RAPS 2015 State of the Agency Keynote, Stephen Ostroff, MD, Acting Commissioner, FDA spoke about a critical realignment at FDA, the synchronization of the Field FDA and Central FDA. For years industry has struggled with FDA inspectors being 'generalists'. This meant that inspectors one week would inspect a drug facility, the next week an orthopedic facility and so on. Thus 'generalists' inspectors arriving to an industry facility without in-depth understanding of the specific device, product line and manufacturing processes, often resulted in a 'checklist' driven inspection. Yet over the years products have become complex while Industry has evolved with greater manufacturing Best Practices specificity. Industries time spent during inspections has often been viewed as ineffective and inconsistent. Additionally, FDAs focus on Case for Quality points to the need for high quality systems. Only an inspector with specific knowledge will be able to detect where there are real quality issues.
Listening to Mr. Ostroff, and considering the various efforts FDA CDRH has made on Case for Quality, it means that Industry will need to be prepared for inspectors that understand the nuances of an industry and inspect for quality system, rather than 'just a checklist' culture. Specialized Inspectors means they are familiar with the device and product lines, and thus have the ability to leverage the specific Industry knowledge. The upside is that industry will be able to spend time constructively, the challenge is a higher sophistication to the inspections. Consider Risk Management within Quality System Review; the mechanisms to identity and manage risk includes internal and external sources. Having efficient processes to monitor overall industries failures, such as Recalls, as an input to the risk identification during Design Review and Product Review meetings becomes important. ClearRoadmap™ Search module allows clients quickly and cost effectively search medical device data at an unprecedented level. Creating a tailored "Recalls search" for devices using criteria such as: Indication of Use (e.g. stent) and/or biomaterial (e.g. titanium), will return a list of devices in seconds. Client can select a device from the list to view up to 80 data fields such as Usage, Indication of Use, Recall details, Manufactures information. With ClearRoadmap™ Web-Service API clients can build the search into their Quality Management platform or even an Excel® spreadsheet, to conduct their own analytics, as FDA realigns their Field Offices.
The FDA Program Alignment of field specialist to align with their FDA's Center and divisions will be implemented over the next two years. District Offices will no longer serve 'all products', but Specialize in those that are in their area. This is good for all parties. Industry will have inspectors that understand the industry and thus the less time will be spent brining the inspector up to speed. FDA will benefit from tighter communications with their Center and divisions understanding of the device, product line and facility history. Patients, the ultimate beneficiary, will benefit from the tighter coordination within FDA and more specialized inspectors with higher consistency across industry, thus the 483 letters will have greater meaning.
-- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™