Changes in FDA's Device Corrections and Removals Reporting

Duration: 60 Minutes
FDA has proposed a dramatic change to what should be reported under the Corrections and Removals regulation for devices. The change significantly broadens the scope of what is reportable to FDA.
Corrections and Removals Reporting
Instructor: Casper E Uldriks
Product ID: 500128
Accordingly, the following questions require your attention:
  • What are the current recall reporting requirements?
  • How has FDA broadened recall reporting requirements?
  • How would the change affect your health risk assessment criteria for the Medical Device Reporting regulation?
  • What are the business consequences for reporting proprietary information?
  • How would the change affect a firm's FDA risk assessment procedure and product liability considerations?
FDA's original implementation of the Corrections and Removals under the Safe Medical Devices Act of 1990 required firms to report a Class I or Class II recall to FDA. The FDA health risk evaluation criteria were the same for Medical Device Reporting. Firms were not required to report Class III recalls or product enhancements under either regulation. Likewise, firms were not required to report product enhancements or design changes. This meant that design enhancements were not per se subject to reporting. Design enhancements were managed under the Quality System regulation. How firms will manage the change in FDA's reporting requirements is unclear but the consequences are significant.

Why Should you Attend:
FDA has proposed that firms submit information to the agency that was not required before. The scope of reporting now covers changes that reflect Class III recall criteria. Procedures for how you manage a Class III recall will require revision. Also, FDA is more likely to inspect your Class III recall procedures and your Class III determinations. FDA's proposed change also includes design enhancements that are not related to recalls. You need to determine how these changes affect your current procedures for making design enhancements that are not related to recalls or those that are related to a Class III recall risk criteria.

Objectives of the Presentation:
You will understand the difference between existing device recall reporting requirements and those under FDA'S proposed changes. Understanding the proposed changes will give you a practical guide as to what you may need to revise in your current health risk procedures and design change assessment. You will be able to provide an initial explanation to your firm about the impact of FDA's proposed changes on product liability considerations.

Who can Benefit:
Firms that meet the following categories:
  • Conduct recalls
  • Do not report Class III recalls to FDA
  • Do not have a Class III recall strategy or procedure
  • Make product enhancements, such as design changes
  • Use product liability considerations in making risk assessments and product enhancements
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Instructor Profile:
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
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