Regulations are a set of legal rules that are established by a regulatory authority such as the FDA. They are required to be followed and are enforceable by legal consequences such as fines or imprisonment. The process of making a regulation can be a lengthy but important process. Federal agency priorities, industry trends, public safety, or new technology are potential reasons for creating a new rule, which can later become a federal regulation. The process of “rulemaking” is simply described:

Gathering Information

Information on issues that may be of concern to individuals of interest is gathered. An individual may suggest a “Petition for Rulemaking” to a federal agency, which can then be published in the Federal Register. The Federal Register is a public newspaper published daily, containing proposed rules, notices, executive orders and other presidential documents that allow the general public to comment on such issues. Before public commenting, only changes and actions that have been deemed significant are sent to the Office of
Information
&
Regulatory
Affairs (OIRA), which are used to assist the President in analyzing important policy issues.

Proposed Rule

The proposed rule, or Notice of Proposed Rulemaking (NPRM), is then submitted to the Federal Register by one of the federal agencies so that it may be open to public comments. That agency must also take into account any scientific data that may pertain to the rule, expert opinions and facts that have accumulated from the general public or other agencies that may be affected. Taking these concerns or ideas into consideration, the proposed rule is either withdrawn or further revised and then submitted to become a final rule.

Final Rule

Next, the agency submits the draft rule to the OIRA and the President for review and approval to be published in the Federal Register as a final rule. New final rules are then integrated in the Code of Federal Regulations (CFR). The final rule shall contain a summary, effective date, and supplementary information. Included in the supplementary information portion are statements on how the agency relies on facts and data, what problems the rule addresses, and any responses to major criticism received from the general public during the comment period.

Federal Regulations

After the proper structure has been implemented, the final rule is published in the Federal Register as a regulation, and lastly added to the official record of all regulations, the CFR. The CFR is an organized, convenient reference for those who may need to know federal regulations.

Revising a Regulation

The 50 titles of the CFR are published with any revisions at least once a year, with approximately one fourth of the titles being updated each quarter. The List of CFR Sections Affected (LSA) is published by the Office of Federal Register, and contains proposed, new, and amended regulations that have been published in the Federal Register since the most recent revision date.

Clinical Research Regulations

Title 21 CFR 812 is especially important to Clinical Research Associates, as it deals with investigational device exemptions and regulatory requirements for sponsors and investigators running these studies. This regulation was published in the Federal Register as a proposed rule in July of 1998 and became a final rule in November later that year. Different sections have been updated at various times since 1998. The most recent revision of this regulation was made in October of 2016 with updates to the Definitions section. Other important clinical research regulations include 21 CFR Parts 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards), and 11 (Electronic Records and Signatures).  

Are you familiar with the pertinent regulations to your clinical trial? Are you familiar with the history of clinical research and reasons for establishing many of the clinical research regulations? Leave us a comment, or check out IMARC’s resources for more information about important clinical research regulations.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.