FDA commissions review of the 510(k) process
Very interested to read recently that the FDA has commissioned the US Institute of Medicine (IOM) to review the 510(k) process. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183497.htm Whilst the review isn’t due to be complete until March 2011 I’ve already seen several articles from industry associations defending the current process. As part of the IOM there will be two public workshops over the next nine months and we’ll comment on the noises coming out of these workshops when we hear them.
BSI acquires German Notified Body
BSI has acquired German based Notified Body EUROCAT. EUROCAT is accredited for the certification of devices, IVD’s and active implantable’s and also offers product testing. See the official BSI press release here .
BSI adds to Fast Track service offering
BSI has added a new accelerated programme for device manufacturers (CE-Dedicated Fast Track) looking to bring their product to market quickly.
CE-Dedicated FastTrack offers reviews within 45 working days or less and does this by dedicating a reviewer to the project and by performing the review off-site. This is the 4th such initiative BSI have introduced in the last couple of years and in a market where speed to market is key it will prove attractive with device manufacturers although it should be noted that such a service comes at a premium cost.
The Drug Tariff – disallowed products
A listing on the UK Drug Tariff allows manufacturers of certain medical devices to provide their products over the counter in pharmacies and gain direct reimbursement for the product. This link http://bit.ly/TtLbB takes you to the PSNC web-site which provides a listing of all those products which are disallowed products.
Over the years we’ve helped lots of clients get their products listed on the UK Drug Tariff. For details of how we can help please email kevin.webb@medqol.com
FDA promises tighter enforcement action
In a 6 Aug press release FDA Commissioner Margaret Hamburg outlined how the FDA is implementing a five point strategy to improve their effectiveness system – http://bit.ly/3mEH0x
The plan involves setting post inspection deadlines, speeding up warning letters, the prioritization of enforcement issues and quicker action being taken against infringers. The agency will also introduce a formal warning letter close out process to make it clear when remedial action has been taken satisfactorily.
Updated clinical trials guidance document issued by MHRA
The MHRA has recently issued updated guidance on clinical investigations to be carried out in the UK. It’s an update on previously available guidance that takes into account the impact of 2007/47/EC, the revision to the directives which takes effect in March 2010. One of the major updates in this document is the confirmation that it will be much more difficult to obtain regulatory approval using only clinical literature and that more products will require a clinical investigation.
In addition the guidance talks the reader through making an application, outlines how it will be processed and what documentation will be required.Download here mhra-guidance-re-clinical-investigations-july-2009
For guidance as to whether your product will require a clinical investigation please contact Danielle.avadis@mediqol.com
India introduces proposals to regulate medical devices
The Indian Central Drugs Standard Control Organization (ICDSO) has recently published formal proposals outlining how it intends to regulate the medical devices sector. Currently medical devices are either regulated as drugs (if they fall in a list of ten product types) or not regulated.
The plans include the introduction of a risk based classification system with increased regulatory requirements and documentation being required for higher risk devices. The plans also suggest the involvement of Notified Bodies in the certification process and the introduction of a Indian equivalent of the CE mark.
If you’d like a copy of the 83 page document please drop us an email at enquiries@mediqol.com
2007/47/EC will force more companies down the clinical investigation route
Now that’s an obvious statement to anyone who is familiar with the amending directives but I’ve read a couple of articles lately which reinforce the point and suggest that the alternative “literature route” is going to be even more difficult to justify than perhaps originally envisaged.
A recent article published in Clinica and written by NSAI (National Standards Authority of Ireland) outlined what they expect manufacturers to be able to demonstrate if they want to obtain a CE mark for high risk products via the literature route. NSAI have specifically said that:
1. they expect the products technical characteristics to be very similar to the product referenced;
2. that biologically they expect the products of a manufacturers products to be the same as the product referenced; and
3. that the product should be clinically equivalent in that it is to be used on the same type of end user and have the same access point or application.
Given Notified Bodies will be expected to interpret and apply the amending directives in a similar fashion I think we should assume that all Notified Bodies will be taking this approach.
So what are the implications for manufacturers of Class III devices? Well time to market is obviously going to be longer and more expensive if manufacturers are forced down the investigation route. I think we’ll also see an improvement in the quality and depth of clinical evaluations produced by manufacturers seeking approval by this route. Well they’ll have to if they are going to have a chance of being accepted!
For advice and guidance on how this might affect any of your products please email jane.arnold-round@mediqol.com or Kevin.webb@mediqol.com
Borderline Medical Devices – Guidance Document
MEDDEV 2. 1/3 concerning borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative has been updated to take account of the changes introduced by the 2007/47/EC amendments and is available to download here.
This guidance document is essential reading for manufacturers of medical devices intending to CE mark combination products that incorporate a medicinal substance or a human blood derivative.
Mandatory compliance with 2007/47/EC – Only 8 months to go!
I recently gave a presentation on the impact of 2007/47/EC to about 30 medical device manufacturers. I think it went ok, no one seemed to be asleep at the end!
There are now only eight months to go until compliance with the new MDD is mandatory and we are starting to see more and more companies asking for help with clinical evaluations; the requirement for which are significantly increased by the directive. There are 15-20 other significant amendments which you can find summarised in the presentation here.
