By Thomas K. McInerny, Henry M. Adam, Deborah E. Campbell, American Academy of Pediatrics
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A reviewing court may overturn or reverse an agency action if it finds any of the following to be true: s 4HE AGENCY EXCEEDED ITS STATUTORY AUTHORITY Background and Regulatory Environment 25 s 4HE AGENCY ACTED IN AN UNREASONABLE OR ARBITRARY MANNER s 4HE AGENCY FAILED TO FOLLOW APPROPRIATE ADMINISTRATIVE PROCEDURES as required by the Administrative Procedures Act, the agency’s own procedural requirements, or the established principles of administrative law. s 4HE LAW OR REGULATION THAT WAS BEING ENFORCED WAS UNCONSTITUTIONAL PART 8.
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Accepting and Reviewing Public Comments The second step in the regulatory process is the acceptance and review of comments received by FDA. In this context, any private individual, medical device manufacturer, institution, association, or public interest organization may submit comments on the proposed regulation. Comments may oppose the entire concept of the proposal, may oppose specific sections of 22 Chapter One the proposed regulation, may support any or all of the provisions, or may suggest additions, deletions, or amendments to the proposal.