CDRH Finalizes Policy Intended to Help Device Industry Reduce Regulatory Uncertainty

| 01 April 2014 |  By 

A new standard operating procedure (SOP) unveiled last week by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) establishes how the agency plans to implement and update certain types of guidance documents.


Guidance documents are commonly used by FDA to indicate its specific interpretation of otherwise vague statutory requirements. While they almost never establish legally enforceable standards (though they can, such as if Congress directs FDA to pass a guidance containing certain requirements), they are nevertheless enormously influential.

While FDA's various centers release many guidance documents each year, there are two distinct types.

Under 21 CFR 10.115-FDA's Good Guidance Practices (GGP) regulation-FDA is required to use several types of guidance documents:

  • Level 1 Guidances: Set forth initial interpretations of statutory or regulatory requirements; Set forth changes in interpretation or policy that are of more than a minor nature; Include complex scientific issues; or Cover highly controversial issues.
  • Level 2 Guidances: Set forth existing practices or minor changes in interpretation or policy. Level 2 guidance documents include all guidance documents that are not classified as Level 1.

These guidance documents may also be issued in accordance with various time frames. In general, draft guidance documents are subject to a lengthy comment period, while final draft guidance documents may also be subject to a small period of delay (though not always).

There is, however, a third type of rarely used guidance document known as the "immediately-in-effect" guidance, reserved for Level 1 guidance documents. These guidances are reserved for when FDA needs to make an immediate change to protect public health. To borrow a phrase, they allow FDA to "shoot first and ask questions later," with the guidance remaining in effect while FDA then asks industry for ways to tweak it.

Why Guidance Types Matter

For medical device manufacturers, guidance documents can pose unique issues.

For example, a medical device manufacturer might have conducted extensive clinical trials on a high-risk (Class III) medical device according to the current guidance documents, and used data obtained from those trials to support a premarket application (PMA) to the agency. But after the submission of that application, FDA might decide that, based on a public health problem, it can no longer accept the type of data generated by the manufacturer.

Such changes introduce an enormous degree of regulatory uncertainty into the approval process, and can be ruinous for device manufacturers-especially small ones with small monetary reserves or market caps.

However, those changes are often necessary to protect consumers from dangerous devices or testing practices known to be insufficient. So how, then, can FDA protect consumers while still providing a degree of regulatory certainty for companies who faithfully follow its regulations and guidance documents?

Helping the Device Industry

The answer, it seems, is with immediately-in-effect (IIE) Level 1 guidance documents. In a 26 March 2014 Federal Register notice, FDA indicated that it has released a new SOP on the use of IIE guidance documents related to premarket data issues.

The new SOP will allow CDRH to "clarify and more quickly inform stakeholders when CDRH has changed its expectations relating to, or otherwise has new scientific information that could affect data submitted as part of an Investigation Device Exemption (IDE) or premarket submission," FDA wrote in its Register notice.

The changes, which will see CDRH speeding up its guidance documents, is being done in response to an August 2010 report in which the agency was advised to communicate meaningful changes to industry in a "meaningful and timely manner" using "more rapid tools for broad communication on regulatory matters."

At present, FDA said its practices are often implemented on a case-by-case basis, and a final guidance document may take more than a year to implement based on resource constraints within the agency.

Under the new policy, FDA will develop Level 1, IIE guidances if three criteria are met:

  1. New scientific information has been identified that raises new risk/benefit information.
  2. FDA's regulatory expectations change as a result of (1).
  3. Public comment is not feasible based on time constraints.

If these criteria are met, CDRH staff will meet with the Center Science Council (CSC) to brief the council and to explain why changes are both necessary and proper, and why a IIE guidance document is the best course of action.

FDA explained that these guidance documents will likely only be 1-3 pages and length-far shorter than the average guidance document, which tends to range between 8-12 pages in length, and can be much longer.

The change should, if FDA's theory is correct, permit companies to adjust their regulatory course earlier in the process, saving them time and money.

CDRH SOP: Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues  (FR)


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