FDA 2010 Weather Forecast: Tougher Regulatory Scrutiny, More Medical Device Inspections

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

As weird weather slaps both U.S. Coasts [flooding in Southern California, hail storms in the South], the forecast at the FDA looks like medical device firms could be in for some heavy stuff of their own in 2010. This isn’t Chicken Little saying the sky is falling here. Let’s review a few FDA actions in the past several weeks and probe a bit for their possible significance to medical device firms.

For starters, a relatively casual-sounding entry on the FDA’s transparency blog could signal the beginning of much more robust scrutiny and inspections for medical device companies.

Here’s a little of what it says,  “FDA seeks input on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly. Disclosure of full inspectional observation reports would still require the same review for non-public information as it does now.”

Depending on how this in interpreted and ultimately implemented, it could mean that medical device companies are going to see a lot more inspectors doing a lot more inspections.

So far, most comments favor the FDA doing this, though one anonymous commenter raises a good point from the medical device manufacturer side:  “Since FDA-483s are evidence gathered for potential legal action, it may be a violation of a company’s legal rights to have a FDA-483 released without a legal review and opportunity for a response. Also, some FDA-483s contain annotations about findings corrected during an inspection, etc. What would be the purpose in releasing such information?

Occasionally, there have been errors in findings by FDA investigators that have to be corrected after the original FDA-483 is issued. What would be the opportunity to publicize the mistakes made by FDA in correcting these errors?

The due process accorded in the current process was placed there for a purpose. Has anyone explored why the current process is in place?

Certainly, the improvements to ‘protect the public health’ are admirable, but what is the real purpose of this move?”

That’s a fair question. We encourage your comments. I think it could spell trouble for medical device firms.

“This is big and could mean more inspections [and legal exposure] for medical device companies,” agrees my blogging colleague and Bryan Cave law firm Partner Mark Mansour.

He also cites the appointment of Joshua M. Sharfstein to be the principal deputy commissioner of the FDA after serving as acting commissioner for Food and Drugs from March 29 to May 25, 2009.

“Sharfstein is incredibly enforcement minded,” says Mansour. [Look for a more in-depth legal analysis of this from Mark’s blog later this week]. “He’s giving the push” for more enforcement of medical device companies.

At the same time, CDRH has issued its Fiscal Year 2010 Strategic Priorities report – and it hints an awful lot about hiking enforcement activity to better protect the public’s health.

But wait, there’s more.

The FDA recently scheduled a public meeting on Feb. 18 to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.

Last September, the agency announced it had asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process. The IOM study is not expected to conclude until March 2011.

In the meantime, the FDA has convened its own internal working group to evaluate and improve the quality and consistency of the agency’s decision-making in the 510(k) process as well as its administration of the program. The February meeting will support the efforts of the agency’s internal working group.

The Feb. 18 meeting will run from 8 a.m. to 5:30 p.m. at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Md. If you want to attend or otherwise participate you have to register by 5 p.m. on Feb. 12, 2010. The agency is accepting written or electronic comments by March 5, 2010.

The meeting will be Webcast live here.

We’re not even through the first month of 2010 yet, and it already feels like a lot has happened – and there’s almost certainly more to come.