Instructions for Use (IFU) - On the manufacturer's website vs. On the product label

[quest]

Does the FDA and/or EU allow a manufacturer to state on a label that IFU can be found on the manufacturer's website? This would be instead of including the IFU with the product. Do you know where I can find info on this subject?

[Al Rosen]

Originally Posted by quest

Does the FDA and/or EU allow a manufacturer to state on a label that IFU can be found on the manufacturer's website? This would be instead of including the IFU with the product. Do you know where I can find info on this subject?

I'm assuming this is a medical device. It's not acceptable. The basis is that the user must have access to the instructions. If he does not have access to the website he does not have the IFU. If this is a prescription device there are other considerations.

[quest]

Thank you for your input. We are considering printing the necessary information in English on the packaging and would reference the website for other languages. Would this be acceptable? Is there guidance anywhere on the labeling of domestic vs international products? You state that making the IFU available on the website only is unacceptable. Is this stated in the MDD? How about GMP? Thank you in advance for any info on this subject.

[Al Rosen]

Originally Posted by quest

Thank you for your input. We are considering printing the necessary information in English on the packaging and would reference the website for other languages. Would this be acceptable? Is there guidance anywhere on the labeling of domestic vs international products? You state that making the IFU available on the website only is unacceptable. Is this stated in the MDD? How about GMP? Thank you in advance for any info on this subject.

Although, the MDD is a requirement in the EU for each country or state, this is one requirement that the individual countries have as far as the languages required for IFU. If you are marketing in the EU, then you should check each country's requirements. That is each country that you will be selling in. I posted the language requirements in another thread. Also look at this thread.

[quest]

Thanks again. As always, this forum is extremely helpful expecially to novices like myself. It has been a tremendous source of information. What about the FDA? Can we reference our website as the location of the directions for use and cleaning recommendations for the devices shipped within the US?

[Al Rosen]

Originally Posted by quest

Thanks again. As always, this forum is extremely helpful expecially to novices like myself. It has been a tremendous source of information. What about the FDA? Can we reference our website as the location of the directions for use and cleaning recommendations for the devices shipped within the US?

As always it depends and I don't have enough information to determine that. I think the answer can be found here.
From FDA Blue Book Memo #G03-1

Section 206 of MDUFMA amended Section 502(f) of the Federal Food, Drug, and Cosmetic Act (the Act) to authorize the use of electronic labeling, rather than the traditional paper labeling, under specified circumstances. Upon enactment, distributors of prescription devices who intend those devices to be used within the confines of a health care facility may provide labeling for those devices solely in electronic form, so long as they afford users the opportunity to request the labeling in paper form and promptly provide such labeling to requestors without additional cost.

[quest]

I just read the Public Consultation Text of the proposed new MDD and see that they have added into Annex I, a paragraph 13.7 that states, The commission, in accordance with the procedure referred to in Article 7 (2) may, where duly justified, adopt measures allowing instructions for use to be provided by other means.
If the MDD is approved as is, what exactly does this mean? Does the manufacturer need to do anything other than update internal docs, technical file, etc? Does one need to petition the EC to use 'E' solutions for IFU's?

[Al Rosen]

Originally Posted by quest

I just read the Public Consultation Text of the proposed new MDD and see that they have added into Annex I, a paragraph 13.7 that states, The commission, in accordance with the procedure referred to in Article 7 (2) may, where duly justified, adopt measures allowing instructions for use to be provided by other means.
If the MDD is approved as is, what exactly does this mean? Does the manufacturer need to do anything other than update internal docs, technical file, etc? Does one need to petition the EC to use 'E' solutions for IFU's?

From the August 2005 issue of RAPS Focus Magazine article, The EU Commission’s Draft Medical Devices Directive
By Linda Horton and Matthew Giles

E-labeling
The amended Directive opens the way for instructions in electronic rather than paper format, via electronic labeling. The mention of “leaflet” in the current MDD has impeded use of e-labeling despite its obvious practical benefits, i.e., dealing with 20 official languages, limited space and reduction of paper waste. The draft does not explicitly permit e-labeling but it allows the Commission, where justified, to “adopt measures allowing instructions for use to be provided by other means.”

In the same issue, there is more about it in the article, Medical Device Users Receptive to E-labeling
By Jeanette Merchant

The additional language requirements for medical devices in the enlarged European Union are driving the search for acceptable alternatives to paper leaflets as a means to provide information for the safe and correct use of devices to professional end users.
Instructions for Use (IFU), which are mandatory for all medical devices except those in Class I and IIa, are now required to be provided in 19 languages in the recently expanded EU (although the number of official languages has increased to 20, Malta accepts IFU in English). This almost doubles the size and volume of the paper IFU and entails revision of some packaging designs to accommodate the additional language requirements. Not only does this translate into increased transport and storage costs, but adds to the environmental problem of paper waste.
Electronic labeling could provide the ideal solution by enabling medical device manufacturers to provide instructions to professional end users on an electronic support. This could be a CD-ROM or PDF document that could be downloaded from the Internet or a built-in screen that displays the IFU in the operator’s language while the device, such as a pacemaker, operates.
In its current form, the Medical Devices Directive (MDD) does not provide a clear regulatory pathway to e-labeling, since it refers to a “leaflet” and requires medical devices to be accompanied by the IFU. However, revisions to the MDD currently under review would open the door to e-labeling. The European Commission has proposed that the IFU could be provided in a form other than paper and, according to John Brennan, principal administrator at the Directorate General Enterprise, the Commission does not understand member states’ reluctance to permit e-labeling.
Although many member states support the concept of e-labeling, Germany, Belgium, Greece, Sweden and the Netherlands are among those that have not embraced the idea. There is reluctance among Competent Authorities about use of the Internet, in particular, since it raises issues of accessibility and also implies a shift in responsibility from the manufacturer to the user, who would have to actively obtain the IFU.
The results of surveys conducted by industry and regulators to gauge the views of professional users indicate that CD-ROMs could be the way forward in gaining acceptance of e-labeling. A European pilot study by Medtronic in 2004 found that a surprisingly large number of doctors are receptive to CD-ROM manuals. Of the 637 implanting physicians in 11 EU countries who participated in the survey, 35% said they preferred CD manuals for implants (namely, pacemakers and defibrillators) to paper manuals and 28% regarded them as equivalent and did not mind which was provided. Just 4% of doctors surveyed would not accept CDs and required paper manuals. There were no significant differences between countries.
The conclusions from Medtronic’s survey are more positive in some aspects than the results of an opinion survey carried out by the German Federal Institute for Drugs and Medical Devices (BfArM) in March 2004. Although the 14 German medical societies, hospital federations and professional associations that participated in the survey believed there were advantages with electronic labeling, BfArM concluded that the majority of professional users will require a paper version of the IFU for every type of medical device in addition to an electronic manual, which is regarded as a supplement to, rather than a replacement of the conventional version.
CD-ROMs are much more widely accepted by German professional users as an electronic medium than the Internet or device-integrated screens, according to the BfArM survey. The main advantage of e-labeling is perceived to be the availability of up-to-date information. New electronic technology tools, such as computer animation or live-case video, are also regarded as enhancing doctors’ understanding of the IFU. Other advantages of electronic media cited by professional users included key word search tools and easy storage, filing and processing.
Management of electronic data could pose problems, such as failure to find the latest CD, while concerns were also raised about technical reliability and data integrity. Access to an electronic IFU will be limited by the
availability of the necessary computer equipment in the healthcare facility or location within the hospital where the medical device is being used—hence the need for a paper version.
Half the German respondents in the BfArM survey thought that e-labeling could be used for any type of medical device, whereas the other half considered it most appropriate for active devices and not for single-use products. There is strong endorsement of e-labeling for in vitro diagnostic devices: “As the responses of the organizations representing users of in vitro diagnostic medical devices are extremely positive, in vitro diagnostic medical devices for use by professional laboratories may probably be considered separately,” concluded BfArM.
There is more flexibility in the potential for e-labeling in the IVD sector. The language of the IVD Directive is less restrictive than the MDD in that IFUs are required to accompany the device or be included in the packaging, without specifying that this must be a paper form. Furthermore, the European Diagnostic Manufacturers Association has concluded that software intended to guide the user via the monitor cannot be regarded as a label or instruction for use in the meaning of the IVDD. The industry has, therefore, concluded that text displayed on screens could be provided in any language.
Surveys such as that carried out by Medtronic are contributing to a better understanding of customer requirements and the risk benefits of providing electronic manuals. Information derived from medical professionals lends more weight to industry’s arguments that e-labeling should be used only with medical devices intended to be used or handled by professionals in healthcare facilities and that information provided electronically must be easily read using software formats commonly available on a standard PC.
As a precursor to building the case for e-labeling, physicians’ needs and requirements must be assessed. Other companies, including implant manufacturers and the suture industry, are considering following Medtronic’s lead in soliciting the views of their European customers. If surveys can demonstrate the advantages of e-labeling to professional users without compromising patient safety, such information will help to overcome regulators’ concerns about e-labeling in Europe.
US Experience
Experience with e-labeling in the US is also fueling the European industry’s drive to prepare the ground for alternatives to paper manuals. Authorized under the provisions of the Medical Device User Fee and Modernization Act ( MDUFMA) which was signed into law in October 2002, e-labeling is permitted for prescription devices intended for use in a healthcare facility. Paper copies of the labeling must be provided on request. Electronic labeling is not restricted to a particular technology, so the Internet can be used as well as CD-ROMs.
Electronic labeling must be provided to the Food and Drug Administration (FDA) during product submission review. One key benefit is that any labeling changes required by FDA can be made immediately, reducing delays in getting the device to market, according to Dr. Tom van der Schatte Olivier, director of regulatory affairs of Cordis’ European business. During Eucomed’s Technical Forum in September 2004, he reviewed the company’s experience with e-labeling for its drug-eluting Cypher stent, which was launched in the US in April 2003.
Cordis initially provided electronic labeling for Cypher through a dedicated website (Cypherusa.com) although a new site was launched in the fall of 2004 to accommodate more than one product. It is important to differentiate between promotional/educational material and the IFU, he noted. While there are many benefits associated with e-labeling, the process requires dedicated resources, including in-house staff who have validation expertise, including software validation. Access to the website must be controlled and differences in products and regulatory status in different countries/regions must be addressed. Restricted Internet access is a potential problem, although this may not be the case in 10 years’ time.
E-labeling does not totally obviate the need for paper copies. Cordis has received 1,175 requests a year for printed material since Cypher was released. Nevertheless, based upon the success of its experience with the Cypher website, with just two complaints regarding e-labeling out of more than 750,000 Cypher stents sold in the US, the company is committed to e-labeling and is working on enhancements for 2005. “A strong business case and risk assessment are essential,” according to van der Schatte Olivier.