FDA Reforms: Senate v. House

Chart symbols indicate provisions, culled from the latest available drafts as of May 11, that are distinctly different (≠), essentially equivalent (=) and that appear to take different legislative approaches to a similar result (~). Not shown is the core FDA-device industry user fee agreement, which is equivalent in both versions. (See in this issue, Also see "Fireworks Kept At Bay As Congress Pushes To Enact FDA Reforms By July 4" - Medtech Insight, 14 May, 2012..)

Senate

House

Guidance development ≠

Clarifies that “notice to industry” letters and other notices that set forth changes in interpretations of a regulation or policy are subject to FDA good guidance practices.

Requires 30-days public notice before FDA issues a draft guidance, providing a period for stakeholder consultation, or, if not possible, a three-month public consultation period after a guidance is issued. Also requires that all draft guidances be finalized within 18 months after the close of the comment period, with an option to extend the deadline by up to six months.

Device risk reclassifications ≠

Allows FDA, based on new information, to change the classification of a device by administrative order instead of by regulation.

Requires FDA to issue a schedule within 90 days for either reclassifying or requiring PMAs for the remaining class III pre-amendments devices and to issue rules for pre-amendments devices that will require PMAs within one year.

“Least burdensome” provision =

Clarifies that data requests be the “minimum” required to demonstrate safety and effectiveness for a PMA or substantial equivalence for a 510(k).

Same reform

Post-market orders ≠

Codifies FDA’s authority to require, as a condition of pre-market approval, post-market study of the device.

No provision

Clarifies FDA’s authority to order post-market surveillance for specified class II and III devices either at the time of approval/ clearance or thereafter; a company would be required to start the surveillance within 15 months.

No provision

Sentinel Initiative =

Requires FDA to extend its Sentinel post-market risk identification and evaluation system to include medical devices.

Same reform

Unique device identifiers ~

Includes new deadlines for FDA to implement mandatory UDIs: to issue a proposed regulation by Dec. 31, 2012, a final regulation within six months following close of a comment period, and to implement the rule within two years after finalized for implantable, life-saving and life-sustaining devices.

Requires FDA to issue a UDI regulation within 120 days after enactment.

Recalls =

Requires FDA to create a program to assess information submitted or reported pursuant to device recalls, removals and corrections, and to use this information to identify strategies for mitigating health risks from defective or unsafe devices. FDA would be required to clarify procedures for device recall audit checks and develop criteria for assessing correction or removal actions. FDA must document the basis for termination of a recall.

Same reform

Review decision rationale ~

Requires FDA to provide to the sponsor a summary of the scientific and regulatory rationale for a decision to deny clearance of a 510(k) notification, approval of a PMA application or disapproval of an IDE application. Establishes a supervisory review process with specified timelines.

Essentially the same, except the House language references “any significant decision,” rather than specifying an application denial. It also specifies that FDA should document “significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.”

Investigational device exemption trials ≠

Allows FDA to issue a clinical hold prohibiting the sponsor of a medical device from conducting a clinical investigation using the device if FDA determines the device represents an unreasonable risk to the subjects’ safety or for other reasons established by regulation.

No provision.

No provision.

Adds a statement that FDA may not reject an IDE because the agency thinks the trial will not be sufficient to support device clearance, de novo classification or approval of the device or may not meet a requirement, or “because the Secretary determines that an additional or different investigation may be necessary to support approval or clearance of the device.’’

De novo reform =

Allows sponsors to submit a de novo petition for low-to-moderate-risk devices without first receiving a not-substantially-equivalent decision on a 510(k).

Same reform.

Humanitarian device exemptions =

Expands the exemption from the prohibition on profit for HDE devices to products intended for use in adults if the device is intended to treat or diagnose a disease or condition that does not occur in pediatric patients, or that occurs in such low numbers of children that the device’s development is impossible, highly impracticable or unsafe. Clarifies that the annual limit on distribution is the number of devices needed to treat 4,000 patients.

Same reform

Pediatric reauthorization ~

Reauthorizes the profit allowance for HDE devices with a pediatric indication and reauthorizes a demonstration grant program for nonprofit pediatric device consortia, funded at $4.5 million per year, rather than the current $6 million per year.

Reauthorizes the profit allowance for HDE devices with a pediatric indication and reauthorizes a demonstration grant program for nonprofit pediatric device consortia, funded at $6 million per year. Also, requires FDA to issue a proposed rule by December 2012 and a final rule by December 2013 requiring device companies to include available information on affected pediatric subpopulations in pre-market submissions.

Third-party reviews and inspections ~

Reauthorizes, through Oct. 1, 2017, accredited third-party review of 510(k) submissions and third-party inspections of factory, warehouse, or manufacturing or processing establishments.

Reauthorizes, through Oct. 1, 2017, accredited third-party review of 510(k) submissions and third-party inspections of factory, warehouse, or manufacturing or processing establishments. Also, sets requirements for periodic reaccreditation every 3 years for review program.

510(k) modifications ~

Requires FDA to withdraw its recent draft guidance on 510(k) modifications.

Requires FDA to withdraw its recent draft guidance on 510(k) modifications, and requires FDA to submit a report to Congress within 18 months of the law’s enactment regarding when a 510(k) should be submitted for a modification or change. FDA must refrain from finalizing a new guidance document until one year after issuing the report.

Custom devices =

Clarifies FDA’s policy on customization of devices for small (five or fewer per year), unique populations, and requires a guidance document.

Same reform

Global harmonization ~

Requires FDA to work with other countries’ regulatory authorities to facilitate use of foreign data and reduce duplication of studies needed for pre-market approval (for devices and drugs).

Allows FDA to enter into agreements with Australia, Canada, Israel and the EU on methods to harmonize device regulatory requirements for inspections and common international labeling symbols. It also urges FDA to collect stakeholder input and provide public updates of its activities with the International Medical Device Regulators Forum and other harmonization bodies.

Conflict of Interest Rules for Advisory Committees ~

Eliminates the annual cap on FDA conflict-of-interest waivers; makes public an FDA annual report on waivers; and requires a guidance document.

Eliminates the annual cap on FDA conflict-of-interest waivers; makes public an FDA annual report on waivers. No requirement on guidance document.

Laboratory-developed tests ≠

No provision.

Requires FDA to notify Congress at least two months before issuing any draft or final guidance on the regulation of laboratory-developed tests.

Health information technology ≠

No provision.

Requires FDA, in consultation with HHS, the National Coordinator for Health Information Technology, and the Federal Communications Commission, to issue a report to Congress with recommendations for a health information technology regulatory framework.

Source: The FDA Safety and Innovation Act, approved by the Senate Health, Education, Labor and Pensions Committee April 25; the FDA Reform Act, approved by the House Energy and Commerce Committee on May 10.

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