Which clearance is actually involved
The phrase covers several unrelated processes. Mergers and acquisitions above certain size thresholds require a premerger filing with the Federal Trade Commission and the Justice Department, followed by a waiting period before closing. Medical devices shown to be substantially equivalent to one already on the market are usually cleared by the FDA through a premarket notification, which is different from the approval required for higher-risk devices. Investments by foreign persons in some American businesses may need review by CFIUS, sometimes on a mandatory basis. Industry regulators in fields like banking, energy, or telecommunications can add approvals of their own.
Preparing a submission that holds up
Each process asks for information in its own format, but the common thread is that inconsistencies cause delay. For a merger filing, internal documents discussing competition and market share are usually part of what is submitted, so how the deal was described internally matters. For a device, testing data and the comparison to a predicate device carry the submission. For a foreign investment review, ownership chains and any ties between the investor and a foreign government are central. Gather these early, and make sure the people preparing different filings are telling the same story. Documents held by foreign affiliates, and any translations they need, often take longer to collect than planned.
Building clearance into the timetable
Deal and launch timelines often assume clearance will arrive on the earliest possible date. A request for additional information from a regulator can extend the review substantially, so transaction documents usually address what happens if clearance is delayed or conditioned. We look at which filings are needed, whether any must be completed before closing, and how the risk of delay is allocated between the parties. In some matters a conversation with the agency before filing is worthwhile. Closing before a required waiting period ends, or combining operations too early, can create liability of its own, so the interim period needs rules too.
