FDA Outlines Balance Between Premarket, Postmarket Device Studies

FDA Outlines Balance Between Premarket, Postmarket Device Studies-insidehealthpolicy: FDA issued final guidance giving specific examples of when the agency feels it is appropriate to use postmarket data in order to speed up the device premarket approval application (PMA) process. The guidance dovetails with a separate guidance, also issued Wednesday (April 8), launching the agency's Expedited Premarket Approval (EAP) program for medical devices intended for unmet medical needs, which is mirrored after expedited pathways for drugs.

FDA Guidance Allows Limited Foreign Data To Approve Devices With Postmarket Caveat

FDA Guidance Allows Limited Foreign Data To Approve Devices With Postmarket Caveat-thegraysheet: As FDA puts more emphasis on postmarket data collection in its PMA approval process, the agency has released a final guidance on balancing premarket and postmarket studies.

Planning Board Proposes Postmarket Device Surveillance Timeline

Planning Board Proposes Postmarket Device Surveillance Timeline-thegraysheet: A planning board created to develop a framework for a new U.S. medical device surveillance system has proposed a seven year plan on how to get the system up and running, which will include creating incentive systems for stakeholders as well as reducing the burden of recording and managing device data.

Brookings Lays Out Seven-Year Plan To Utilize Medical Device Postmarket Surveillance System

Brookings Lays Out Seven-Year Plan To Utilize Medical Device Postmarket Surveillance System-insidehealthpolicy: A new Brookings Institution report sets out a seven-year plan for stakeholders to fully adopt and implement an effective postmarket surveillance system for medical devices (MDS).

Planning Board Proposes Postmarket Device Surveillance Timeline

Planning Board Proposes Postmarket Device Surveillance Timeline-thegraysheet: A planning board created to develop a framework for a new U.S. medical device surveillance system has proposed a seven year plan on how to get the system up and running, which will include creating incentive systems for stakeholders as well as reducing the burden of recording and managing device data.

Premarket-Postmarket Data Collection On FDA's Device Guidance Agenda

Premarket-Postmarket Data Collection On FDA's Device Guidance Agenda-insidehealthpolicy: FDA has pegged as “A-list” priorities 12 device guidance documents it hopes to finalize this year that include guidances on balancing premarket and postmarket data collection for devices subject to premarket approval; and on crafting 510(k) submissions for devices that include antimicrobial agents.

What Makes The Ideal Registry? Focus, Transparency, Versatility, Groups Say

What Makes The Ideal Registry? Focus, Transparency, Versatility, Groups Say-thegraysheet: Registries are not for every device, but when they are warranted, they should be tightly focused and very transparent, according to Sept. 3 recommendations from groups closely engaged in FDA’s efforts to upgrade the U.S. postmarket device surveillance system. The report from the Pew Charitable Trusts, the Blue Cross Blue Shield Association and Cornell University researchers, argues that the U.S. needs a stronger system of registries to answer safety and effectiveness questions that can’t be addressed by size-limited premarket studies. But it also readily acknowledges the limits of registries and that they can be very resource intensive.

CDRH Details Path Forward For National Post-Market Surveillance System

CDRH Details Path Forward For National Post-Market Surveillance System-graysheet: The device center released an updated plan for post-market surveillance reforms, featuring a planning board that will establish a governing structure for the new system, as well as implementation dates for various post-market projects.

FDA To Issue Final Device Post-Market Surveillance Plan In February

FDA To Issue Final Device Post-Market Surveillance Plan In February-Thegraysheet: The device center is moving full speed ahead with plans to publish the final version of its national device post-market strategy by late February or early March, after receiving positive feedback on the proposed plan last year. The center will also choose an outside group to run its nascent Medical Device Epidemiology Network.

FDA Pushes Device Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated

FDA Pushes Device Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated-InsideHealthPolicy.com:
FDA device officials are pushing for a national postmarket surveillance monitoring system that emphasizes Unique Device Identifiers and their incorporation into electronic health records, device registries, modernized adverse event reporting and new methods to analyze postmarket information, laying out the plan in a paper released late last week and discussed at a public meeting Monday (Sept. 10).

FDA outlines postmarket surveillance plan ahead of public meetings

FDA outlines postmarket surveillance plan ahead of public meetings-massdevice.com:


Ahead of a 4-day public meeting blitz, the FDA released a preliminary proposal for strengthening medical device post-market surveillance.

FDA releases new guidance on postmarket surveillance | MassDevice - Medical Device Industry News

FDA releases new guidance on postmarket surveillance - MassDevice: The FDA is on a roll, releasing yet another draft guidance on medical device regulations this week, this time providing an overview of the postmarket surveillance program and procedural information on how companies should comply.