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Patricia O'Connell
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Sonali Gunawardhana Discusses Draft FDA Guidance on Medical Device Reporting

The Silver Sheet
August 27, 2013

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was interviewed by The Silver Sheet for an article in its August issue about the U.S Food and Drug Administration’s (FDA) draft guidance for manufacturers on Medical Device Reporting (MDR) rules.  The guidance, if finalized, will explain the FDA’s current thinking on how to comply with reporting requirements for certain adverse events linked to the use of medical devices.

Ms. Gunawardhana was among attorneys who told The Silver Sheet the draft guidance would be onerous for companies that would have to submit more requests for exemptions from the MDR requirements—in part because of the removal of a “two-year rule” for device malfunctions.  Under an FDA guidance issued in 1997, if a malfunction leads to a death or serious injury, the manufacturer must report to the agency any subsequent malfunctions of the same type—unless two years pass without the malfunction causing or contributing to another death or serious injury.

The new draft guidance doesn’t mention a two-year rule.  Rather, it advises manufacturers to document, as part of a request for a reporting exemption, that a device malfunction hasn’t caused any additional deaths or serious injuries.

The FDA may have decided that removing a company’s reporting responsibility based on a pre-designated time period is arbitrary in an era of rapidly evolving medical devices, Ms. Gunawardhana said.  “FDA probably believes that after two years, problems with devices fall off manufacturers’ radars, and they probably shouldn’t have,” she said.

Also, “the reality is that FDA isn’t looking at the same devices that they were looking at 10 or 15 years ago, and there’s more of a chance that the agency is not getting [useful postmarket] information because it exempts a firm because of the two-year mark,” Ms. Gunawardhana added.  “I think the agency, in order to get a better handle on it, said, ‘Let’s take out this timeframe and let’s do it on a case-by-case basis.’”

She predicted that the FDA is unlikely to restore the two-year rule in the final guidance.  However, it might provide “information about how much time FDA will take to make a decision for exemption, or it will be more clear about the agency’s process for making an exemption decision,” Ms. Gunawardhana said.  “But the agency will probably leave it up to the manufacturer to actually ask for the exemption.  It’s not going to say, ‘On this date, you can automatically ask for an exemption.’”

Ms. Gunawardhana noted that guidance documents, unlike regulations, cannot be enforced by the FDA.  “They’re nonbinding on both the industry and the agency,” she said.  “It’s the FDA’s best thinking.  If firms can come up with a way of getting to the end goal by doing things differently, the agency has to accept it,” as long as a company makes sure its approach does not violate the underlying regulations.