The guidance document defines Field Corrective Actions (FCAs) which include Field Safety Corrective Actions and Non Safety related Field Corrective Actions. The actions are classified based on the type and extent of the corrective action and importantly, the level of risk posed to patients, users or others affected by the device’s use. The classification system provides a mechanism for manufacturers to develop comprehensive strategies including planning for communication, action and follow up and for regulatory authorities to monitor progress of the FCA.

The guidance document provides practical examples of each type of FSCA (of which there are 5) and Non Safety related Field Corrective Actions (of which there are 3). These are given below.

Safety Related Field Corrective Actions (e.g. FSCA):

1. Device Removal (Device Recall)
2. Device Modification
3. Implant Alert
4. Device Precaution
5. User Warning

Non Safety related Field Corrective Actions:

1. Device Withdrawal
2. Device Enhancement
3. Stock Recovery

The classification system requires manufacturers to propose an expected level of risk to patients, users and others if use of the device was to continue. Classification of FCAs is divided into 3 levels, these are given below:

1. FCA Class I: Taken by a manufacturer when death or serious deterioration in the state of health of a patient, user or other person has occurred, or there is a reasonable probability that exposure to or use of the device can lead to death or a serious deterioration of health.
2. FCA Class 2: Taken by a manufacturer when there is a reasonable probability that the exposure of use of the medical device has or can lead to temporary illness, injury, mistreatment or deterioration of the state of health of a patient, user or another person
3. FCA Class 3: Taken by a manufacturer when there is a reasonable probability that the exposure or use of the device will not lead to temporary illness, injury, mistreatment or deterioration in the state of health of a patient, user or other person.

Whilst still in draft form, the document does provide useful guidance and is a must read for all medical device manufacturers. Find it here.

KD&A can assist your organisation to develop suitable post market procedures to ensure you are prepared and can comply with the regulatory requirements in the markets into which you sell your devices. Visit the Post Market Surveillance System page or contact KD&A.

The decision shows that the Federal Court can and will impose significant penalties on therapeutic goods manufacturers and suppliers who import or supply therapeutic goods without completing the required regulatory actions.

The TGA report that in the period from 2006 to 2009 Export Corporation imported and supplied over 35 products that were not certified by the TGA as required.  These included nutritional and weight loss products as well as body building, muscle growth and vitamin products.

In deciding the applicable penalty, the Federal Court took into account the following:

• The large number of contraventions (numbering in the thousands)
• The lack of appreciation by the company of the seriousness of the regulatory requirements
• The deficiencies in the company’s compliance culture
• The need for the level of penalty to act as a deterrent to others who might be tempted to “make the same mistake” and to serve as a particular message to those involved in importing and distributing sports supplements in Australia

The best advice we can give is if you are unsure of regulatory requirements applicable to your organisation, don’t risk it. Contact KD&A for guidance and assistance.

The details of the mutual agreement are to be defined during 2012 and it is hoped that the agreement will be operative from 2013. The four regulatory bodies will work independently to begin with to certify manufacturers as compliant with mutually recognised good manufacturing practice (GMP) standards. This model will then adapt to allow for joint inspections to the GMP standards. Down the track it is planned that other activities (including product recall) will be completed on a mutual basis.

The mutual agreement will mean reduced regulatory burden for medical device manufacturers in these regions, and may eventually broaden to bring benefit to overseas manufacturers also.  As with many other regions worldwide, a mutually governed approach to medical devices is developing.

For assistance obtaining regulatory certification outside of Australia, please contact KD&A.

The government’s blueprint includes the following:

• Plans to focus on improving communication and engagement with the community with the intention of becoming a well known and understood regulatory agency.
• Plans to establish an Australian Therapeutic Goods Advisory Council which will facilitate direct public feedback and comment on TGA activities
• An intention to improve current arrangements for the regulation of therapeutic goods advertising by creating a central point for all complaints about advertising, and the development of options for further consideration.
• A plan to update and include in the regulation of complementary medicines the ‘guidelines for the levels and kinds of evidence to support indications and claims’ to increase rate of compliance with regulatory and legislative requirements.
• Medical device reforms including increased rigour of pre-market regulatory assessment of high risk devices, reclassification of load bearing joint replacements (from Class IIb to Class III), a requirement that Australian Register for Therapeutic Goods (ARTG) inclusions to specify all devices sold under each ‘kind of medical device’ inclusions, and an increase in the product information available on the TGA website.
• A commitment to maintain an emphasis on self-regulation of industry in relation to promotion of therapeutic goods.
• An indication that a modest increase in fees will apply to implement the fundamental reforms.

Whilst reforms are welcomed, there appears to be some disappointment in the failure to implement reforms to create equality in the promotion of therapeutic goods. Based on the government’s current stance, a level playing field appears somewhat out of reach for industry. It has also been said that an increase in fees is likely to be not well received by sponsors and manufacturers in Australia, with current fees already considered to be significant for smaller companies.

For manufacturers and sponsors, the reality of the reforms is here, meaning it is time to prepare your organisation to comply with the requirements or implement plans to do so. For medical device reforms, transition periods apply however it is recommended that a focus on compliance within your organisation is actioned as soon as possible.

To better understand new requirements for your organisation and for guidance regarding the most effective way to comply,  contact KD&A.

A commonly used standard, 60601-1 is an important tool for manufacturers when demonstrating compliance with the Essential Principles and Essential Requirements.  Standards selection and compliance is an important component of device development, manufacture and testing.

Some changes debated and included in the third edition of 60601-1 are as follows:

The scope of 60601-1 has been expanded to include automatic external defibrillators (AED).

The definition of medical electrical equipment has been expanded to add ‘or compensation or alleviation of disease, injury or disability’ to the definition of medical electrical equipment. Historically, medical electrical equipment was limited to devices intended by their manufacturer to ‘diagnose, treat or monitor a patient.’

Collateral standards in the IEC 60601 family have become a normative part of the general standard on the date of its publication. In effect, this approach allows for an unlimited number of amendments to add new general requirements to IEC 60601-1 because each new collateral standard becomes a nominative part of IEC 60601-1 when published.

However, the most significant change is the requirement for the manufacturers of electromedical equipment and systems to have a formal risk management system in place in order to comply with the third edition of IEC 60601-1.

There is much cross over between ISO 14971, the risk assessment standard for medical devices, and 60601-1 third edition.  For example, 60601-1 features over 100 instances where applications of a specific clause, modification of a test protocol, or provisions of a particular safety feature depend upon a determination that the risk is acceptable (or that there is unacceptable risk). Manufacturers must determine risk acceptability using ISO 14971 complaint risk management process.

For many medical device manufacturers, ensuring compliance with the third edition of 60601-1 is an important issue. Whilst there are many publically available guidance documents online, KD&A recommend working with electrical safety experts in order to properly understand specific product requirements based on the third edition requirements and complete necessary activities to achieve and maintain ongoing compliance.

ACMD review applies to most Class III medical device conformity assessment applications and their advice can have a key impact on obtaining TGA certification for your medical device.  Reports are provided to the ACMD members from TGA assessors (delegates) outlining their review of previously submitted conformity assessment documentation.

As part of the ACMD review process manufacturers are given the opportunity to review the assessor’s reports and provide a limited amount of additional information. This information must be submitted in the form of a pre-ACMD response. The pre-ACMD response will be part of the package submitted to the ACMD for consideration.

The ACMD meet on a quarterly basis and the meeting schedule can be found on the TGA website. Their resolutions and reports are also published on the TGA website.

For further information regarding ACMD processes, conformity assessment for medical devices, or product registration in Australia, contact KD&A.

Medtech experts from around Europe have collaborated to produce a report in which they argue that it is time to introduce randomised clinical trials (RCTs) in the EU for high risk medical devices (these are defined as innovative Class III medical devices and innovative implantable medical devices).The authors also propose centralising the evaluation process of these products.

The authors are aware that the timing of this report’s publication, allows it to be taken into account by those involved in the ongoing rework of the EU Medical Device Directives and that the proposal in the document may dictate the future regulatory outlook for high risk-medical devices.

In the report, the authors note that in the experimental phase after early market introduction, outside the context of trial, there are no laws pacifically targeting the topic of patients rights and states that the device industry should be made aware of the growing importance of generating clinical evidence and the specific expertise this requires.

They authors continued to criticise Europe for allowing earlier market introduction compared with the US, “at a time when the exploratory clinical development phase is not yet completed and the confirmatory phase has not yet been initiated.”

In contrast, in the US, innovative high-risk devices (Class III) typically undergo a thorough pre-market approval (PMA) process and devices are put through a far more demanding clinical trial scrutiny before being allowed on the market. That said, the US system is currently the subject of an internal review by the FDA and the Institute of Medicine (IOM) assessing whether the FDA 510(k) clearance process protects patients as well as it can without limiting improvements in medical devices. This review of the medical devices regulatory systems in the US might widen the gap, the authors suggested.

A critical factor, they note, is the European system is based on the demonstration of safety and performance, whereas the US system requires the pre-market demonstration of safety and efficacy/effectiveness.

“This leads to entirely different clinical trials,” the report says. For the demonstration of device performance, an RCT is neither necessary nor appropriate, whereas it is an essential for the demonstration of clinical safety and efficacy in a controlled way. The level of study evidence required in Europe is much less specified compared with the FDA requirements for a PMA application, they add

They also point out that only one in five of the 8,500 medical devices companies in Europe (probably fewer if companies belonging to a US group are excluded) has approached the US market.

Unfortunately, negative trials are rarely made public. Also, the report continues, final negative decisions on PMA dossiers are not made public on the FDA website. Therefore, it cannot be excluded that devices continue to be marketed in Europe while having failed in the demonstration of efficacy in the RCT required in the context of PNA in the US, as illustrated by a negative FDA panel vote for an endobronchial valve system in 2008.

The authors in this report do not believe the revision, 2007/47/EC, is enough to improve regulations.

“Despite the increase in clinical  trial activity induced by the EU Directive 2007/47/EC, the remaining variation in the stringency of clinical review both at the level of notified bodies and the competent authority level is not optimal to guarantee patient safety in a uniform way for EU citizens,” the authors state. They are also critical for weak wording of the directives and guidance documents when it come to clinical investigation requirements.

They add the argument that conducting clinical trials is too high a hurdle for small companies lacking clinical expertise and financial support is insufficient when confronted with patients’ safety and expectations for effective treatments.

The authors state that for innovative high-risk devices, the future of EU Medical Device Directives should move away from requiring “device performance” data only to also require pre-market data that demonstrate “clinical efficacy or effectiveness.”

Authors are even sceptical about the risk-benefit argument. “The current requirement in the regulation to evaluate ratio already seems to be in consideration with the current absence of controlled assessment of clinical benefit (efficacy) and clinical safety,” they say.

The authors would like to see the following points included in the recast:

• The new pre-market procedure should result in an approved indication for the device and a publicly available product documentation including the full result of the trials. This transparency is required to allow physicians to practice evidence-based medicine, patients to an informed decision and HTA agencies to produce the correct assessment;
• Guidance documents for pre-market clinical trials by type of high-risk device need to be developed. HTA agencies should also be involved in this activity; and
• Payer in Europe should consider, as is the case in the US, co-financing of innovative high-risk devices used in pre-market clinical trials.

The authors also offer transient solutions at member state level. They suggest the while awaiting a reworked Medical Device Directive, patient risk should be minimised at the member state level by improving transparency with regard to the available clinical data and by limiting the market introduction of novel high-risk devices with minimal clinical data to centres with necessary expertise.

Preferably, this should be done under an appropriate protocol (RCT if possible), they say, and requires the commitment of the competent authorities, the marketing company, the physicians and the hospitals.

They also propose that the ethical issues associated with the early market introduction of innovative high-risk devices should be studied further by the commissions and organisations that provide ethical guidance to the physicians and hospitals.

The European Commission, as it considers this document in the context of its work on the recast of the medical device directives, will probably wish that it had the opportunity to consider the text at more length. Will the arguments be convincing enough to result in the centralized pre-market evaluation of high-risk devices? Given that there has already been considerable debate in this area, this report could well be the final weight needed to tip the scale in the balance of such an outcome.

In a draft guidance document, the agency has listed 30 different device types that it intends to exempt from 510(k) notification requirements through the appropriate regulatory processes.

Stakeholders had until October 2011 to submit feedback on the guidance, which includes devices for which FDA believes that a less stringent oversight would not compromise public health and safety. These include common urine and blood tests, alcohol breath tests, blood clotting protein tests and radiology device accessories such as film cassettes, film processors and digitisers.

The majority of devices listed in the guidance document are currently medium risk (class II) or low risk (class I), with respect to class II devices, the FDA intends to propose their down-classification and exemption from the 510(k) review, while class I devices it will propose an amendment to the classification regulations to exempt these devices from the 510(k) requirements.

These devices, however, would be still subjected to other requirements such as those pertaining to labelling, good manufacturing practises, and medical device reporting.

Until the FDA proposes and finalises such down-classification and exemption, it will exercise enforcement discretion with regard to 510(k) submission requirements for these devices.

This means the FDA do not intend to enforce the 510(k) requirements with respect to the devices listed in the guidance document provided that they do not exceed the limitations on exemption specified in the classification regulations.

To view the draft guidance document, visit the FDA website. For assistance obtaining US FDA clearance, contact KD&A.

The proposed regulation sets out conditions under which instructions for use in paper format may be replaced by electronic versions with respect to medical devices that are intended for exclusive use by professionals users and for which use by other persons is not reasonably foreseen.

While acknowledging the benefits of e-labelling, the commission states that the possibility of providing instructions for use in electronic form instead of paper should be limited to certain medical devices and accessories intended to be used in specific conditions.

For reasons of safety and efficiency the draft regulation indicates that medical device users should always have the option of obtaining the instructions for use in paper form on request. The regulation also includes several other procedural safe guards. For example, it requires manufacturers to carry out a documented risk assessment to ensure the appropriateness of providing electronic instructions. This risk assessment should, among other things, demonstrate that providing electronic instructions maintains or improves the level of safety achieved by providing the instructions for use in paper form. The risk assessment will need to be updated in view of experience gained in the post market phase.

The proposed regulation states that electronic instructions for use should be available through a website to ensure unconditional access and to facilitate the communication of updates and product alerts. Regardless of the language related legal obligations imposed by EU member states, the regulations state that manufacturer should indicate on their website in which EU languages the electronic instructions for use are available.

Except for class I medical devices, the commission believes that the fulfilment of obligations laid out in the regulation should be reviewed by a notified body. The draft regulation lists the devices for which electronic instructions for use can be provided.

When finalised, the regulation will be published in the Official Journal and is expected to come into force one year after the publication date.

For a copy of the draft regulation can be found at the European Commission website. Contact KD&A for assistance to establish e-labelling for your medical device.

Proposal 1: The reclassification of load bearing joints – class IIb to class III

The TGA have decided to implement this proposal based on data obtained from the Australian National Joint Replacement Registry (NJRR). This change will take place via amendment to the Therapeutic Goods (Medical Device) Regulations 2002 and will include a 2 year transition period commencing 1 July 2012. Sponsors of existing class IIb devices will need to submit new device applications to include their product(s) as class III devices and will of course require the supporting certification (CE Marking and Design Examination certificates). The TGA will not complete application audits on these submitted device applications to ensure uninterrupted access to applicable devices.  Finally in an unprecedented move, the TGA will waive the device application fee if the application is submitted within the first year of the transition period (before July 1 2013), encouraging manufacturers to update requirements sooner.

Proposal 2: Third party assessment bodies and implantable medical devices

This proposal included use of third party assessment bodies for Australian manufacturers, an increase of post market security for implantable medical devices, and a confidence building and recognition of third party assessment bodies. The TGA have advised this proposal remains under consideration and further consultation will occur, a somewhat disappointing result for Australian manufacturers.

Proposal 3(i): The way in which medical devices are included on the ARTG

The TGA will implement the proposal to include product name details in ARTG inclusions. The proposal, designed to improve TGA’s ability to quickly identify and recall medical devices, will be implemented again through amendment to the Therapeutic Goods (Medical Device) Regulations 2002. All ARTG inclusions will need to include product name details (product model number or trade name) and will be subject to a transition period of 2 years commencing 1 July 2012.  The TGA have advised that they will also consider imposing conditions on all ARTG entries to ensure information included is suitably maintained. At this stage it is not clear how the TGA require sponsors to make the updates. The TGA have advised that guidance regarding product name details will be released and notifications to sponsors will be provided.

Proposal 3(ii): Enhance the ability to identify devices that have been approved by the TGA

The TGA have advised this proposal is being met by the actions described above relating to proposal 3(i). The TGA acknowledge the negative reaction from respondents to the proposal based on fears of associated costs and the requirement to have Australian-only product lines.

Proposal 4: Publication of device product information on the TGA’s website

In an attempt to improve transparency and accountability of its decision making process, the TGA have advised they intend to increase the level of publicised information on their website. A decision met with mixed reaction from proposal respondents. It is hoped this reform will bring a new level of understanding of the TGA’s review processes.

KD&A will closely monitor the status of these reforms and can assist your organisation to prepare and complete required changes at any stage. The reforms, whilst in their infancy now will require action from almost all medical device sponsors with varying degrees of regulatory burden. Our advice for now….consider the new requirements, be vigilant, and stay tuned.

For further detail on the TGA released information visit: Reforms to the medical devices regulatory framework: proposals

Please contact KD&A for further details.