FDA Issues New Guidance for the Use of Standards in 510(k)s

ON MARCH 12, the Food and Drug Administration (FDA) released a new guidance to assist manufacturers in using standards in 510(k) submissions. Since the passage of the FDA Modernization Act (FDAMA), manufacturers have expressed their concerns that the law appears to require that a manufacturer acquire all of the data relevant to compliance with a standard before submitting a Declaration of Conformance to FDA. While the new guidance confirms that this is the case for submissions under section 514 (c) of FDAMA. It also notes that FDAMA strengthens FDA's justification for accepting a manufacturer's assurance that a marketed product will conform to a standard, without having the data in hand at the time the submission is made. Download a copy of the guidance. (pdf)

The new guidance provides three separate avenues for manufacturers' use of standards to reduce the quantity of data submitted in a 510(k).

1. Declaration of Conformance per FDAMA - In this case, the manufacturer submits a Declaration of conformance with a standard recognized by FDA. The manufacturer must have already developed the data pertinent to the declaration, and the data must be available for inspection during QS inspections. The Agency is obligated to accept the declaration.

2. Promise to Comply with an FDA Recognized Standard - The manufacturer assures the Agency that the product in question will comply with a specific standard when it is marketed. In this case, the data supporting compliance will not yet be developed at the time of the submission, but must be available for inspection when the product is placed on the market. The Agency is not under a legal obligation in this case, but will normally treat it the same as for a Declaration of Conformance.

3. Promise to Comply with a Standard Not Recognized - This is similar to case 2. However, the reviewers will in most cases familiarize themselves with the requirements and appropriateness of the standard before ruling on the submission. When they find a standard acceptable for the submission, they will be expected to enter into the Agency's recognition process.

In the above situations, reviewers are not expected to request companies to submit data related to conformance with a standard without consulting with their immediate supervisors and their Division Directors.

FDA plans to include all three paths in the definition of "abbreviated 510(k)" at the next revision of the 510(k) Paradigm.