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Stakeholders with questions on PMSR requirements for combination products are encouraged to review these resources and, if you have questions, contact the Office of Combination Products at combination fda. Postmarketing Safety Reporting for Combination Products.
FDA is delaying enforcement of these provisions to ensure that Combination Product Applicants have sufficient time to update reporting and recordkeeping systems and procedures, including their information technology systems, to comply with the combination product PMSR requirements. For additional information, see the associated Technical Specifications:.
FDA welcomes comments from combination product reporters. Comments may be submitted to the Office of Combination Products, combination fda.
The content included here is intended to assist Combination Product Applicants in presenting certain combination product information in the data fields of the drug and device reporting systems FAERS and eMDR, respectively 1.
Reporters should refer to current technical specifications and other documents for detailed instructions for how to complete and submit electronic ICSRs.
Example Scenarios. Scenarios to illustrate how to report combination product information identified in section V.
Identifies the data fields for the combination product information described in Section V. Device Product Codes procodes.