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Guidance for expediting premarket submissions updated

Device Regulation Alert: Safety, Compliance and Reimbursement News, March 10, 2008

Updated guidance on expedited review for premarket submissions for medical devices explains the criteria and standard procedures for expedited review and incorporates changes made under the Food and Drug Administration Amendments Act of 2007. The new guidance supercedes a 2003 version.

Devices that treat or diagnose life-threatening conditions or satisfy unmet medical needs are appropriate for expedited review. A device may serve unmet needs if:

• It is new technology that exceeds existing technology
• No other approved treatment exists
• It has "significant, clinically meaningful advantages" to other approved treatments
• Patients will benefit if the device is available

Manufacturers should discuss with the FDA as early as possible any devices that might qualify for expedited review. Requests for expedited review should be made in writing and include an explanation of why the device qualifies.

Gaining expedited review status means the application moves to the front of the line and could have more resources devoted to its review, but doesn't guarantee the process will actually conclude faster. Several factors can still slow the process, such as:

• Facility not ready for inspection
• Complex issues that require in-depth review
• Manufacturer's failure to provide sufficient scientific data

Therefore manufacturers should devote sufficient resources to the device review to promptly address any scientific or regulatory issues that arise.

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