Have an Idea for a Medical Device Guidance? CDRH Says it Wants to Know

Posted 07 May 2014 | By Alexander Gaffney, RAC 

Regulatory compliance is sometimes less of a science and more of an art of interpretation-an art subject to frequent changes and reinterpretations as science advances and new regulatory decisions are made and precedence established.

For example, what the US Food and Drug Administration (FDA) wants in a drug application (with respect to clinical endpoints, enrollment criteria, secondary endpoints, and trial design) can change drastically from year to year, especially in response to drug safety scandals or political pressure.

In general, regulators try to provide clear expectations for industry by establishing so-called "guidance documents," which explain in plain terms what FDA wants out of a particular trial, or how it expects to enforce a specific provision, or how it interprets a specific provision that goes undefined in a statute.

But sometimes what FDA has provided guidance on differs from what industry would like it to provide guidance on.

So every so often, FDA sends out a notice to the regulatory community asking, in essence, one question: What should we be focusing on that we currently aren't, and which regulatory guidance documents should we prioritize?

On 6 May 2014, FDA's Center for Devices and Radiological Health (CDRH) sent out just such a notice to industry, indicating that it is soliciting feedback regarding the development of future guidance documents and the prioritization of those guidance documents.

The agency will be soliciting electronic comments on its guidance development agenda, and will also hold a meeting on 5 June 2014 at the agency's White Oak campus in Silver Spring, MD. Anyone interested in attending the meeting can register here, or register for a webcast of the meeting here.

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