Medical Device Safety and Recalls: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication

Medical Device Safety and Recalls: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication Today, the FDA issued the Safety Communication, “FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods to notify health care professionals about our concerns with theContinue reading “Medical Device Safety and Recalls: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication”

Medical Device Single Audit Program (MDSAP) Mid-Pilot Status

The FDA just released the Mid-Pilot Report for the Medical Device Single Audit Program (MDSAP), to provide the current status of the program’s performance goal and objectives. The goal of the MDSAP pilot is to provide objective evidence that a regulatory audit of a medical device manufacturer conducted by an MDSAP-recognized auditing organization can fulfillContinue reading “Medical Device Single Audit Program (MDSAP) Mid-Pilot Status”

Medical Device Safety and Recalls: Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs

Today the FDA issued a safety communication regarding serious adverse events with Implantable Left Ventricular Assist Devices (LVADs). To date, there are two implantable LVADs approved by the FDA: The HeartMate II Left Ventricular Assist System manufactured by Thoratec Corporation, and the HeartWare Ventricular Assist System HVAD manufactured by HeartWare, Inc. The FDA is aware ofContinue reading “Medical Device Safety and Recalls: Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs”

Medical Device Safety and Recalls: MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254

Medical Device Safety and Recalls: MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 A recall has been issued for MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 . MicroPort Orthopedics Inc. has received reports of an unexpected rate of fractures after surgery related to thisContinue reading “Medical Device Safety and Recalls: MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254”

CDISC Will Be Required by Kit Howard

Over the past decade or so, a tremendous amount of development work has gone into creating standards for data to be submitted electronically to the FDA. There are those, however, who question whether these standards will ever be required, and believe that unless the FDA requires them, the standards don’t have to be adopted. Indeed,Continue reading “CDISC Will Be Required by Kit Howard”

Overview of the 510(k) medical device approval process in the USA

FAIR USE- “Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor ofContinue reading “Overview of the 510(k) medical device approval process in the USA”