Medical Device Markets

Exploring 30 Years of Preambles

Understanding a final rule requires digging into its preamble—and we’ve had plenty in the last 30 years. Here is one example.

Nancy J. Stark, Julia Baresch

June 1, 2009

5 Min Read

Regulatory Reflections

A preamble is an introduction to a law or regulation that explains the intention of the document. Although preambles themselves do not have the force of law, they have tremendous value in the application of a law or regulation to a particular situation. The preamble is published only once, and if you want to read one and don't have a copy, you'll find yourself visiting the nearest archival library to obtain a barely readable copy on microfiche.

Consider the development of a new regulation. The first version of the regulation is published by FDA as a proposed rule, and comments are invited from the public. FDA's guiding purpose must be the protection of public safety and the regulation itself must be authorized by a governing act of Congress.
Anyone may comment: you as an individual, you on behalf of your company, trade associations, and even foreign entities may comment on the regulation. Comments vary and can include proposals to include the following:
•Remove requirements.•Weaken or alter requirements.•Support requirements.•Add requirements.
After comments are received and collated, FDA accepts some comments entirely, accepts some comments partially, and outright rejects other comments. The agency prepares a rationale for its decision regarding each group of comments. Finally, the final rule is published in the Federal Register, preceded by the preamble consisting of the comments and FDA's decisions and rationales.
As an example, we looked back at the publication of 21 CFR Part 812 from its inception to its publication as a final rule. It was in the 1960s that Congress amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) with the Kefauver-Harris Amendments. The purpose was to authorize and require FDA to promulgate regulations of medical devices undergoing clinical investigation. The first proposed regulations were finally published in August 1976, more than a decade later. Comments were received, and a revised proposed rule, the reproposed Part 812, was published in May 1978. More comments were received, and a final Part 812 published in January 1980 became effective in July 1980.
Although Part 812 has been amended about 25 times since 1980—and each amendment has gone through the same proposal, comment, and final rule cycle—the bulk of the regulation remains unchanged. And that brings us to the value of looking at the nearly 28-page preamble to Part 812, which addresses many nuances in the final rule.
The 1980 preamble is now nearly 30 years old—older than some of the reviewers who will review a manufacturer's 510(k)s and PMAs. And the Federal Register is available only back to 1994 on the Internet (www.gpoaccess.gov/fr), which means that reviewers do not have easy access to the document. Regulatory professionals may know the intent of the regulations better than the reviewers or inspectors, giving those professionals internal credibility in regulatory decision making and an advantage in dealings with FDA.
An Example

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Question 42 in the preamble to the final CFR Part 812 highlights the value of digging into the preamble to understand the rule.

Occasionally, companies ask us if they can maintain an in-house institutional review board (IRB) to review clinical trial protocols for studying devices on healthy, employee volunteers. At first the idea of a company IRB seems strange. But question 42 in the preamble to the final Part 812 (CFR vol. 45, no. 13, p. 3740) states:¹

42. One comment argued that ‘institution' should not include a manufacturer because a manufacturer should not be required to create an in-house IRB.

FDA disagrees. A manufacturer must be subject to the requirements of institutional review if an investigation is carried out on the manufacturer's premises, for example, using employees as subjects of the investigation. Employees are entitled to the same protections, including IRB review, as other subjects.

The preamble makes it clear that manufacturers may carry out clinical investigations of devices on healthy, volunteer employees; that manufacturers may create and maintain their own IRBs; and that the employee volunteers are entitled to the same protections as other subjects. Entitlement to the same protection is interpreted to mean that in-house studies on healthy, employee volunteers must be compliant with Part 812, just like any other study. Unfortunately, this important nuance is lost to anyone who doesn't read through the preamble.
The regulations are often vague because they have to work for everything from toothbrushes to jaw implants. And innovative companies are always doing something that no one would ever think of. The preamble gives medical device manufacturers the backstory to the regulation, so they can “get into FDA's head” and discern what the writers of the rule were thinking.
Nancy Stark is president of Clinical Device Group Inc. (Chicago). Julia Baresch is research assistant at the company.
Conclusion
In order to really understand the reason and intent of a regulation, device manufacturers must take time to dig deep into its preamble. Sometimes this requires looking further than the Internet. It is important to reiterate, however, that although preambles do not state law and therefore are not judicially enforceable, they are used to determine legislative intent when interpreting statutes. CFR Part 812 is a perfect example of how a question and an answer in the Federal Register about its application relies squarely upon the wording of the preamble.
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