'A Sea Change': Device Center Compliance Chief Touts US FDA's Benefit-Risk Concepts – But Will Manufacturers Buy In?
FDA compliance head Robin Newman is asking manufacturers to share information on troublesome devices to help the agency make benefit-risk decisions that weigh product availability and regulatory compliance. But an industry survey finds that only 17% of firms are willing to hand over such potentially sensitive information. Nevertheless, the agency believes it's vitally important for device-makers to be more forthcoming with data that supports well-informed benefit-risk conclusions, made in the best interest of patients and manufacturers. Driving the data-sharing discussion is a December guidance from FDA that outlines a broad framework for considering benefit-risk factors – a document that Newman says is "a sea change" for how industry and the agency can work hand-in-hand on benefit-risk analyses.
You may also be interested in...
Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971
The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest redo of ISO 14971, the voluntary standard that instructs device-makers on how to best put together a risk management program. Regulators – including US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance issues. And Jos Van Vroonhoven, convener of a joint working group that revised the standard, says a more global regulatory emphasis on risk management and a desire to clarify the document in general led ISO to revise the standard. Also: Van Vroonhoven identifies four updated clauses in the revamped standard that firms should keep a sharp eye on.
Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
The pursuit of quality can be a daunting task for device-makers. One wrong step can cause costly product recalls affecting patient health – among other troubles tied to poor quality products and processes. To help firms move toward a goal of best-in-industry quality, US FDA, through its Case for Quality initiative, has convened a pilot program to measure a manufacturer's capability and maturity to help put it on a path to continuous improvement. The pilot uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method, developed jointly by FDA, industry and CMMI Institute.