Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2022

Month: January

Request Number: A-2021-001324

Request Summary: Why sterility indicators aren't considered medical devices. Policy documents, records of decision, legal opinions or other supporting documents that supports this stance. How many problems have been reported for these devices, how many recalls have been issued and what the proposed regulatory method is for handling problems with these products.Time frame: 2000-01-01 to 2021-11-03.

Disposition: Disclosed in part

Number of pages: 47

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