FDA Is Revamping Clearance Procedures for Medical Devices

FDA Is Revamping Clearance Procedures for Medical Devices-wsj: The Food and Drug Administration is significantly revamping the way it clears most medical devices for U.S. marketing, planning to rely far less on comparisons with much older products already on the market.

First Glucose Meter Cleared For Hospital ICUs As FDA Continues Work On Guidance

First Glucose Meter Cleared For Hospital ICUs As FDA Continues Work On Guidance-thegraysheet: The clearance does not necessarily resolve the broader debate about regulatory standards for hospital glucose meters going forward. Lias stressed that the January document is draft guidance and that it did not play a role in FDA’s review of Nova’s submission. “It was not a factor at all in this clearance,” the FDA official told “The Gray Sheet.” An assessment based on the standards described in the draft guidance “was not even done because it is draft guidance,” she said. “It is not something that is applied or used.”

More PMAs Would Results From FDA’s Classification Proposal, AdvaMed Warns

More PMAs Would Results From FDA’s Classification Proposal, AdvaMed Warns-thegraysheet: The FDA’s proposal to amend and clarify its regulations on classification and re-classification of medical devices could fundamentally change the classification process and result in more devices having to undergo the more stringent PMA review, warns medtech industry association AdvaMed. In particular, the propose rule, if implemented in its current form, would substantially rewrite the definition of high risk, class III devices and move more products from 510(k) to PMA standards, AdvaMed argues.

US regulators to exempt some Class I and II medical devices from 510(k) premarket review

US regulators to exempt some Class I and II medical devices from 510(k) premarket review-massdevice: The US Food and Drug Administration plans to exempt certain medical devices from 510(k) premarket notification requirements due to what the agency considers their well-established safety and effectiveness.

FDA issues new guidance on medical device user fee refunds and exceptions

FDA issues new guidance on medical device user fee refunds and exceptions-massdevice: The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review.The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund.

Primer on U.S. FDA's new 510(k) refuse to accept policy

Primer on U.S. FDA's new 510(k) refuse to accept policy-massdevice: The US Food and Drug Administration's revised Refuse to Accept (RTA) policy (links to PDF document) for 510(k) applications that lack all required documentation is now in effect. Medical device manufacturers planning to undergo the premarket notification process should familiarize themselves with steps necessary to get their applications back on track in the event that they receive an RTA notice from the FDA.

FDA Claims Short-Term Success For Its Pre-Market Device Reforms

FDA Claims Short-Term Success For Its Pre-Market Device Reforms-healthnewsdaily: With many of CDRH’s 2011-announced 510(k) and science reforms at least partially implemented, the device center says it is seeing tangible, positive results, citing a turnaround on multiple measures of review performance following a peak in negative efficiency trends in fiscal year 2010

FDA proposes new 510(k) pre-review to cut out incomplete applications

FDA proposes new 510(k) pre-review to cut out incomplete applications-massdevice.com:
The FDA revises its 510(k) application policy and issues a new basic administrative checklist to pre-assess submissions for a certain level of completeness before passing them on for agency review.

IOM's 510(k) Reform Proposals To Have Limited Impact On MDUFA Talks

IOM's 510(k) Reform Proposals To Have Limited Impact On MDUFA Talk - InsideHealthPolicy.com: "The Institute of Medicine's controversial recommendation to scrap the 510(k) device clearance process is unlikely to affect stalled medical device user fee negotiations, sources said, noting that even though FDA indicated it will not use the expert group's proposal, there are still unknown regulatory factors facing industry that are not addressed by the report and could fuel hesitation by product manufacturers to enter a five-year deal. FDA meanwhile pushed forward in the talks, telling device industry stakeholders in a recent meeting that it wants a user fee agreement by the end of the month to meet statutory deadlines, according to meeting minutes."

FDA's 510(k) Guide Could Mandate Off-Label Use Listing, Impact Practice Of Medicine

This guidance is part of FDA's overall review of the 510(k) process, which is expected to culminate later this week with recommendations from IOM:

FDA's 510(k) Guide Could Mandate Off-Label Use Listing, Impact Practice Of Medicin - Inside Health Policy: "FDA's new policy outlining when 510(k) clearance applications are necessary for modified medical devices reverses the agency's stance of not requiring submissions when adding home use indications to labels and delves into the practice of medicine by requiring manufacturers to factor potential off-label uses into their design changes, an industry attorney said. The policy -- outlined in a guidance document released Tuesday (July 26) -- is part of the agency's plan to revamp the 510(k) process, with a highly anticipated Institute of Medicine report due out Friday (July 29) that is expected steer how the agency reforms the device clearance pathway."

New FDA study: Insufficient 510(k) submissions causing bulk of 510(k) review delays | MassDevice - Blog entry

Internal FDA study reveals deficiencies in 510(k) process and highlights areas for potential improvement.

New FDA study: Insufficient 510(k) submissions causing bulk of 510(k) review delays - MassDevice: "A new analysis of 510(k) premarket review timeframes by the US Food and Drug Administration cites response times from companies to additional information requests as the key causes of review delays."