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Changing Your Manufacturing Site Location? Read This FDA Proposal

An FDA draft guidance addresses submission and inspection requirements when a company moves where device manufacturing activities take place, either within a single facility or to a completely new location, or to a contract manufacturer. It’s the latest effort by FDA to clarify what has historically been a nebulous area for manufacturers: what steps to take when making a modification to an approved device.

A 180-day PMA supplement is in the cards for a company that wants to move manufacturing activities for a device to a location not previously approved for the same production processes. But if the new location is already approved for the same type of steps, the firm can likely move ahead more quickly with the change under FDA's 30-day notice policy, according to a new draft guidance.

The agency posted the draft, "Manufacturing Site Change Supplements: Content and Submission," on Oct. 20. It is FDA's latest effort...

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