Business, Center for Devices and Radiological Health, draft guidances, FDA, Federal Food Drug and Cosmetic Act, Food & Drug Administration, Medical device, PMA, Premarket Approval, Technology
FDA Aims To Smooth Premarket Review process | Bloomberg BNA.
Wednesday, August 22, 2012
FDA Aims To Smooth Premarket Review process
In the world of medical device reviews, timing is everything. Device manufacturers often claim FDA does not review their premarket applications quickly enough. For its part, FDA has said some of the blame lies with the companies that submit applications missing key information. It’s a time consuming process to keep sending companies requests for more information. FDA officials have even said they’ve come across applications that aren’t even written in English.
In an effort to improve overall review times and enhance the quality of submissions, FDA in the past month has released a pair of draft guidances for industry and agency staff. The documents are pretty similar, but each covers a different type of premarket review. One addresses the idea of a “refusal to accept” policy for 510(k) applications, and the other addresses essentially the same idea for premarket approval (PMA) applications. The 510(k) process is how most low and moderate-risk devices reach the market, and requires only that they be proven substantially equivalent to a device already being sold. PMAs generally require clinical trials, and are for high risk devices.
Both guidances outline the minimum requirements manufacturers must include in the respective premarket applications. The PMA guidance includes two checklists: acceptance criteria and filing criteria. If the manufacturer doesn’t meet the acceptance criteria, the FDA reviewer can send the application back within 15 days without having to look at any other components. The 510(k) “refusal to accept” policy is similar– if the manufacturer doesn’t meet specific criteria (outlined in a checklist), the reviewer can send it back and ask for the correct information before filing the application for a more substantial review.
Both guidances are still just drafts with comment periods, but FDA hopes they will lead to a much more efficient use of agency resources and a higher quality of device submissions. Comments on the 510(k) guidance are due Sept. 27, and comments on the PMA guidance are due Sept. 14.
- FDA – Overview of Medical Device Regulation > Information about MDUFA III (earlsview.com)
- Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions (earlsview.com)
- New FDA guidance on considerations used in device approval (earlsview.com)
- Dems urge FDA to boost medtech recall database | MassDevice.com (earlsview.com)
- Pre Market Approval – Why does the Law shelter Smith & Nephew & others like them? (earlsview.com)
- FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… (earlsview.com)
- FDA to guide device makers on marketing application – chicagotribune.com (earlsview.com)
- Smith & Nephew BHR – Food and Drug Administration, HHS (earlsview.com)
- Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL (earlsview.com)
- Preemption in the Garden State (druganddevicelaw.blogspot.com)
I dropped Nathaniel a friendly note suggesting he read the notes of the FDA meeting held on September 8, 2005 held in Washington, DC re: the approval of the smith & Nephew BHR. I suggested he draw his own conclusions as to the farse behind this device, that has now proven to hve caused serious injury to folks and in some instances taken their quality of lives away completely.
I explained to him that a pma approved device leaves little legal recourse to those folks that have been affected by the malfuntion of this metal on metal device.
The pma porivides protection for the device manufacturer and deals with the human factor as non existent.
Time will change this. Hopefully sooner than later so that folks impacted by such a
pma device may receive help now and prevent additional damages, like pain, suffering, loss of walking, unable to work etc. etc. etc .etc.
Pingback: Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process « Earl's View