Posted 06 November 2014
By Alexander Gaffney, RAC
The US government's Office of the Federal Register (OFR) has finalized a rule calling on the federal agencies, including the US Food and Drug Administration (FDA), to offer more information about third-party standards they require companies to comply with.
If you're in the regulated healthcare products space—and in particular are involved with medical devices—you probably already know a thing or two about standards. There are of course standards FDA creates itself, often for low risk (Class I) and moderate risk (Class II) medical devices.
However, there are also standards created and maintained by outside organizations such as the International Standards Organization (ISO) and the American National Standards Institute (ANSI).
These standards, of which there are hundreds, cover everything from general device performance characteristics to specific standards applicable to just one device or a subset of devices (e.g. urology or cardiovascular devices). The standards are often highly technical, time-consuming to produce and, above all else, expensive to create. Rather than create its own standards or duplicate the efforts of other groups, FDA often chooses to adopt the standards of outside groups wholesale or with minor alterations.
But with the adoption and use of outside standards—also known as Incorporation by Reference—comes a notable problem: The standards are generally not able to be viewed by the public for free.
Because the standards are developed in whole by outside organizations, those groups copyright the standards and charge for access to them in order to recoup their costs.
For companies, that's rarely a major problem, as many see the standards as another cost of doing business with regulators. But for members of the public—and in particular government watchdogs, clinicians and academics who keep track of device safety—the expense to access third-party standards can be prohibitive.
The public, however, does have one recourse: The Office of the Federal Register requires all documents incorporated by reference to be made "reasonably available" to everyone.
What that means in practical terms hasn't been well defined, however, despite attempts to clarify its meaning through the citizen petition process. Should, as the petitioners argue, "reasonably available" mean "free" and "available online?" Or should federal regulators develop an alternate approach?
In a response to one of those petitions, in 2013 OFR released a Federal Register notice proposing that standards should be available to the public more easily, but that access should not necessarily be free or digitally available. The problem, OFR said, is that it lacks the statutory authority to require standards to be free or available online.
"The OFR has no authority to create agencies, change how standards development organizations (SDOs) operate, or amend existing statutes," it explained. "Regulated entities … and their trade associations should work directly with the agencies issuing regulations to ensure that all regulated entities and their representatives have access to the content of materials Incorporated by Reference."
However, OFR did agree that agencies should make outside standards more available to the public. Under its proposed rule, it said agencies would need to "add more information regarding materials incorporated by reference to the preambles of their rulemaking documents."
"We propose that they set out in the preambles a discussion of the actions they took to ensure the materials are reasonably available to interested parties or summarize the contents of the materials they wish to incorporate by reference," OFR wrote. Alternately, agencies may still attempt to make the materials "reasonably available" to the public.
Under the new language, finalized by OFR in a final rule announcement on 6 November 2014, an agency incorporating a standard by reference must:
- Discuss, in the preamble of the proposed rule, the ways that the materials it proposes to incorporate by reference are reasonably available to interested parties or how it worked to make those materials reasonably available to interested parties
- Summarize, in the preamble of the proposed rule, the material it proposes to incorporate by reference.
In addition, agencies must "Request formal approval by:"
- Send a letter that contains a written request for approval at least 20 working days before the agency intends to submit the final rule document for publication
- Discuss, in the preamble of the final rule, the ways that the materials it incorporates by reference are reasonably available to interested parties and how interested parties can obtain the materials;
- Summarize, in the preamble of the final rule, the material it incorporates by reference
- Send a copy of the final rule document that uses the proper language of incorporation with the written request
- Ensure that a copy of the publication is on file at the Office of the Federal Register.
The final regulation comes into effect in 60 days after its formal publication in the Federal Register.
OFR: Incorporation by Reference