Rule On Pediatric Device Data Oversteps FDA Authority - AdvaMed

Article preview from "The Gray Sheet" - June 21, 2010

An FDA rule requiring pre-market device submissions to include additional data on pediatric patients oversteps FDA's statutory authority, trade group AdvaMed says.

Rule On Pediatric Device Data Oversteps FDA Authority - AdvaMed

Article preview from "The Gray Sheet" - June 21, 2010

An FDA rule requiring pre-market device submissions to include additional data on pediatric patients oversteps FDA's statutory authority, trade group AdvaMed says.

The March 31 direct-to-final ¹ rule is intended to implement requirements in the Pediatric Medical Device Safety and Improvement Act, passed in 2007 as part of the broader FDA Amendments Act.

Those provisions require humanitarian device exemption (HDE) applications, PMA applications and PMA supplements for new intended uses to include "readily available" information on pediatric populations that suffer from the disease or condition addressed by the sponsor's device.

Firms must also submit information on the number of pediatric patients who might be treated with the device.

AdvaMed charges that the language in the FDA rule goes a step too far, requiring sponsors to include information on "potential" or "possible" pediatric uses of their devices.

The rule amends sections of 21 CFR part 814 to require "the submission of additional information concerning potential pediatric uses" and amends the regulation's purpose to add the goal of ensuring that PMAs include information on "actual and potential" pediatric uses of devices.

But the language in the FDA Amendments Act was limited to "known" pediatric uses of devices, AdvaMed asserts.

"FDA is using section 515(a)2 to change the purpose of its regulation of medical devices and to impose burdens on manufacturers not contemplated or enacted by Congress," the trade group writes in June 15 ³ comments.

The legislation does not require sponsors to submit information on "any pediatric subpopulation that could possibly suffer from the disease or condition" or to "guess the possible number of pediatric patients that could be affected by the disease," AdvaMed emphasizes.

The trade group urges FDA to remove all references to "possible" or "potential" pediatric uses from the March 31 rule.

Comments on the rule were due June 15. The rule goes into effect Aug. 16, barring any "significant adverse comments," FDA originally said.

Rule Should Not Apply Retroactively - Comments

Under the rule, FDA can request that PMA applications or supplements be amended to include the required information about pediatric subpopulations.

AdvaMed urges FDA to clarify that this requirement applies only to PMAs and PMA supplements submitted after the effective date of the 2007 FDA Amendments Act.

"FDA cannot require under its regulations that the holder of a PMA that was submitted prior to the effective date of the law submit a PMA supplement containing pediatric use information," the group writes, because Congress did not specify that the law would apply retroactively.

Too Controversial For Direct-To-Final Rule?

Finally, AdvaMed argues that the direct-to-final route was inappropriate for regulatory changes of this magnitude.

FDA said the direct-to-final approach was appropriate because it concerned "noncontroversial amendments and minor corrections to existing regulations."

AdvaMed disagrees. "These proposed revisions are neither minor nor noncontroversial," the group writes. "Requiring sponsors to provide speculative information ... is unduly burdensome and without a legal basis."

Failure to submit the necessary pediatric information to FDA could delay approval of a PMA, HDE or PMA supplement, AdvaMed notes, which is "a serious consequence."

The group requests that FDA withdraw the direct-to-final rule and proceed with normal notice and comment procedures for proposed regulations.

- Jessica Bylander

 

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