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Nov 23, 2015 ... subpart E, regarding premarket notification ... Service will revise MM sections 213.5, 292.45, 293.45, the ... Manual (MM) ...... (80 FR 40768), September 11, 2015 (80. FR 54760),

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What is subpart e regarding premarket?

Subpart e regarding premarket refers to the section of regulations that outlines the requirements for premarket notification of new medical devices.

Who is required to file subpart e regarding premarket?

Manufacturers or distributors of new medical devices are required to file subpart e regarding premarket.

How to fill out subpart e regarding premarket?

Subpart e regarding premarket must be filled out by providing the necessary information about the new medical device being brought to market.

What is the purpose of subpart e regarding premarket?

The purpose of subpart e regarding premarket is to ensure the safety and effectiveness of new medical devices before they are marketed to the public.

What information must be reported on subpart e regarding premarket?

Information such as the intended use of the device, its design, testing results, and labeling must be reported on subpart e regarding premarket.

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