FDA moves to formalize processes and standards via draft guidance on routine inspections

On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection Processes and Standards."

This draft guidance was issued to meet requirements set out in the FDA Reauthorization Act of 2017 (P.L. 115-52) (FDARA) which stated that FDA would implement uniform processes and standards applicable to inspections of foreign and domestic medical device facilities. It does not apply to for-cause inspections. While much of the information in this draft guidance reflects existing FDA policy for device inspections, the intent of the guidance is to clarify and standardize inspection processes to the extent possible.

Advance notification of inspection

The draft guidance calls for FDA to notify the owner, operator, or agent in charge of a facility by telephone prior to a surveillance or preapproval inspection. This advance notification for domestic inspections is to occur no less than five calendar days in advance. The notification should include the type of inspection and whether the inspection will be comprehensive, abbreviated, or preapproval. The draft guidance also indicates that during the pre-announcement, investigators may tell the firm the hours during which the inspection will take place as well as the expected length of inspection. Finally, the agency should provide advance notice of some of the records that may be requested during the inspection.

FDA also notes that notification for a foreign inspection often is longer due to the need for investigators (and company representatives) to make travel plans and secure visas as needed.

Standard inspection time frame

The draft guidance states that the standard time frame for inspection ranges from three to six continuous business days, depending on the type of inspection being conducted. The length of the inspection may be extended beyond that which was initially planned based on numerous factors, including the complexity of the firm's operations, availability of knowledgeable firm staff, the nature of any observed deficiencies, or if FDA follows up on postmarket safety information. The typical inspection should be conducted on consecutive business days.

FDA should verbally communicate to the firm any extension of the inspection beyond the original time frame provided.

Communication during inspections

FDA's updated processes, including the Inspection Operations Manual, guidance documents, manuals, programs, and internal standard operating procedures, also call for regular verbal communications during the inspection between the FDA investigator and the firm. All observations should be discussed with firm management when they occur or on a daily basis, when time and circumstances permit. This is intended to minimize errors and misunderstandings. Either FDA or the firm may record these communications, as long as the other party has advance notice and consents. We suggest that careful consideration be given to this decision to create a recording.

Why is this guidance important?

In the run-up to FDARA, numerous companies complained that previously stated FDA policies for inspections of device facilities, including advance notification of inspections, communication of observations, and predictable inspection lengths, were being ignored by FDA. Companies also noted that advance notification permitted a company to get prepared for an FDA investigator, thereby making the inspection more efficient, while an inspection conducted over an extended period of time and on nonconsecutive days was extremely disruptive to company operations. This guidance, when finalized, may provide facilities being inspected with a resource that can help the management of and expectations for announced inspections.

It is important to note that, with respect to most of the provisions of the inspectional policies, an FDA investigator has considerable latitude to deviate depending on the particulars of the inspection. Accordingly, the decision whether a company chooses to discuss this guidance with an investigator during the course of an inspection often benefits from a discussion of the inspection to date with an objective outsider. Our Medical Device team has assisted numerous companies in understanding how best to utilize FDA policies in the course of an inspection.

We are always happy to assist a company with this decision.


Authored by Michael S. Heyl, Jodi K. Scott, Ted Wilson., Patricia Shrader and Dennis Gucciardo


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