FDA addresses industry feedback on routine inspections by formalizing processes and standards in a draft guidance

On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection Processes and Standards."

This draft guidance was issued to meet requirements set out in the FDA Reauthorization Act of 2017 (P.L. 115-52) (FDARA) which stated that FDA would implement uniform processes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 While much of the information in this draft guidance reflects existing FDA policy for device inspections, the intent of the guidance is to clarify and standardize inspection processes to the extent possible.

Read More: FDA addresses industry feedback on routine inspections by formalizing processes and standards in a draft guidance


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