"The Silver Sheet" :: Elsevier Business Intelligence

FDA Close-Out Letters

Thu, 13 Jun 2013 10:30:00 -0400

Seven letters released by FDA from May 14 through June 10.

News In Brief

Thu, 13 Jun 2013 10:30:00 -0400

FDA’s draft guidance distinguishing recalls from product enhancements gets chilly reception from industry; “consumer-friendly” MedWatch form released; and more.

FDA Warning Letters

Thu, 13 Jun 2013 10:30:00 -0400

Design control and MDR procedures lacking at Edwards Lifesciences; CooperSurgical in the hot seat for inadequate complaint handling activities. Eighteen warning letters listed by FDA from May 14 through June 10.

FDA Investigators Talk Quality Issues And Inspectional ‘Games’ Manufacturers Play

sm.schmitt@elsevier.com — Thu, 13 Jun 2013 10:30:00 -0400

There are plenty of typical mistakes that FDA investigators find when inspecting device firms, from failing to adequately document complaints and ensuring proper process validation, to developing ambiguous design inputs during design control activities. Yet what really grates investigators’ nerves is when they have to ask manufacturers several times for procedures and processes that are routinely asked for during an inspection. “Let’s get beyond the things that you know are going to be needed and have them readily available,” says Phil Pontikos, an agency investigator and FDA’s national device...

FDA’s ISO Audit Program Chugs Along; May Be Absorbed By IMDRF Single-Audit Initiative

sm.schmitt@elsevier.com — Thu, 13 Jun 2013 10:30:00 -0400

Thirty manufacturers have used FDA’s ISO 13485 voluntary audit program since the two-year pilot began last June, freeing up scarce agency inspectional resources to be used elsewhere. However, it will likely be eventually absorbed by a pilot Medical Device Single Audit Program currently under development by the International Medical Device Regulators Forum.

FDA’s Latest Post-Market Plan: Data-Mining Device Safety … And Then There’s MAUDE

Wed, 15 May 2013 09:00:00 -0400

Data-mining software tools will be used by FDA to find troubling patterns with particular devices as part of the agency’s latest plan to beef up its post-market surveillance activities. However, “we haven’t determined the device areas in which we will implement data-mining,” CDRH Chief Scientist William Maisel said.

Inside ‘Case For Quality’ Forum: FDA Ponders ‘Critical-To-Quality’ Inspectional Approach

sm.schmitt@elsevier.com — Wed, 15 May 2013 09:00:00 -0400

FDA is considering focusing inspections on ‘critical-to-quality’ practices as part of its ‘Case for Quality’ initiative. A pilot will be launched this year to identify practices related to particular device types or quality system requirements, an agency official says.

FDA Warning Letters

Wed, 15 May 2013 09:00:00 -0400

Care Diagnostica, maker of IVD test kits, cited for QS reg violations; manufacturer of radioactive brachytherapy needle sets failed to investigate complaints. Nine warning letters listed by FDA from April 16 through May 13.

FDA Close-Out Letters

Wed, 15 May 2013 09:00:00 -0400

Five letters released by FDA from April 16 through May 13.

News In Brief

Wed, 15 May 2013 09:00:00 -0400

Firms with an egregious state of quality control might be able to enter into remediation agreements with FDA; agency might ease up on direct marking of devices in final UDI rule; and more.

2-Day Training Workshop | Production and Process Controls: Building a Robust Approach

Wed, 17 Apr 2013 15:56:00 -0400

Join your peers for a two-day, hands-on training workshop, Production and Process Controls: Building a Robust Approach, where you will learn how to implement a system that can withstand a rigorous FDA Inspection or ISO 13485 audit.

News In Brief

Wed, 17 Apr 2013 01:00:00 -0400

Three new IMDRF guidances tackle facility auditing, auditors and UDI; FDA draft home-use guidance in industry’s crosshairs; and more.

Adverse Event Reports Hit All-Time High; FDA Warns Firms About MDRs, Complaint Handling

sm.schmitt@elsevier.com — Wed, 17 Apr 2013 00:00:00 -0400

As FDA sifts through almost a million Medical Device Reports submitted by manufacturers last year, the agency is trying to determine why so many adverse events are being reported. Isaac Chang, a director in CDRH’s Office of Surveillance and Biometrics, speculates that there could be a number of reasons for the large influx of MDRs, including high-profile recalls and a sharper FDA focus on human factors issues.

FDA Warning Letters

Wed, 17 Apr 2013 00:00:00 -0400

Stryker failed to report a recall to FDA in relation to Neptune Rover devices; Integra Neurosciences cited for QS violations. Twenty warning letters listed by FDA from March 12 through April 15.

FDA Close-Out Letters

Wed, 17 Apr 2013 00:00:00 -0400

Close-out letters posted on the agency’s website from March 12 through April 15.

Record Number Of Warning Letters Issued In 2012; Complaint Handling Troubles Significant

sm.schmitt@elsevier.com — Thu, 14 Mar 2013 12:00:00 -0400

Device manufacturers were sent an historic number of warning letters by FDA last year, eclipsing the previous high from 1997. FDA has not yet completed its own analysis of 2012 warning letter trends, but an ex-agency official says there are several likely reasons for the increase.

FDA 2012 Medical Device Quality-Related Warning Letters

Thu, 14 Mar 2013 12:00:00 -0400

Complete list of 103 domestic and 66 foreign device quality-related warning letters released in 2012.

FDA Warning Letters

Thu, 14 Mar 2013 12:00:00 -0400

Cryolife cited for QS violations; Medsys failed to establish MDR procedures. Nine warning letters listed by FDA from Feb. 12 through March 11.

FDA Close-Out Letters

Thu, 14 Mar 2013 12:00:00 -0400

Close-out letters posted on the agency’s website from Feb. 12 through March 11.

News In Brief

Thu, 14 Mar 2013 12:00:00 -0400

FDA draft guidance gives advice to firms for distinguishing recalls from product enhancements; surgeons to be surveyed by agency about da Vinci surgical system; and more.

CDRH Terminating High-Risk Device Recalls Faster As Class I’s Increase In 2012

sm.schmitt@elsevier.com — Wed, 13 Feb 2013 12:00:00 -0500

As the number of class I recalls climbed to a historic high in 2012, CDRH was already taking action to more quickly terminate such high-risk recalls. The device center beefed up its class I recall close-out process by developing a template to standardize terminations and ensure that recalls were appropriately addressed by manufacturers. “What we’re looking to do is to move beyond just removing the recalled device from the shelf,” CDRH official Ann Ferriter said.

2012 Medical Device Recalls