The intention of this article is not to paint an overly dramatic picture nor to  create rampant paranoia, but to provide a realistic view of risk management.



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As a former scientific reviewer within ODE, I was not at all surprised to see the internal survey results of how “intended use” and “indication for use” were inconsistently interpreted and applied.  This issue has been around and debated internally since the mid to late 80’s and has never truly been addressed directly by the Agency.  This inconsistency of interpretation can either cause a major surprise during a 510(k) review or can render a marketed device misbranded and adulterated for being promoted for an unapproved use.  This inconsistency deserves the Agency’s highest attention since it can create a major problem for the manufacturer.  At one end of the spectrum a finding of not substantially equivalent during a 510(k) review can end a product or a company.  At the postmarketing phase of the product lifecycle, a misbranding/adulteration violation of the FD&C act can cause a suspension of sales of the medical device and litigation as a result of a serious injury/death due to use of the medical device for unapproved uses.



BY DANIELLE GIROUD // 0 COMMENT(S)

The EU guidance document for Serious Adverse Event reporting is undergoing further changes. Whilst the terminology has now been synchronized completely with the FDIS ISO 14155:2010, industry and regulators are still debating over...



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• Introduction of Third Party Conformity Assessment
• Reclassification of Orthopaedic Joints
• All Class III and AIMD implants to require TGA assessment
• All Class IIb implants subject to application audits

TGA have today announced some long anticipated and far reaching reforms to the Australian Conformity Assessment of Medical Devices.  These reforms have resulted from a series of reviews into the level of regulatory assessment in Australia and particular disquiet with the unequal treatment of Australian manufacturers - who are currently required to be directly regulated by TGA for devices of all classes, whereas overseas manufacturers may gain TGA approvals by means of recognition of CE certifications.

The reforms are intended to achieve three principle aims:



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We would like to thank everyone who participated in making the ISO 14155 webinar series a great success and we hope that you all found the information helpful. Your response was overwhelming and we can assure you that we will continue to provide our users with superior webinar offerings in the very near future. Here are the resulting questions and answers from this month’s webinar:



BY PATRICK KULLMANN // 0 COMMENT(S)

“First Things First - Medical Device Success” is the second article in the “Napkin to Market” series authored by Patrick Kullmann of CG3 Consulting.

Successful Medical Device Market Introduction - First Things First
In last month’s article I outlined the risks and the rewards of the early start device company in the fundraising process with “Rules of the Raise” - how to successfully raise financial resources in a difficult economic environment for your startup medical device company. This month we are focusing on the steps for taking a medical device concept to the market...



BY DANIELLE GIROUD // 0 COMMENT(S)

The ISO 14155 version 2011 was published on February 1st, 2011. Long awaited by both industry and competent authorities, the big question immediately after publication was ‘when to expect European Harmonization?’. The European Harmonization is the milestone to reach for Europe’s official acceptance of the standard and thus a mandatory step now anxiously expected by all players.