www.medtechreview.com email@example.com[slide 1]Thank you Scott for your kind introduction. You and I have worked side byside, as partners, over the past eleven years. Together, we have seen thecontinued growth of China’s medical device manufacturing sector and strive tokeep industry well informed on regulatory requirements. We have seen newregulations established by SFDA. Moreover, we have seen the US FDA increaseinspection and enforcement activities throughout China. We have participatedin the US-China joint meetings as advisors and I am so very glad to be able toparticipate once again with you as a presenter to Medtec China 2011.[slide 2]In my presentation today, I provide to you an introduction of the US FDA’sElectronic Submission Gateway, or ESG. This includes an overview of allelectronic submissions that FDA accepts from all industries they regulate. Mostimportantly, I will focus on the initiatives of the Agency’s Center for Devicesand Radiological Health, or CDRH by introducing to you the electronicsubmissions of Medical Device Reports, or eMDR. The proposed regulation wasintroduced in 2006 and will soon become final regulation (the expectations arethe final regulations will be issued by the end of 2011). Finally, I have a 10-minute video clip of the June 2011 FDA webinar on the use of the eSubmitter
www.medtechreview.com firstname.lastname@example.org WebTrader software which discussing some of the details you, as a medicaldevice manufacturer, must know in order to comply with the new regulations.[slide 3]Since beginning my career in the medical device sector, I have often seen manyregulations misunderstood. The misunderstandings remind me of a lady I onceknew who was visiting Shanghai for the first time. During her tour of this greatcity, she becomes very hungry. With an empty belly and with high confidence,she enters a local restaurant seeking some delicious meal to eat. She noticesthe Chinese characters on the restaurant menu while eating her lunch. Whilestaring at these Chinese characters on the menu, she thinks to herself howbeautiful and interesting these characters are … she is really quite fascinated;so, she copies them down as best she can and when she goes home she printsthem out and makes a t-shirt with the characters on it. Later that day, shebumps into a Chinese person. The person looks at her and says, "Do you knowwhat your shirt says?" The lady admits that she doesnt know … this is the shirtthe lady has made for herself[slide 4](Pause) and lady asks the Chinese person to translate her shirt. The man says,"Your shirt says cheap but good."
www.medtechreview.com email@example.com[slide 5]Misunderstandings and information are the key topics in today’s presentation.The business between you (in this audience) and the Food and DrugAdministration (FDA) is extremely information intensive. There exists, at times,too much information that easily leads to misunderstandings. What we read,and put together (like a jig-saw puzzle) can lead to troublesome situations suchas the lady in the story.In recognition of the fact that FDA is extremely information intensive, and ofthe potential benefits offered by technology for information management, theFDA has undertaken a number of projects supporting the electronic submissionof text and data from the industries it regulates.[slide 6]Electronic submissions, or eSubmissions, began in September 1997 withComputer Assisted New Drug Applications (CANDA). From 1999 through 2001,FDA’s various Centers began the publication of guidance documents such as“Providing Regulatory eSubmissions for NDAs, BLA, ANDAs”. And, in the years2006 and 2007 the medical device center, FDA’s CDRH, developed e-copyinitiatives and the turbo 510(k)s for In Vitro Diagnostic device submissions.
www.medtechreview.com firstname.lastname@example.orgThe most recent activities of the Agency include the eMDR (Adverse EventReporting) and the mandatory use of FURLS (Electronic Registration and ListingSystem) and DRLM (Device Registration and Listing Module). Despite the movetoward eSubmissions, the various Centers within FDA are debating on theplatform for providing electronic data to the Agency.[slide 7]The use of STDM, or statistical time division multiplexing, versus HL7, theglobal authority on standards for interoperability of health informationtechnology, is under debate and has considerably slowed full implementationof electronic submissions at FDA. None-the-less, electronic submissions areexpected in the coming months and China’s healthcare product manufacturersneed to stay aware of the requirements; else they will find more confusion,delays in getting their products to America and trouble with FDA wheneventually the Investigators come for inspections.Regardless of the debates, one of the main projects FDA has implemented isthe establishment of an Agency-wide solution for accepting electronicregulatory submissions, referred to as the FDA Electronic Submissions Gateway(FDA ESG)1.1 Federal Register: August 8, 2006 (Volume 71, Number 152).
www.medtechreview.com email@example.com[slide 8]The Gateway (ESG) enables the submission of regulatory information forreview. The overall purpose of the Gateway (ESG) is to provide a centralized,agency-wide communications point for securely receiving electronic regulatorysubmissions. The Gateway (ESG) enables the FDA to process regulatoryinformation through automated mechanisms while also enabling: • A single point of entry for receiving and processing all electronic submissions in a highly secure environment, • Automating current processes such as the electronic acknowledgment of submissions, and • Supporting the electronic Common Technical Document (eCTD) – something familiar to those of you in the pharmaceutical sector.The number of electronic submissions over the years is the best measurementof the FDA’s success with the Gateway. The number of submissions has grownexponentially as shown in this chart.[slide 9]
www.medtechreview.com firstname.lastname@example.orgEach FDA Center has decided what may be submitted to them electronically.Currently, Adverse Events represent 72% (almost three-quarters) of the totalelectronic submissions to FDA, while premarket submissions for Devicesrepresents 12%, premarket applications for Drugs represents 9.5%, andpremarket applications for Biologics represent less than 1%. The methods ofelectronic submissions vary by Center and guidelines for the proper electronicsubmissions are published by each Center within the FDA. There is very littleharmonization.[slide 10]So what does FDA accept as electronic submissions? The answer varies byCenters and this slide tells you the current electronic submissions accepted byFDA by the various Centers.
www.medtechreview.com email@example.comConsider, for example, the reporting of Adverse Events that are accepted byCBER (the Center for Biologics), CDER (the Center for Drugs) and CDRH (theCenter for Devices). All use the Agency’s Electronic Submissions Gateway, butsetting up your company to submit to the different Centers are all doneaccording to the different guidelines published by those Centers. For example,the FDA provides to drug and therapeutic biological product manufacturers,
www.medtechreview.com firstname.lastname@example.org, packers, and other interested parties the instructions on how toelectronically submit postmarketing individual case safety reports (ICSRs),either with and without relevant attachments. Now, compare this with theCenter for Devices and Radiologic Health (CDRH) who have introduced theelectronic Medical Device Reporting (eMDR) project that provides the capabilityfor electronic data entry and processing of medical device adverse eventreports using two methods (server to server or via the World Wide Web).[slide 11]Consider a product that is regulated both as a drug and a device (of course thisexists and the situation is dependent on the product’s intended use). Theproper reporting, through the programs and Gateway setup by FDA, might beconfusing - unless the regulatory affairs responsible person at your companymaintains their competency.This year’s Medtech China regulatory forum, as well as my presentation, isdesigned to make you aware about such programs. However, in the shortamount of time I have for this presentation, I can only inform you on thedifferences between Centers at the FDA so that you have the chance to besuccessful in your own research and use of the FDA’s electronic programs.However, I invite you to contact me directly if you need personal assistance.
www.medtechreview.com email@example.com[slide 12]The FDA Electronic Submission GATEWAY is an electronic submission processthat is defined as the receipt, acknowledgment, routing, and notification to areceiving Center (within FDA) of the receipt of your electronic submission. Inthis definition, • "Receipt" means transfer of a submission from a sender’s system to a temporary storage area in the GATEWAY (FDA ESG). • "Acknowledgment" to the sender that the submission was sent from the sender’s system and received by the Gateway. • "Routing" refers to delivering a submission to a Center-level storage area and initiating a load process to place a submission into a Center receiving system • "Notification" of a submission’s arrival is made to those individuals responsible for the Center’s receiving system.Each of these terms denotes a step in the process of electronic submissiondelivery, and together, these steps comprise the whole scope of electronicsubmission delivery.[slide 13]
www.medtechreview.com firstname.lastname@example.orgThe FDA Electronic Submission Gateway is the central transmission point forsending information electronically to the FDA. Within that context, theGateway is a conduit, or "highway", along which submissions travel to reachtheir final destination. The system does not open or review submissions; itmerely routes them to the proper destination. And one other important fact isthat the FDA Electronic Submissions Gateway uses a software applicationcertified to comply with secure messaging standards.As described so far, I am sure you are telling yourself this should be relativeeasy (I mean, after all, isn’t the whole process suppose to make submissionseasier for everyone?). Officials at AGA Medical – a client of MedTech Reviewand one of FDA’s first low-volume electronic reporters – can attest that it’s notpossible to get an eMDR program up and running in the blink of an eye. It tookthe company six to eight weeks to complete the appropriate testing andtraining of staff before it officially began sending eMDRs. Choosing to submiteMDRs to FDA – even though it’s not mandatory – was a no-brainer for AGAMedical once it realized that it was “faster, much more accurate and muchcheaper” than sending paper MedWatch reports.[slide 14]Using the eMDR program “is less expensive. The company doesn’t have to put a
www.medtechreview.com email@example.com on an envelope, or spend $10 to $15 for a FedEx package to get to FDA.”“Second, it’s more accurate, because what the company renders on the MDRforms doesn’t require FDA’s contractor to print things out and retype them in,so the company doesn’t have to worry about transcription errors.“Third, it’s faster. Generally, when the company pushes the button to transmitthings they’ll get a response back in 10 minutes or less that says it’s beenloaded into FDA’s database.” “And then if the company needs to do theirreconciliations of what has been submitted versus what FDA has received, thecompany can verify for the [agency investigator] or their internal auditors thatthey actually have submitted that information. “And, of course, everybody willhave to get there eventually anyway, so go ahead and do it now.”[slide 15]What’s in it for you?Collaboration: The entire concept behind the electronic submission tool is toenhance the collaboration between an organisation and the FDA. The agency’sgoal is to not only provide an environment for easy and seamless submission ofadverse events, but to also speed up the time in which it is able to respond toevents. The tools also enhance the communication process with the FDA andeliminates or reduces “crossover emails”. Those who use the electronic willbenefit from an immediate receipt and acknowledgement – within six to 12
www.medtechreview.com firstname.lastname@example.org – as opposed to waiting days or longer with the manual reportingprocess.Cost reduction: Use of the electronic tools will result in cost savings, as it willeliminate the need for the administrative overhead incurred from traditionalcommunication. Through the use of batch event reporting, and immediateinteraction with the FDA, companies can literally “upload” multiple adverseevents in a single click to the FDA, saving time and resources in the process.Record retention: One of the major challenges with the traditional MedWatchforms is that they are recorded on paper. These manual processes require a lotof paperwork and the forms usually end up in a filing cabinet or file server andcan take a long time to even locate. With the electronic submission, oldrecords will be able to be retrieved in real time, as everything is automatedand centrally stored in a data repository. Similarly, all related documentationis available at the click of a button. For example, the electronic toolsautomatically link the FDA’s acknowledgement to the original submission,eliminating any confusion as to which acknowledgements belong with whichsubmissions. This provides complete transparency and accuracy of correlatingdata and results in an efficient and reliable process.Responsiveness: The electronic tool will enable involved parties to flag
www.medtechreview.com email@example.com errors quickly, as opposed to the more manual and time-consumingcorrespondences to and from the FDA. This allows for the efficient and real-time response to all events from the agency. Furthermore, the electronic toolsprovide a collaborative environment between companies and the FDA toproactively review and correct errors and respond to questions. In the case ofmajor adverse events, time is a critical factor in responding to the market, andelectronic tools allow for significantly reduced response time from the FDA.Single environment for all adverse events: Technology is all about theconsolidation of systems and providing a comprehensive, enterprise method forstoring data. Much like any business systems integration, the electronic toolsare designed to provide a holistic environment for all regulatory submissions.They act as a single point of entry for processing all electronic submissions in ahighly secure environment. This is beneficial because complaints to thecompany can be directly linked to a MedWatch form and integrated with theFDA’s gateway. Within a single environment, companies can store not onlytheir internal compliance data, but also any FDA responses to the originalevent. Complaints or adverse event data can also be linked to product lines inexternal systems such as enterprise resource planning, customer relationshipmanagement and laboratory information management systems, providingmultiple points of data throughout the business.
www.medtechreview.com firstname.lastname@example.org[slide 16]Preparing for ESG is not for the faint of heartMost likely you are the Compliance Officer or at the very least an ITrepresentative, with little or no experience in Public Key Infrastructure, theunderlying policy and technology utilized behind digital certificates, let alonefamiliar with terms like .cer and PKCS12 abundantly referenced in FDA ESGuser guides. ESG readiness includes numerous steps ranging from installing andconfiguring Sun’s Java Runtime plug-ins to submitting letters of non-repudiation needed to comply with 21 CFR part 11. Acquiring and preparingx.509v 3 digital certificates to authenticate and sign submissions through theESG is just one of several readiness tasks that separate you from being able tomove from costly and slow paper intensive submissions to the speed andefficiency of electronic submissions.[slide 17]Getting started with the FDA’s electronic submissions gateway.Prior to registering for an ESG account, one must determine which submissionoption to use, the FDA ESG Web Interface (WebTrader) or the AS2 Gateway-to-Gateway. This determination is based on types of submissions to betransmitted, infrastructure capabilities and business considerations. TheWebTrader is the low-cost option and has fewer set-up requirements than the
www.medtechreview.com email@example.comGateway- to-Gateway option. During the 2009 implementation, manycompanies found that establishing their accounts was more time-consumingthan they had envisaged. Time to setup accounts are now reported as four toeight months for establishing and testing WebTrader accounts.Several preparatory activities precede the formal request to the FDA. 1. Procure a DUNS number for your establishment if required (one DUNS number per address). 2. Set up a digital certificate. The digital certificate is required in order to use an electronic signature and provides authentication, confidentiality, integrity, and non-repudiation of data. 3. Prepare an electronic submission. This submission does not need to be guidance- compliant (the submission will not be reviewed by the FDA), but should be representative of the file types that would be submitted in a typical submission (ie, a mixture of PDF, text files, MS Word files, etc.). 4. Set up the computer system that will do the submissions through ESG; the operating system should be Windows XP and the Java SE runtime environment (JRE) 5.0. You will need a browser; ESG is compliant with Internet Explorer 6, 7, 8 or Firefox 2.0.x. The digital certificate and WebTrader account are specific for the computer on which they are set
www.medtechreview.com firstname.lastname@example.org up. 5. Once the DUNS number is available, the digital certificate is set up, and the computer is configured, submit a Letter of Non- Repudiation to two separate locations within the FDA. Submit these letters in paper form, on company letterhead, and signed with a traditional handwritten signature. The letter certifies that the electronic signature is the legally binding equivalent of a traditional handwritten signature.Lastly, the electronic Medical Device Report (eMDR) application uses the HealthLevel Seven (HL7) ICSR standard for the reports. Two options for preparingeMDRs are available: 1. FDA eSubmitter (formerly CeSub), a free downloadable application, allows submission of eMDR reports one at a time for low volume reporters. The eSubmitter contains data elements of the MedWatch Form 3500A which are manually entered and then packaged as an HL7 ICSR message. 2. High volume and frequent reporters do not require the eSubmitter. The eMDRs are created directly from adverse event information in the reporter’s system and formatted as a HL7 ICSR.
www.medtechreview.com email@example.comI have edited a 2-hour web-training course that was presented by FDA this June2011 as part of this presentation, which I will show to you now. This smallexcerpt reiterates the commitment of FDA to mandatory electronic submissionsof Medical Device Reports and speaks in more detail about some of the itemsyou, the China medical device manufacturer, must consider as you plan andestablish your electronic system to communicate with FDA.[play movie clip]