ComplianceOnline

Be Ready for eMDR Going Live August 14, 2015

Instructor: Rita Hoffman
Product ID: 703972
  • Duration: 110 Min

recorded version

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Read Frequently Asked Questions

This training program will discuss the basics of the Medical Device Reporting (MDR) regulation and review the process for preparing and submitting Electronic Medical Device Reports (eMDRs).

Why Should You Attend:

Being ready for the live eMDR is critical for your company. Mistakes in timing for submission, sending incorrect information and not being prepared to respond to an FDA inspector can cause a company needless time and money to correct issues.

Electronic reporting is also available to user facilities; however, the eMDR Final Rule permits user facilities to continue to submit only written reports to FDA. The requirements of this final rule will take effect on August 14, 2015.

This webinar will:

  • Provide an overview and answer questions related to FDA’s final rule requiring device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the FDA’s electronic format that FDA can process, review, and archive (hereinafter referred to as the eMDR Final Rule).
  • Provide general information regarding how to prepare and send an electronic postmarket medical device report to the Center for Devices and Radiological Health (CDRH) in FDA.
  • Help identify where you can find more detailed information on the preparation and transmission of the reports.
  • Review background on regulations pertaining to MDRs and who should or should not file via eMDR.

Areas Covered in the Webinar:

  • Basics of the Medical Device Reporting (MDR) Regulation
  • Medical Device Reporting: Electronic Submission Requirements Final Rule
  • Actions that Firms Have to Take Prior to Live Date
  • Review the Basic Process for Preparing and Submitting Electronic Medical Device Reports (eMDRs)
  • Best Practices for Your Firm Using eMDR
  • Timing for Submission to eMDRs
  • Which System Works Best for Your Firm?
  • Readiness for FDA Inspector

Who Will Benefit:

  • Complaint handling units
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Regulatory/legislative affairs professionals
  • IT department supporting complaint handling
  • Regulatory affairs reporting units

Instructor Profile:

Rita Hoffman is the principal consultant for Regs & Recall Strategies, LLC, a consulting firm providing regulatory insight focusing on industry assistance on FDA compliance issues.

Prior to working as a consultant, Ms. Hoffman spent more than 36 years with the FDA. She retired in 2011 after holding the position of recall branch chief for the Center for Devices and Radiological Health (CDRH). She was responsible for oversight and review of all medical devices recalls with extensive knowledge of the legal authority of 21 CFR Parts 7 & 806, 803 and 820 of the Act. During Ms. Hoffman’s tenure with FDA, she served in several critical headquarter positions including: compliance officer, ombudsman, jurisdictional review officer, small business liaison, and policy analyst.

Ms. Hoffman has a diversified knowledge encompassing FDA scientific, investigational and regulatory policy areas due to her in-depth understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. Throughout her FDA career, she has provided guidance and clarified FDA requirements, to industry, foreign governments, public entities and FDA field personnel involving recalls, labeling issues, dietary supplements, pharmaceuticals, OTC drug products and combination products.

Ms. Hoffman continues to collaborate with industry as an expert advisor and remediates on regulatory subject matters including drug/device for recalls, GMP and quality systems inspections/regulations, field safety alerts for drug products, MDR and complaint handling, and other matters. She has been hosting trainings with ComplianceOnline for over 4 years on MDRs, compliant handling and recalls.

Ms. Hoffman is regulatory certified by the Regulatory Professionals Society (RAPS) and holds a BS from the University of Maryland in addition to the many awards she has received from both government and industry.

Topic Background:

21 CFR PART 803 Electronic Reporting for Medical Device Adverse Event reporting (eMDR) is a requirement as of August 14th, 2015. The Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule effective August 1, 2015, requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting will improve the agency's process for collecting and analyzing postmarket medical device adverse event information. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA. This final rule also identifies changes to the content of required MDRs to reflect reprocessor information collected on the Form FDA 3500A as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

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