FDA head Gottlieb updates on new recall info policies

January 19, 2018 By Fink Densford Leave a Comment

FDA head Dr. Scott Gottlieb yesterday announced new steps the agency is taking to improve the posting of recall notices, including earlier posting of yet-to-be classified recalls and earlier summaries of corrective actions.

The notice comes a month after Dr. Gottlieb went on the record saying the agency was committed to improving its recall processes.

The federal watchdog released new draft guidance laying out its policies on public warnings and notifications of recalled products, including specific guidelines for when and how to issue such warnings and the conditions necessary for the agency to step in during a recall process.

“The draft guidance is a key step to enhance the recall process. It gives industry clear direction on how to navigate and work with the FDA to make sure that recalls are communicated promptly. Ultimately, it will better empower consumers by providing more timely and more accurate information on recalled products,” Gottlieb said in an FDA press release.

In the update, the FDA said it will begin to post recall warnings to its Enforcement Report site even before recalls have been classified as Class I, II or III.

Dr. Gottlieb said that the FDA would continue to develop new policy on what information it will publicize, with a specific focus on the release of detailed data on recalled foods.

The FDA said the guidance was only the first in a series it expects to release this year to improve safety and how it implements recalls.

“We all know that hazardous recalled products can have a devastating impact on human lives. We’re committed to making sure that recalls are initiated, overseen, and completed promptly and effectively to best protect consumers; and we will use all the tools at our disposal to carry through on this commitment,” Dr. Gottlieb said in a prepared statement.

Registration is Open for DeviceTalks Boston

Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.

REGISTER NOW

Medical device cybersecurity: It’s time to get real
Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen cybersecurity. But are they doing enough? Almost no one in the medtech industry disputes the vulnerability posed by cyberattacks. How to go about boosting security is another matter – one on which those stakeholders have recently stepped up their collaboration. One… […]
Can a lifetime guarantee boost value-based care?
Swiss orthopedics company Medacta International and Geisinger Health System have said they will pilot a lifetime guarantee program for knee replacement surgeries. The program will cover full costs for screened Geisinger Health Plan members who receive knee replacement surgery while also ensuring reimbursement for any associated future care the patients may incur throughout their lifetimes.… […]
Compounding Solutions launches new tie-layer resin
Compounding Solutions (Lewiston, Maine) recently announced that it has launched a new tie-layer resin for the medical device industry. ReZilok Rx is meant for the manufacturing of multilayer co-extruded medical films and catheter tubing, the company said in a February announcement. Compounding Solutions’ R&D team developed ReZilok Rx as a linear low-density polyethylene grafted with… […]
GI Dynamics touts results of U.K. study
GI Dynamics (ASX:GID) said a retrospective study of its EndoBarrier device for patients with type 2 diabetes and obesity shows a significant reduction in HbA1c, weight, liver fat and cardiovascular disease (CVD) risks as well as a reduction in the need for insulin in some patients. The EndoBarrier device is a plastic gut sleeve designed… […]
Think Surgical, United Orthopedic join forces for global sales
Think Surgical and United Orthopedic have announced a global joint marketing agreement of Think’s Active robotic system and United’s U2 knee system. Think’s Active robotic system consists of a 3D pre-surgical planning workstation and its computer-assisted Active robot. Its use in total knee arthroplasty is the subject of an FDA investigational device exemption study, with… […]
FDA ramps up scrutiny of materials in medical devices
The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts… […]
AxioMed receives CE Mark approval for Cervical Freedom
AxioMed has received CE Mark approval for its viscoelastic disc replacement device. The Cervical Freedom’s total disc replacement is now eligible for commercialization in the European, Asian, Latin American and Australian markets and where it has already been TGA approved. AxioMed’s Freedom Cervical disc responds to loading and moves in three dimensions like the human… […]
10 orthopedic products from AAOS 2019 you need to know
The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas is abuzz about robotics, according to industry analysts from SVB Leerink. While the SVB Leerink analysts termed Stryker’s (NYSE:SYK) Mako platform “best-in-class,” robotically assisted orthopedic surgery is an expanding category. Other major orthopedics companies are using this week’s AAOS meeting to introduce new… […]
Webinar: Here’s how you create better healthcare experiences through human-centered design
Wednesday, April 17, 2019 2 p.m. Eastern time / 11 a.m. Pacific time The greatest challenges in healthcare are at the human level. Diet, fitness, medication adherence and regular check-ups can all be influenced by our personal relationships. While today’s technology can impede these human-to-human interactions, following a human-centered approach gives organizations the power to… […]
Orthopaedic Implant Co. enters sports medicine market with new suture anchor
The Orthopaedic Implant Company (“OIC”) said it has launched a 5.5mm PEEK suture anchor system for orthopedic surgery. The OIC 5.5mm suture anchor accommodates up to three #2 sutures of any brand, resulting in an implant that offers flexibility, at a cost-effective price, according to the Reno, Nev.-based company. The anchors are made of biocompatible… […]
Oberd launches AI-assisted tech for gathering outcome data
Patient-reported outcomes vendor Oberd said it has launched software designed to reduce a patient’s time in completing outcomes surveys for orthopedic procedures. Patient-reported outcomes can help quantify the value of a healthcare provider’s services. Columbia, Mo.-based Oberd’s computer-adaptive test (CAT) software has been developed and validated for all of the outcomes surveys approved by the… […]