FDA Releases Draft Guidance for Medical Device Company Inspections!

The U.S. Food and Drug Administration (FDA) on3month28day released a draft guidance for inspecting medical device firms, aiming to implement unified inspection processes and standards for domestic and foreign medical device firms.

       FDAupdated the processes and standards for inspecting medical device firms (excluding for-cause inspections) to ensure consistency and established standard timeframes for inspections of medical device firms.FDAstated,“FDAinvestigators, through the implementation of consistent inspection methods, can provide information for firm preparation and set basic communication and time expectations for both parties”Also identifiedFDApractices that investigators and medical device firms should adopt to ensure inspection continuity. In addition, the draft provides exceptions to the inspection processes and standards, estimated timeframes for the inspection process, and certain record requests to be provided by medical device firms in advance of on-site inspections. This draft is in line with2017year'sFDAFood and Drug Administration Reauthorization Act (FDARA) requirements.

        FDAinspections generally last3-6business days; however, the length of the inspection is affected by many factors (such as the nature of any non-compliances found during the inspection) and may be extended in certain circumstances. According to the unified inspection processes and standards,FDAdomestic inspections will be announced five days in advance. For foreign inspections, there may be delays due to local country licensing requirements.“When time and circumstances permit,”，FDAinvestigators should“take all reasonable steps to discuss all non-compliances (observations) with the medical device firm’s management during the inspection; such discussions may also take place daily to minimize errors and misunderstandings.”

        FDAThe Center for Devices and Radiological Health (CDRH) released a draft guidance that aims to establish a new standardized mechanism for medical device firms to request non-binding feedback fromFDA 483form observations.FDAon the actions they plan to take to address issues raised inFDAThe release of this draft guidance is also in accordance withFDARASection702of the Reauthorization Act.CDRHThe report indicates that from2007year2017to243year, the number of annual inspections of foreign medical device firms increased by46%%, and domestic inspections increased byFDAThis highlights

       FDAthe urgent need to implement the new guidance to improve coordination before and after the inspection process.FDARARecently, data points on drug and device approval inspections have begun to be compiled in annual reports in accordance withFDAthe Reauthorization Act.2018In3monthFDAof35year, the annual report indicated that the time elapsed between issuing an inspection request and initiating the medical device firm inspection was

      days.CDRHMeanwhile,the Biostatistics Department is developing a new software tool (calledBLISS