FDA Addresses Industry Feedback On Routine Inspections By Formalizing Processes And Standards In A Draft Guidance

Author:Ms Patricia B. Shrader, Jodi Scott, Michael S. Heyl, Edward C. Wilson, Jr. and Dennis C. Gucciardo
Profession:Hogan Lovells

On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection Processes and Standards." This draft guidance was issued to meet requirements set out in the FDA Reauthorization Act of 2017 (P.L. 115-52) (FDARA), which stated that FDA would implement uniform processes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 While much of the information in this draft guidance reflects existing FDA policy for device inspections, the intent of the guidance is to clarify and standardize inspection processes to the extent possible.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The draft guidance calls for FDA to notify the owner, operator, or agent in charge of a facility by telephone prior to a surveillance or preapproval inspection.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 The draft guidance also indicates that during the preannouncement, investigators may tell the firm the hours during which the inspection will take place as well as the expected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The draft guidance states that the standard time frame for inspection ranges from three to six continuous business days, depending on the type of inspection being conducted.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...

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