Electronic Submissions Speech

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[slide 1]

Thank you Scott for your kind introduction. You and I have worked side by

side, as partners, over the past eleven years. Together, we have seen the

continued growth of China’s medical device manufacturing sector and strive to

keep industry well informed on regulatory requirements. We have seen new

regulations established by SFDA. Moreover, we have seen the US FDA increase

inspection and enforcement activities throughout China. We have participated

in the US-China joint meetings as advisors and I am so very glad to be able to

participate 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’s

Electronic Submission Gateway, or ESG. This includes an overview of all

electronic submissions that FDA accepts from all industries they regulate. Most

importantly, I will focus on the initiatives of the Agency’s Center for Devices

and Radiological Health, or CDRH by introducing to you the electronic

submissions of Medical Device Reports, or eMDR. The proposed regulation was

introduced in 2006 and will soon become final regulation (the expectations are

the 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


and WebTrader software which discussing some of the details you, as a medical

device 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 many

regulations misunderstood. The misunderstandings remind me of a lady I once

knew who was visiting Shanghai for the first time. During her tour of this great

city, she becomes very hungry. With an empty belly and with high confidence,

she enters a local restaurant seeking some delicious meal to eat. She notices

the Chinese characters on the restaurant menu while eating her lunch. While

staring at these Chinese characters on the menu, she thinks to herself how

beautiful 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 prints

them out and makes a t-shirt with the characters on it. Later that day, she

bumps into a Chinese person. The person looks at her and says, "Do you know

what your shirt says?" The lady admits that she doesn't know … this is the shirt

the 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'."


[slide 5]

Misunderstandings and information are the key topics in today’s presentation.

The business between you (in this audience) and the Food and Drug

Administration (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 such

as the lady in the story.

In recognition of the fact that FDA is extremely information intensive, and of

the potential benefits offered by technology for information management, the

FDA has undertaken a number of projects supporting the electronic submission

of text and data from the industries it regulates.

[slide 6]

Electronic submissions, or eSubmissions, began in September 1997 with

Computer 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 years

2006 and 2007 the medical device center, FDA’s CDRH, developed e-copy

initiatives and the turbo 510(k)s for In Vitro Diagnostic device submissions.


The most recent activities of the Agency include the eMDR (Adverse Event

Reporting) and the mandatory use of FURLS (Electronic Registration and Listing

System) and DRLM (Device Registration and Listing Module). Despite the move

toward eSubmissions, the various Centers within FDA are debating on the

platform for providing electronic data to the Agency.

[slide 7]

The use of STDM, or statistical time division multiplexing, versus HL7, the

global authority on standards for interoperability of health information

technology, is under debate and has considerably slowed full implementation

of electronic submissions at FDA. None-the-less, electronic submissions are

expected in the coming months and China’s healthcare product manufacturers

need to stay aware of the requirements; else they will find more confusion,

delays in getting their products to America and trouble with FDA when

eventually the Investigators come for inspections.

Regardless of the debates, one of the main projects FDA has implemented is

the establishment of an Agency-wide solution for accepting electronic

regulatory submissions, referred to as the FDA Electronic Submissions Gateway

(FDA ESG)1.

1
Federal Register: August 8, 2006 (Volume 71, Number 152).


[slide 8]

The Gateway (ESG) enables the submission of regulatory information for

review. The overall purpose of the Gateway (ESG) is to provide a centralized,

agency-wide communications point for securely receiving electronic regulatory

submissions. The Gateway (ESG) enables the FDA to process regulatory

information 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 measurement

of the FDA’s success with the Gateway. The number of submissions has grown

exponentially as shown in this chart.

[slide 9]


Each FDA Center has decided what may be submitted to them electronically.

Currently, Adverse Events represent 72% (almost three-quarters) of the total

electronic submissions to FDA, while premarket submissions for Devices

represents 12%, premarket applications for Drugs represents 9.5%, and

premarket applications for Biologics represent less than 1%. The methods of

electronic submissions vary by Center and guidelines for the proper electronic

submissions are published by each Center within the FDA. There is very little

harmonization.

[slide 10]

So what does FDA accept as electronic submissions? The answer varies by

Centers and this slide tells you the current electronic submissions accepted by

FDA by the various Centers.


Consider, for example, the reporting of Adverse Events that are accepted by

CBER (the Center for Biologics), CDER (the Center for Drugs) and CDRH (the

Center for Devices). All use the Agency’s Electronic Submissions Gateway, but

setting up your company to submit to the different Centers are all done

according to the different guidelines published by those Centers. For example,

the FDA provides to drug and therapeutic biological product manufacturers,


distributors, packers, and other interested parties the instructions on how to

electronically submit postmarketing individual case safety reports (ICSRs),

either with and without relevant attachments. Now, compare this with the

Center for Devices and Radiologic Health (CDRH) who have introduced the

electronic Medical Device Reporting (eMDR) project that provides the capability

for electronic data entry and processing of medical device adverse event

reports 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 this

exists and the situation is dependent on the product’s intended use). The

proper reporting, through the programs and Gateway setup by FDA, might be

confusing - unless the regulatory affairs responsible person at your company

maintains their competency.

This year’s Medtech China regulatory forum, as well as my presentation, is

designed to make you aware about such programs. However, in the short

amount of time I have for this presentation, I can only inform you on the

differences between Centers at the FDA so that you have the chance to be

successful 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.


[slide 12]

The FDA Electronic Submission GATEWAY is an electronic submission process

that is defined as the receipt, acknowledgment, routing, and notification to a

receiving Center (within FDA) of the receipt of your electronic submission. In

this 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 submission

delivery, and together, these steps comprise the whole scope of electronic

submission delivery.

[slide 13]


The FDA Electronic Submission Gateway is the central transmission point for

sending information electronically to the FDA. Within that context, the

Gateway is a conduit, or "highway", along which submissions travel to reach

their final destination. The system does not open or review submissions; it

merely routes them to the proper destination. And one other important fact is

that the FDA Electronic Submissions Gateway uses a software application

certified to comply with secure messaging standards.

As described so far, I am sure you are telling yourself this should be relative

easy (I mean, after all, isn’t the whole process suppose to make submissions

easier for everyone?). Officials at AGA Medical – a client of MedTech Review

and one of FDA’s first low-volume electronic reporters – can attest that it’s not

possible to get an eMDR program up and running in the blink of an eye. It took

the company six to eight weeks to complete the appropriate testing and

training of staff before it officially began sending eMDRs. Choosing to submit

eMDRs to FDA – even though it’s not mandatory – was a no-brainer for AGA

Medical once it realized that it was “faster, much more accurate and much

cheaper” than sending paper MedWatch reports.

[slide 14]

Using the eMDR program “is less expensive. The company doesn’t have to put a


stamp 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 MDR

forms 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 transmit

things they’ll get a response back in 10 minutes or less that says it’s been

loaded into FDA’s database.” “And then if the company needs to do their

reconciliations of what has been submitted versus what FDA has received, the

company can verify for the [agency investigator] or their internal auditors that

they actually have submitted that information. “And, of course, everybody will

have 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 to

enhance the collaboration between an organisation and the FDA. The agency’s

goal is to not only provide an environment for easy and seamless submission of

adverse events, but to also speed up the time in which it is able to respond to

events. The tools also enhance the communication process with the FDA and

eliminates or reduces “crossover emails”. Those who use the electronic will

benefit from an immediate receipt and acknowledgement – within six to 12


minutes – as opposed to waiting days or longer with the manual reporting

process.

Cost reduction: Use of the electronic tools will result in cost savings, as it will

eliminate the need for the administrative overhead incurred from traditional

communication. Through the use of batch event reporting, and immediate

interaction with the FDA, companies can literally “upload” multiple adverse

events in a single click to the FDA, saving time and resources in the process.

Record retention: One of the major challenges with the traditional MedWatch

forms is that they are recorded on paper. These manual processes require a lot

of paperwork and the forms usually end up in a filing cabinet or file server and

can take a long time to even locate. With the electronic submission, old

records will be able to be retrieved in real time, as everything is automated

and centrally stored in a data repository. Similarly, all related documentation

is available at the click of a button. For example, the electronic tools

automatically link the FDA’s acknowledgement to the original submission,

eliminating any confusion as to which acknowledgements belong with which

submissions. This provides complete transparency and accuracy of correlating

data and results in an efficient and reliable process.

Responsiveness: The electronic tool will enable involved parties to flag


submission errors quickly, as opposed to the more manual and time-consuming

correspondences to and from the FDA. This allows for the efficient and real-

time response to all events from the agency. Furthermore, the electronic tools

provide a collaborative environment between companies and the FDA to

proactively review and correct errors and respond to questions. In the case of

major adverse events, time is a critical factor in responding to the market, and

electronic tools allow for significantly reduced response time from the FDA.

Single environment for all adverse events: Technology is all about the

consolidation of systems and providing a comprehensive, enterprise method for

storing data. Much like any business systems integration, the electronic tools

are designed to provide a holistic environment for all regulatory submissions.

They act as a single point of entry for processing all electronic submissions in a

highly secure environment. This is beneficial because complaints to the

company can be directly linked to a MedWatch form and integrated with the

FDA’s gateway. Within a single environment, companies can store not only

their internal compliance data, but also any FDA responses to the original

event. Complaints or adverse event data can also be linked to product lines in

external systems such as enterprise resource planning, customer relationship

management and laboratory information management systems, providing

multiple points of data throughout the business.


[slide 16]

Preparing for ESG is not for the faint of heart

Most likely you are the Compliance Officer or at the very least an IT

representative, with little or no experience in Public Key Infrastructure, the

underlying policy and technology utilized behind digital certificates, let alone

familiar with terms like .cer and PKCS12 abundantly referenced in FDA ESG

user guides. ESG readiness includes numerous steps ranging from installing and

configuring Sun’s Java Runtime plug-ins to submitting letters of non-

repudiation needed to comply with 21 CFR part 11. Acquiring and preparing

x.509v 3 digital certificates to authenticate and sign submissions through the

ESG is just one of several readiness tasks that separate you from being able to

move from costly and slow paper intensive submissions to the speed and

efficiency 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 submission

option to use, the FDA ESG Web Interface (WebTrader) or the AS2 Gateway-to-

Gateway. This determination is based on types of submissions to be

transmitted, infrastructure capabilities and business considerations. The

WebTrader is the low-cost option and has fewer set-up requirements than the


Gateway- to-Gateway option. During the 2009 implementation, many

companies found that establishing their accounts was more time-consuming

than they had envisaged. Time to setup accounts are now reported as four to

eight 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


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 Health

Level Seven (HL7) ICSR standard for the reports. Two options for preparing

eMDRs 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.


I have edited a 2-hour web-training course that was presented by FDA this June

2011 as part of this presentation, which I will show to you now. This small

excerpt reiterates the commitment of FDA to mandatory electronic submissions

of Medical Device Reports and speaks in more detail about some of the items

you, the China medical device manufacturer, must consider as you plan and

establish your electronic system to communicate with FDA.

[play movie clip]

Electronic Submissions Speech

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