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16 C.F.R. Part 803 AppendixTRANSACTION NUMBER ASSIGNEDNOTIFICATION AND REPORT FORM FOR CERTAIN MERGERS AND ACQUISITIONS INFORMATION AMOUNT PAID(For Payer Only)in cases where your filing fee would
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Who needs part 803 appendix?
01
Medical device manufacturers
02
Importers or exporters of medical devices
03
Distributors or retailers of medical devices
04
Healthcare facilities or institutions
05
Healthcare professionals
06
Regulatory authorities
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What is part 803 appendix?
Part 803 appendix is a form used to report information to the appropriate regulatory authorities.
Who is required to file part 803 appendix?
Manufacturers and importers of certain medical devices are required to file part 803 appendix.
How to fill out part 803 appendix?
Part 803 appendix can be filled out online or submitted via mail with the required information.
What is the purpose of part 803 appendix?
The purpose of part 803 appendix is to track and monitor medical device safety and performance.
What information must be reported on part 803 appendix?
Information such as adverse events, malfunctions, and defects must be reported on part 803 appendix.
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