The Orthopedics Industry “FDA, You Failed Me” by Dr. Robert Christensen
“FDA, You Failed Me” (LinkedIn – Medical Devices Group) Frequent group contributor 89-year-old Dr. Robert Christensen has a story to […]
FDA
FDA floats a proposal for speeding up PMAs
FDA Unveils Plan for Expedited Device Approvals (ODTMag) FDA Draft Guidance Document –> Expedited Access for Premarket Approval Medical Devices Intended for
Showdown – ReGen Biologics appeals the case of the rescinded FDA clearance
ReGen Biologics appeals loss to FDA (MassDevice) ReGen Biologics asks a federal appeals court to overturn its loss of a lawsuit
Major and Sweeping Changes coming to the FDA
MAJOR AND SWEEPING CHANGES PLANNED FOR FDA (Orthopedics This Week) Like the British navy sailing to the Falkland Islands, the Food
FDA upgrades its Medical Device Recalls Database
FDA Announces Improvements To The Medical Device Recalls Database (FDA) Today, the Food and Drug Administration (FDA), Center for Devices and
FDA Panel pushes back on Spherical Devices for interbody spine fusion
Panel highlights lack of support on safety, efficacy of spinal sphere devices for fusion (Healio) In a meeting about the FDA’s
Four Countries to Participate in Pilot Program for Medical Device Audits – US, Canada, Brazil, Australia
Four Countries to Participate in Pilot Program for Medical Device Audits (ODT Magazine) FDA Announcement of MDSAP Pilot Program (FDA) Australia’s Therapeutic
EU says “No” to a proposed FDA-like pre-market approval process
EU Parliament: No PMAs here please The European Parliament today votes not to require medical devices to undergo an approval
EU panel approves FDA-like requirements for medical devices
EU panel approves FDA-like requirements for medical devices (MassDevice) A European Commission panel approves more stringent regulation of medical devices akin
Manufacturers have 1 year to implement a Unique Device Identification system for all Class III devices
AdvaMed Statement on Final Unique Device Identification Rule (AdvaMed) FDA.gov, AdvaMed statement, UDI Resource from FDA Janet Trunzo, senior executive vice president, technology
FDA gives companies new guidance on reporting Adverse Events
ADVERSE EVENT GUIDANCE CHANGES FROM FDA (Orthopedics This Week) The FDA recently issued a 54-page draft guidance to help device manufacturers
Stryker recalls a spine implant, gets ‘Deadly’ FDA Label
Stryker Recalls Spinal Implant, Gets ‘Deadly’ FDA Label (OrthoSpineNews) Stryker (download 4-page analysis of Stryker HERE) is recalling lots of a device used
The FDA’s Medical Device program is broken
FDA’s Device Program Really is in Crisis In July, a subcommittee of FDA’s Science Board released a cleared-eyed 37-page report on what
Integra LifeScience’s TITAN Reverse Shoulder get US approval
INTEGRA’S TITAN (REVERSE SHOULDER) LIFTS OFF (Orthopedics This Week) The folks at Integra LifeSciences Holding Corporation are celebrating. The FDA has
Sequestration will slow down Orthopedic Device approvals
SEQUESTRATION AND DEVICE APPROVALS (Orthopedics This Week) Avoiding “The Sequester” is Washington’s new pork. Medical device companies are going to pay
First Amendment Decision on Off-Label Promotion Will Not Stop FDA
First Amendment Decision on Off-Label Promotion Will Not Stop FDA (EyeforPharma) The recent decision to overturn the conviction of sales rep Alfred
FDA Panel Meeting for SpinalMotion’s metal-on-metal disc is cancelled without explanation
KINEFLEX FDA PANEL MEETING CANCELLED (Orthopedics This Week) SpinalMotion, Inc.’s two-day FDA orthopedic panel meeting scheduled July 24 and 25, 2013
FDA wants to share your company’s clinical data with others
FDA PROPOSES SHARING CLINICAL DATA (Orthopedics This Week) The FDA wants to share your clinical data with “non-FDA experts and other
FDA’s Ortho Panel supports the down-classification of pedicle screws
FDA’s Ortho Panel supports down-classification of pedicle screw spinal systems (MassDevice) The FDA’s Orthopedic & Rehabilitations Devices Panel agrees with the
DEPUY gains PMA clearance of new Ceramic-on-Ceramic total hip system
DEPUY ORTHOPAEDICS, INC. RECEIVES FDA PMA SUPPLEMENT APPROVAL FOR CERAMAX® TOTAL HIP SYSTEM WITH BIOLOX® delta CERAMIC-ON-CERAMIC 36MM LARGE FEMORAL
Stryker escalates ShapeMatch Cutting Guides to Class 1 FDA recall
FDA CLASSIFIES STRYKER SHAPEMATCH RECALL CLASS I (Orthopedics This Week) Stryker Corporation announced on April 10, 2013 that the FDA has
NuVasive gets a warning from the FDA over ILIF labeling
FDA WARNS NUVASIVE OVER ILIF LABELING (Orthopedics This Week) The FDA sent NuVasive, Inc. a warning letter on March 12, 2013
Stryker Orthopedics is working with the FDA with recent recalls
Stryker Orthopedics Under Fire for Marketing (Lawyers and Settlements) Portage, MI: Stryker Orthopedics has come under fire from the US Food and Drug
FDA publishes new Financial Disclosure Guidelines
New Financial Disclosure Guidelines from FDA (Orthopedics This Week) If you own shares in a mutual fund that includes a company
FDA is shortening time to review and clear 510(k)’s
FDA 510(k) Review Times See Improvements (Today’s Medical Developments) Review times for medical device 510(k) premarket notifications by the U.S.
FDA publishes Safety Notice on Metal-on-Metal Hip Implants
FDA Safety Communication: Metal-on-Metal Hip Implants (FDA) Link: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm Date Issued: Jan. 17, 2013 Audience: Orthopaedic surgeons Health care providers responsible for
FDA will insist on a PMA submission for Metal-on-Metal Hips
METAL-ON-METAL HIPS TO REQUIRE PMA (Orthopedics This Week) The FDA has decided that makers of metal-on-metal total hip replacement systems
FDA slaps Zimmer with Class I Recall for Spine device
The FDA slaps Zimmer with Class I status for a global medical device recall of spinal surgery instruments (MassDevice) MASSDEVICE
Off-Label Use and Promotion is protected by Federal Court
Off-Label Use and Promotion Protected by Federal Court (Orthopedics This Week) Federal appeals court panel said on Monday, December 3, that
Two New FDA Rulings Expand Integra’s Product Offerings
Two New FDA Rulings Expand Integra’s Product Offerings (Orthopedics This Week) Earlier this month, the Food and Drug Administration approved an
FDA approves new concentrated platelet rich plasma system by Cytomedix
FDA approves new concentrated platelet rich plasma system (Helio) Cytomedix Inc. received FDA clearance for the use of its Angel Concentrated
NuVasive’s Cervical Disc, the PCM, gains FDA Approval
NuVasive’s Cervical Disc Approved (Orthopedics This Week) The FDA is raining PMAs (Premarket Approval) on the cervical spine industry. NuVasive Inc.’s
China & India Launch New Medical Device Regulations
China & India Launch New Medical Device Regulations (HealthPointCapital) China and India have launched new regulatory guidelines for medical device companies
NLT SPINE get FDA Clearance for eSPIN powered discectomy system
NLT SPINE: 510(k) Clearance for eSPIN (Orthopedics This Week) NLT SPINE is celebrating the announcement that its eSPIN powered discectomy system
FDA imposes new rules when its experts disagree about the science behind a device
New Rules When Scientists Disagree at FDA (Orthopedics This Week) What happens when you go to the FDA with an application
FDA shares 4 strategies on their future post market surveillance system
The FDA has outlined four ways it plans to improve the medical device postmarket surveillance system. The four strategies outlined
FDA asks J&J’s DePuy to recall unused “custom” implants
FDA asks J&J’s DePuy to recall unused custom implants (Mass Device) Johnson & Johnson subsidiary DePuy Orthopedics recalls all unused custom
Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety
Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety (OrthoSpineNews) The Food and Drug Administration (FDA) is often
Total Hip Modular Necks – Is this the next phase of Hip Failures?
Stryker Hip Stem Recall Raises Warnings (Orthopedics This Week) While a blue ribbon FDA panel was wrestling with problems associated with
Stryker voluntarily recalls 2 total hip systems with modular-necks
Stryker Initiates Voluntary Product Recall of Modular-Neck Stems (press release) Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems.
FDA Panel on Metal-on-Metal Hip provides guidance on 8 questions, but no answers to the overall Dilemma
FDA Panel: No Answers to MoM Hip Dilemma (MedPageToday) Two days of public hearings yielded little in the way of solid
This week: FDA Panel Meeting to review Metal-on-Metal Hip Replacements
F.D.A. Hearing to Focus on Replacement Hips (NY Times) The Food and Drug Administration will start a two-day hearing on Wednesday meant to
FDA-CDRH Director Jeff Shuren Touts Improvements in the FDA Process
CDRH’s Shuren Touts Improvements in FDA Process (HealthPointCapital) Copy of Dr Shuren’s slides –> Dr Shuren – Memphis 11June12 In comments
ObamaCares Killer Device Tax
ObamaCare’s Killer Device Tax (WSJ) Much of the political conversation in Washington these days concerns innovation, job creation and competitiveness. But
FDA will consider more rigorous testing for Metal-on-Metal Hip products
FDA Will Review MoM Hip Safety (MedPageToday) FDA seeks more advice on metal hip implants (FDA press release) The FDA “is considering
Spine Startup, Lucero Medical, draws an FDA Warning Letter after inspection
Spinal fusion device draws FDA warning letter (Josh Sandberg) Spinal device company Lucero Medical has received a warning letter from the U.S. Food and Drug
Oops, Global Medical fined $1M by FDA for jumping the gun on Biologics Approval
FDA’s Globus Oops (Walter Eisner @ OTW) Oops. The FDA has changed a statement made in a February 28 press release
FDA threatens Synthes with fines and regulatory action over GMP problems
FDA threatens fines, regulatory action over Synthes’ GMP problems (Fierce Pharma Manufacturing) The international medical device company Synthes has been producing
Synthes gets a warning letter from FDA for poor complaint management
Synthes gets warning letter over complaint management (MedCityNews) Swiss medical device manufacturer Synthes has received a warning letter from U.S.
FDA fines Globus Medical and CEO $1M for selling “rejected” bone graft products
FDA fines Globus Medical and CEO $1M for selling rejected bone graft products (MassDevice) Orthopedics device maker Globus Medical and its