Lowering Device Risks
The FDA, writes DuVal, will become more risk averse as new young biomedical reviewers “continue to see boogeymen in every closet.”
For instance, DuVal says that when there is a “rare event” with a product, the FDA tries to over-regulate the 98% of products that will likely never experience the problem.
“In an attempt to be architects of regulatory perfection,” DuVal writes, the FDA begins to require so much information upfront that innovation is stifled. And the risk aversion is not limited to device submissions, it impacts post-marketing requirements, FDA inspections, etc., as well.
He points out that devices don’t have the big profit margins as drugs, and if more testing and post-marketing requirements are imposed, “we will stifle the introduction of new innovative products.”
Add in new documentaries like Netflix’s “The Bleeding Edge” and reporting by the International Consortium of Investigative Journalists (ICIJ) covering medical device stories on implantable devices, “you get a perfect storm for the request for new, over-reactive laws and regulations.”
One of those stories described how six medical devices (two of them orthopedic—spinal cord stimulators and hip prosthesis) out of more than 190,000 were responsible for a quarter of all the medical-device-related injuries and deaths reported to the FDA from 2008 to 2017.
“These perceived ‘crises’ give FDA (and the plaintiffs’ lawyers) political cover to ask for more regulation.”
Open Mini-PMA?
He says because of their “disdain” for the 510(k) program the FDA would rather have an open mini-PMA standard. “It does not like being tethered to the standard of establishing safety and effectiveness in a comparative sense to another predicate. FDA would rather have a standard of (re-)establishing safety and effectiveness in an absolute and independent sense.”
With that standard, DuVal says, the FDA can ask for any amount of data it wants. “FDA should take into account what it already knows about a given device, predicate family, technological platform, and/or material, etc. The idea behind a predicate is precedence, i.e. not unnecessarily re-inventing the wheel, or asking for data on what is known and can be scientifically extrapolated.”
He concludes: “Think of the myriad of post-marketing requirements that have been put into place or are coming, not by law or regulations, but by FDA guidance. It is an avalanche of (over-)regulation.”
Here Comes the Office of Product Evaluation and Quality
Jeff Zumhofe, a quality system consultant featured in DuVal’s note, says the CDRH launched pilots in 2018 of its Total Product Life Cycle (TPLC) approach across the organization and will continue to push for those changes in 2019. Full implementation of the restructuring plan is anticipated in early-mid 2019 after approval by FDA, HHS and Congress.
A big deal is the planned change to merge the Office of Compliance, Office of Device Evaluation and Office of Surveillance and Biometrics into one “Super Office,” the Office of Product Evaluation and Quality (OPEQ).
OPEQ will consist of three offices: Office of Health Technology (OHT), Office of Clinical Evaluation and Analysis (OCEA), and the Office of Regulatory Programs (ORP). CDRH will organize along product category groupings intended to better facilitate access to product lifecycle data and thereby improve efficiency and collaboration.
The ORP will have responsibility for submission support, establishment support (registration and listing, audits, and FDA inspections), and market intelligence (complaints, MDRs, recalls, product shortages).
Zumhofe tells clients to be aware that the Office of Medical Device and Radiological Health Operations (OMDRHO) within ORP has established three geographically defined Divisions, and the previous line of follow-up with the local District has now been shifted to the appropriate Division contact.
