US FDA Inspections & FDARA: Will New Law Light The Way For Investigators? Maybe, Experts Say
The FDA Reauthorization Act, enacted last month, includes provisions that aim to improve FDA's inspection process, including putting a stop to arbitrary audit scheduling by the agency – a practice that can cause a facility inspection to drag on for weeks at a time. FDA has until early 2019 to draft a guidance document that lays out how it will ensure a more uniform inspection process that ensures greater parity between foreign and domestic audits. Steps mandated by the new law include notifying firms in advance of records that will be requested during an inspection and specifying a window of time for investigators to conduct the onsite inspections. But industry experts are of two minds as to whether any substantial changes will result from the new law. Also: FDA device center Director Jeff Shuren weighs in.
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Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience
Quality, compliance and regulatory officials at the three large device firms – along with their peers at Steris and CVRx – open up about appraisals conducted at their facilities under a voluntary US FDA pilot program that uses Capability Maturity Model Integration (CMMI) to measure the capability and maturity of their manufacturing sites. Along with providing a step-by-step walk-through of the assessments, the officials explain how a CMMI appraisal is nothing like a typical regulatory audit. They also talk about the types of benefits they're seeing (hint: cost-savings, and better manufacturing capability and quality), and how they network via monthly conference calls linked to the pilot. Also: Baxter Healthcare explains why it made its own maturity model, and how it plans to eventually replace the homemade tool with CMMI at all its facilities.
The agency is considering ways to leverage outputs from the increasingly popular Medical Device Single Audit Program in new and diverse ways, including accepting MDSAP audit results instead of conducting its own pre-market approval inspections.
Device companies have an opportunity to leverage several major reforms and initiatives that are getting off the ground related to global facility inspections. But firms must constructively engage with the new programs to reap benefits, say Akin Gump attorneys and former top US FDA officials Nathan Brown and Howard Sklamberg in this guest column.