"The Silver Sheet" :: Medical Device Quality Control

FDA Close-Out Letters

Thu, 17 May 2012 12:00:00 -0400

Close-out letters posted on the agency’s website from April 10 through May 14.

FDA Warning Letters

Thu, 17 May 2012 12:00:00 -0400

Hill-Rom cited for QS reg violations in relation to AC-powered patient lifts and adjustable hospital beds; maker of infant teething rings did not conduct proper CAPA activities.

Manufacturers Falling Down On Quality Data Collection And Analysis, FDA Warns

sm.schmitt@elsevier.com — Thu, 17 May 2012 12:00:00 -0400

Capturing and analyzing product quality data appears to be a hiccup for many firms, but the problem can be addressed through the use of proper tools and effective monitoring of quality data sources, FDA officials explain. When quality data is added to a manufacturer’s CAPA system and properly analyzed, device problems may be discovered more quickly.

Meridian Bioscience CEO John Kraeutler: How We Turned Around A Deficient Quality System

sm.schmitt@elsevier.com — Thu, 17 May 2012 12:00:00 -0400

Meridian Bioscience’s quality system and company culture needed to change after the firm ran into regulatory trouble between 1999 and 2001, according to CEO John Kraeutler. “What I learned during those two years is, if you tell the FDA you’re going to do something, you really ought to do it,” he said. Meridian feared it was on the precipice of a consent decree with FDA and knew it had to act quickly.

News In Brief

Thu, 17 May 2012 12:00:00 -0400

ISO 13485 will be baseline for IMDRF single-audit work plan; U.S. Marshals seize ultrasound gel made by Pharmaceutical Innovations ISO 13485 will be baseline for IMDRF single-audit work plan.

FDA Looks To New Program To Ease Inspection Burdens For All – But Will Manufacturers Get On Board?

sm.schmitt@elsevier.com — Wed, 11 Apr 2012 12:00:00 -0400

A new voluntary FDA program aims to relieve the inspectional load on manufacturers and the agency. Under the program, firms would submit to FDA a recent ISO 13485 audit report, along with other data, to gain a one-year reprieve from agency inspections.

‘Regulators Forum’ Picks Up Where GHTF Left Off; Plans Include Creation Of Single-Audit Program

sm.schmitt@elsevier.com — Wed, 11 Apr 2012 12:00:00 -0400

The International Medical Device Regulators Forum has identified a single-audit program as a top work item for the new organization. IMDRF is slowly taking over initiatives started by the Global Harmonization Task Force, which will close at the end of the year.

FDA Warning Letters

Wed, 11 Apr 2012 12:00:00 -0400

H&H Wholesale Services cited for QS and MDR reg violations in relation to OneTouch and One Step Test Strips.

FDA Close-Out Letters

Wed, 11 Apr 2012 12:00:00 -0400

Close-out letters posted on the agency’s website from March 13 through April 9.

News In Brief

Wed, 11 Apr 2012 12:00:00 -0400

FDA will specify the types of devices subject to human factors data requirements in an upcoming guidance; researcher calls on FDA to create adverse event system for device interoperability.

Debate Grows Around Timeliness Of FDA Close-Out Letters; Warning Letters Going Out Faster

sm.schmitt@elsevier.com — Wed, 14 Mar 2012 12:00:00 -0400

Writing a thorough warning letter response just might help a manufacturer receive an FDA close-out letter more quickly. A well-crafted response can help the agency decide whether to close out some warning letters without performing a reinspection. “If we can conduct a paper review of a firm that has revamped its MDR [Medical Device Reporting] processes, and we find those MDR processes acceptable based on the paper review, then we may be able to close out the warning letter,” CDRH Office of Compliance Director Steven Silverman said.

FDA 2011 Medical Device Quality-Related Warning Letters

Wed, 14 Mar 2012 12:00:00 -0400

Complete list of 121 device quality-related warning letters released in 2011.

FDA Warning Letters

Wed, 14 Mar 2012 12:00:00 -0400

Thoratec failed to notify FDA in a timely fashion after receiving a complaint that a device may have caused or contributed to a patient death; DePuy Orthopaedics cited for QS reg violations.

FDA Close-Out Letters

Wed, 14 Mar 2012 12:00:00 -0400

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

News In Brief

Wed, 14 Mar 2012 12:00:00 -0400

CDRH plans to propose a new national comprehensive post-market surveillance strategy this spring; FDA to use eSubmitter for recalls.

CDRH And Industry Action Spurs Largest Annual Device Recall Count In FDA History

sm.schmitt@elsevier.com — Wed, 15 Feb 2012 12:00:00 -0500

Device recalls increased 33 percent in 2011 because of FDA’s work to reduce a backlog of unclassified recalls, manufacturer concern about nonconforming products and the agency’s sharp focus on radiological device safety, among other explanations. “The elimination of the recall backlog in ORA and the center, as well as enhanced industry reporting, were big factors across all FDA-regulated products,” said Ann Ferriter, director of the Division of Risk Management Operations in CDRH’s Office of Compliance. And the center is continuing to improve: In the first quarter of FY 2012, it achieved an 80 ...

2011 Medical Device Recalls

Wed, 15 Feb 2012 12:00:00 -0500

Complete table of recalls from calendar year 2011 includes 41 class I (4%), 873 class II (91%) and 43 class III (5%) medical device events.

2011 Class I Recalls

Wed, 15 Feb 2012 12:00:00 -0500

Five firms – Arrow International, Boston Scientific, Fresenius, Maquet and Medtronic – chalked up two apiece in 2011, while a hodgepodge of other manufacturers made up the remainder.

FDA Warning Letters

Wed, 15 Feb 2012 12:00:00 -0500

Integra LifeSciences cited for problems with mold at one of its manufacturing facilities.

News In Brief

Wed, 15 Feb 2012 12:00:00 -0500

Senators want to know why it’s taking so long for the Office of Management and Budget to release FDA’s proposed UDI rule; CDRH’s 2013 budget increase would come from industry.

CDRH Following Up More Actively On Complaints Against Device Manufacturers

sm.schmitt@elsevier.com — Wed, 11 Jan 2012 12:00:00 -0500

FDA’s device center is using a new system to triage complaints filed against companies, with the aim of focusing on those representing the highest risk to patient safety. The system, put into use in December, “helps us eliminate complaints that are not significant enough to take action on and it helps us be more consistent with the handling of complaints,” said Ann Ferriter, director for the Division of Risk Management Operations in CDRH’s Office of Compliance.

FDA District Offices Expect Specific Information From Firms When Recalls Are Initiated

sm.schmitt@elsevier.com — Wed, 11 Jan 2012 12:00:00 -0500

Before initiating a recall, firms should first contact an FDA district office so it can review recall communications and strategies. “The district office may look at your recall strategy and find that somehow it’s inadequate, so the agency may push for you to amend it,” said Cecilia Wolyniak, an FDA recall team leader. Officials explain the types of information that should be sent to district offices.

Editor’s Picks – Three Notable ‘Silver Sheet’ Stories From 2011

Wed, 11 Jan 2012 12:00:00 -0500

Top stories of 2011. “Silver Sheet” readers were most interested in recalls, an FDA plan to boost device quality and process validation tips.

FDA Warning Letters

Wed, 11 Jan 2012 12:00:00 -0500

QS and MDR reg violations identified at manufacturer of LED surgical lamps; CooperVision cited for problems with contact lens labeling.

FDA Close-Out Letters

Wed, 11 Jan 2012 12:00:00 -0500

Close-out letters released by the agency from Dec. 13 through Jan. 9.

News In Brief

Wed, 11 Jan 2012 12:00:00 -0500

FDA orders makers of surgical mesh and mini-slings to conduct Sec. 522 post-market studies; agency aims to make guidance development process more transparent.

Mending A Poor Reputation With FDA An Uphill Battle For Firms – But It Can Be Done

sm.schmitt@elsevier.com — Wed, 14 Dec 2011 12:00:00 -0500

Manufacturers can develop a bad reputation with FDA for a variety of reasons, including failing to systemically fix problems or follow through on commitments. “It’s tiresome, frankly, as a regulator, to have firms come in and pay lip service to the steps that they’re going to take, and then not follow up to demonstrate that they’ve taken those steps,” said CDRH Office of Compliance Director Steven Silverman. In addition, two former agency officials explain why FDA doesn’t trust some companies. “As promises that are made to the agency are broken, or when there is a failure to seriously strive t...

FDA Warning Letters

Wed, 14 Dec 2011 12:00:00 -0500

Beckman Coulter cited for QS and MDR reg violations in relation to its in vitro diagnostic devices; another LASIK user facility cited for MDR problems.

FDA Close-Out Letters

Wed, 14 Dec 2011 12:00:00 -0500

Close-out letters released by the agency from Nov. 11 through Dec. 12.

News In Brief

Wed, 14 Dec 2011 12:00:00 -0500

Three former Synthes executives sentenced to prison time for shipping adulterated devices to market; FDA pushes Invacare to sign consent decree.

Three Barriers To Device Quality And What FDA, Industry Might Do About Them

sm.schmitt@elsevier.com — Fri, 11 Nov 2011 00:00:00 -0500

FDA is reassessing its facility inspection strategy after hearing that industry believes the agency places manufacturer adherence to the Quality System Regulation ahead of product quality. Manufacturers’ perceptions that they must throw an exorbitant amount of resources at low-risk problems found during agency inspections is just one of three roadblocks to quality outlined in “Understanding Barriers to Medical Device Quality,” an FDA report released Oct. 31.

FDA Report Singles Out 7 Areas Where Manufacturers Can Boost Quality

Fri, 11 Nov 2011 00:00:00 -0500

FDA’s Oct. 31 report, “Understanding Barriers to Medical Device Quality,” identifies seven areas where manufacturers struggle to achieve product quality. It also suggests some best industry practices.

FDA Warning Letters

Fri, 11 Nov 2011 00:00:00 -0500

The following chart lists medical device-related warning letters released by FDA from Oct. 11 through Nov. 10. If an inspection led to the warning letter, the location of the inspected facility and dates of inspection are noted; otherwise, the location of the warning letter recipient is listed.

Recent FDA Close-Out Letters

Fri, 11 Nov 2011 00:00:00 -0500

FDA’s close-out program publicly indicates when a manufacturer has addressed agency concerns outlined in a warning letter. The agency sends a close-out letter to the company and posts the letter on its website.

NEWS IN BRIEF

Fri, 11 Nov 2011 00:00:00 -0500

Former CDRH officials join firms Tim Ulatowski, former director of CDRH’s Office of Compliance, has joined Becker Consulting as director of the firm’s expert advisory committee on medical devices. Ulatowski retired from FDA in January; he was replaced by Steven Silverman.

Class I Device Recalls Would Prompt Inspections Under Potential FDA Plan

sm.schmitt@elsevier.com — Sat, 01 Oct 2011 12:00:06 -0400

A high-risk product recall would automatically trigger an FDA facility inspection under a new plan being considered by device center officials.

FDA Officials Describe Common Quality System Training Mistakes

sm.schmitt@elsevier.com — Sat, 01 Oct 2011 12:00:05 -0400

Properly trained employees are a manufacturer’s first line of defense to ensure that only high-quality devices make their way to market.

Top Management’s Job: Allocate Resources To Ensure Employees Are Trained

Sat, 01 Oct 2011 12:00:04 -0400

A device firm’s top management does not need to be trained to the same degree as others in the organization, FDA says.

FDA Warning Letters

Sat, 01 Oct 2011 12:00:03 -0400

The following chart lists medical device-related warning letters released by FDA from Sept. 13 through Oct. 10. If an inspection led to the warning letter, the location of the inspected facility and dates of inspection are noted; otherwise, the location of the warning letter recipient is listed.

Recent FDA Close-Out Letters

Sat, 01 Oct 2011 12:00:02 -0400

NEWS IN BRIEF

Sat, 01 Oct 2011 12:00:01 -0400

GHTF issues new UDI guidance

FDA: Make Sure Process Validation Is Conducted By ‘Qualified’ Personnel

sm.schmitt@elsevier.com — Thu, 01 Sep 2011 12:00:06 -0400

Employees who carry out process validation activities at device firms must be trained to a greater degree than others at the company, FDA says.

The Tricky Business Of Environmental Control

sm.schmitt@elsevier.com — Thu, 01 Sep 2011 12:00:05 -0400

FDA reminds device companies that they must control environmental conditions for both products and manufacturing facilities, or risk potentially tough regulatory penalties.

Environmental Control Blunders

Thu, 01 Sep 2011 12:00:04 -0400

Ensuring proper environmental control can indeed prove tricky for some manufacturers. Here are three examples that show how a lack of proper control can cause problems for firms:

FDA Warning Letters

Thu, 01 Sep 2011 12:00:03 -0400

The following chart lists medical device-related warning letters released by FDA from Aug. 9 through Sept. 12. If an inspection led to the warning letter, the location of the inspected facility and dates of inspection are noted; otherwise, the location of the warning letter recipient is listed.

Recent FDA Close-Out Letters

Thu, 01 Sep 2011 12:00:02 -0400

NEWS IN BRIEF

Thu, 01 Sep 2011 12:00:01 -0400

Staff changes at device center

First-Rate Procedures Key To Good Internal Quality Audits, FDA Advises

sm.schmitt@elsevier.com — Mon, 01 Aug 2011 12:00:04 -0400

Conducting robust internal quality audits is an important way for device manufacturers to ensure they fully comply with FDA regulations, agency officials say, but good auditing can’t happen without appropriate procedures.

FDA Warning Letters

Mon, 01 Aug 2011 12:00:03 -0400

The following chart lists medical device-related warning letters released by FDA from July 15 through Aug. 8. If an inspection led to the warning letter, the location of the inspected facility and dates of inspection are noted; otherwise, the location of the warning letter recipient is listed.

Recent FDA Close-Out Letters

Mon, 01 Aug 2011 12:00:02 -0400