Device manufacturers at risk for an FDA inspection in the coming months shouldn't expect to see any major changes in the agency's audit approach. That's because its new "program alignment" inspectional scheme isn't ready for primetime – mostly because a training program for investigators still needs to be stood up, an FDA official says.

Under program alignment, facility inspections performed by the Office of Regulatory Affairs will be restructured along commodity-specific product lines, including a team focused on device inspections. This means a majority of firms will likely be exposed to an entirely new, unfamiliar inspectorate, among other big changes.

ORA is the FDA office responsible for all of the agency's field activities.

The bottom line? There are several issues that ORA still has to tackle – including investigator training – before program alignment can be fully realized, FDA's Jan Welch says.

There are several lingering issues that the office still has to tackle before program alignment can be fully realized, many related to FDA investigator education and retention, ORA Medical Devices Program Director Jan Welch said.

ORA must train a large number of investigators in a short amount of time to meet the demands of program alignment, and simultaneously deal with the loss of several highly trained auditors that moved to FDA's device center.

"We want to make sure that all of our staff have what they need when it comes to training and to have adequate access to it," Welch said. "And we need to make sure that the curriculum can react and can change. We don't want to set up the training once and then say, 'Well, this is the way it was in 2016 or 2017.' Rather, the training has to be reactive."

Investigator training for program alignment also "has to be vibrant and it has to recognize changing technology," she said.

FDA has established a training curriculum committee made up of five officials from ORA and five from the Center for Devices and Radiological Health. "This is really exciting. It's a different approach than we've taken in the past to our training needs," Welch said May 6 at MedCon 2016 in Cincinnati.

"But in the end it's really about curriculum development, and that's different than coming up with a list of training courses," she said. "Instead, it's ensuring that we've identified the proper curriculum for our staff – investigators, as well as compliance officers, recall coordinators and complaint coordinators – both at CDRH and at ORA."

Part of formulating an adequate educational program for investigators is by making sure that any training gaps are discovered and bridged.

FDA is "already making some major changes in looking at the courses that we teach to our new investigators," Welch said. Thanks to the agency's own gap analyses, it is retooling and launching new versions of various internal inspection-themed courses.

ORA is worried that it is losing its best and brightest investigators to the device center, adding even more stress on the office ahead of program alignment.

The agency is also on the hunt for qualified instructors to lead classes for investigators. "Not everybody is a good instructor. You might be an SME [subject matter expert], but you might not be very good at delivering the material," Welch said. Right now ORA is determining "how we make sure that we get the right SMEs, work on any new investigator courses, and then find someone who can deliver it."

And, to make matters more complicated: "We really don't have an idea if our training is effective. We've never really determined how to measure that," Welch admitted, noting that training course metrics will be devised as part of program alignment.

With more than 5,000 workers in ORA, changing the way the office is fundamentally structured is akin to steering a giant freighter in a brand-new, uncharted direction.

For example, aside from massive changes for investigators, program alignment calls for FDA's five regional offices to be replaced by three distinct districts within the US. Those districts will house investigators trained to conduct inspections of, among other commodities, medical device facilities.

The three districts will likely be located in areas where there are concentrations of device firms, Sean Boyd, acting deputy director in CDRH’s Office of Compliance, said in March. At the time he called program alignment "the most dramatic change that ORA has experienced, maybe in its history." (See [A#01160328001].)

What Else Will Program Alignment Do?

According to ORA's Jan Welch, program alignment also aims to:

Dig down during inspections to look at device "sub-specialties": "There are nine or 10 sub-specialties that we have identified, including software, sterilization and radiation. We need to make sure that these sub-specialties sync up with our training curriculum to make sure that our investigators have exactly what they need when assessing the inventory in our industry."
Ensure dedicated FDA compliance staff: "Some district offices are already doing this; they've dedicated compliance officers to only device work. But across the board that will be very much the focus in the future."
Streamline internal processes for handling complaints and recalls: "I know what firms' complaints are: They never hear from us. They send stuff in and it's a big, black hole. Well, I don't want that to be the case going forward. We want to give you timely, effective responses and communication. We hear this over and over again, so I think there's work to be done there."
"De-layer" FDA activities: "We can be pretty good when it comes to federal bureaucracy and we have a lot of layers. There can be managerial and operational layers – that's one thing – but there are lots of layers of review when it comes to the activities that we do – probably too much. ORA has its great layers of review, and then when we collaborate with the device center, often on whatever an activity might be, so then there's multiple layers there. So again, how can we de-layer management where it works, and then our activities where it works?"

Highly Trained Investigators Lost To CDRH, Headquarters

Meanwhile, ORA is worried that it is losing its best and brightest investigators to the device center and FDA headquarters, adding even more stress on the office ahead of program alignment. And it all pretty much comes down to money.

"Field staff investigators are at lower pay-grade level than many staff in the centers, and this pay-grade disparity is difficult," Welch said. "This disparity often causes many of our great investigators to go find positions in the center or find positions in headquarters. So we very much do lose very talented and experienced investigators to these other positions."

FDA is addressing the disparity in pay by developing a so-called "career ladder plan" for investigators.

"We're trying very hard to have a dedicated plan and career ladder so people want to have a career in ORA and to stay in ORA. It's a really important part of program alignment, and reorganization in general," Welch said, pointing out that some investigators have seen a bump in pay within the past year.

Process Sign-Off

Despite the changes that are beginning to take shape, program alignment still has to be signed off on by leadership at FDA and in Congress.

"In order to do this type of organization transformation, there is a very formal package that has to go through the agency and be given to Congress," Welch said.

"There's a tremendous amount of activity that has gone into the preparation of this in terms of a brand-new functional statement, and a brand-new crosswalk accounting for every one of those 5,000 employees in ORA: Where do they work today? Where will they align to in the future? So we continue to fine-tune that," she said.

"I'm confident that, a year from now at next year's MedCon, someone from the devices and radiological health program will be able to come and share a tremendous amount of detail on that once we're through the process," Welch added.

She noted that approval for program alignment must come from overarching agency officials, as well as those from ORA and FDA's device center.

And in a final, time-consuming step, the plan has to eventually wend its way through Congress; the government must be informed of the inspectional change but does not have to formally endorse or approve it. Despite such a "non-approval approval," it might be tricky and slow-going, especially during an election year, Welch pointed out.

"But when the package does get approved, we'll be ready with our communication plans," Welch said. "We have to make sure that everybody in FDA and, more specifically, ORA, understands program alignment first. Then we'll roll out a very robust external communication plan to share with industry."

*Follow Shawn M. Schmitt @shawnmschmitt

ORA Device Director: Inspection 'Program Alignment' Scheme Not Ready Anytime Soon; Investigator Training, Retention Pose Challenge For FDA

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