Device Firms Want Two Years To Comply With Electronic MDR Rule

Full article reprinted from "The Gray Sheet" - November 30, 2009

Covidien, AdvaMed and the Medical Imaging and Technology Alliance are asking FDA to give device manufacturers two years to comply with an upcoming rule requiring adverse event reports to be submitted to the agency electronically. Read more...

Device Firms Want Two Years To Comply With Electronic MDR Rule

Full article reprinted from "The Gray Sheet" - November 30, 2009 

Covidien, AdvaMed and the Medical Imaging and Technology Alliance are asking FDA to give device manufacturers two years to comply with an upcoming rule requiring adverse event reports to be submitted to the agency electronically.

FDA's Aug. 21, 2009, proposed rule would give manufacturers just one year to comply.

For companies that file large numbers of reports, in particular, the activities involved in switching from the current paper-based system to the new electronic one "are considerable," Covidien says in Nov. 18 comments to FDA.

"Customized code of internal complaint tracking systems will need to be significantly redesigned, developed and validated to send eMDRs, provide attachments and track and retain FDA acknowledgements," Covidien writes.

AdvaMed adds that giving companies two years from the time the final rule is published would better allow for budgetary and design planning "as well as the financial cycles required to secure funding for an electronic solution of this magnitude."

The proposed electronic Medical Device Reporting (MDR) rule is intended to help FDA more rapidly identify and respond to device malfunctions or problems that could lead to death or serious injury.

Currently, FDA must manually input the information from paper submissions into the agency's MAUDE adverse event database, a process that can take anywhere from three days to more than six months, according to the agency (The Gray Sheet' Aug. 24, 2009).

The planned e-reporting system is strongly supported by the Patient and Consumer Coalition, a group that includes the Consumers Union, the National Research Center for Women & Families, the Government Accountability Project and seven other groups.

"If the FDA identifies problems and acts upon them sooner, we anticipate that fewer patients and consumers will be harmed by medical device problems," the coalition says in Nov. 19 comments to the agency.

Abbott, Covidien, AdvaMed and MITA also support FDA's move to electronic MDR submissions, saying it will produce a more efficient process. But they request various small changes to the system as outlined in the proposed rule.

In addition to extending the implementation period from one to two years, the industry groups would like FDA to simplify its system for acknowledging receipt of an electronic report. The proposed rule would have FDA send the company three separate acknowledgements at different points in the process, and would require the company to retain all three.

AdvaMed recommends that FDA adopt the date and time in the first acknowledgement as evidence that the report was received by FDA, and that all three acknowledgments be combined into a single comprehensive acknowledgement.

Commenters Ask FDA To Plan Ahead For IT Failures

The industry commenters also urge FDA to consider how to deal with unexpected IT system outages. AdvaMed suggests a grace period to statutory filing deadlines for mandatory MDRs when the agency's IT infrastructure is unable to receive and acknowledge submissions.

Abbott, meanwhile, suggests a "back-up" reporting system, such as submission of a paper form via facsimile, when FDA's IT system is down. The Medical Imaging and Technology Alliance, representing medical imaging equipment manufacturers, suggests that FDA accept paper copies of the currently used Form 3500A, followed by an electronic report when the system issue is resolved.

AdvaMed also recommends that FDA formulate a "firm and clear" policy for managing and communicating software changes and scheduled maintenance of its electronic data system. The trade association argues that industry users of complex gateway-to-gateway, large-volume systems may need up to 12 months to adjust to certain types of FDA software changes.

Ideally, FDA should adhere to a predictable, biannual schedule for software releases and should provide guidance regarding due diligence and validation testing required of industry with each release, AdvaMed says in its Nov. 19 comments.

- Mary Houghton

FREE i-Phone Device Report*
FREE 30-Day Trial of "The Gray Sheet"
No obligation. No credit card needed. Click here to sign up

(*SPECIAL REPORT: When is an iPhone a Medical Device? - $129 Value - FREE)

Hot Off the Presses: Medical Device Market 2009: Interventional Cardiology - This 86-page Special Report from IN VIVO identifies the most important trends in cardiology devices in recent years, teases out the critical decisions that drove those developments, and takes you behind the scenes and into the minds of the architects of these new technologies and business strategies. Find out more...

To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Sean Smith at 240-221-4535 or se.smith@elsevier.com.