Devices

Multiple Violations in Repro-Med Systems Inspection

A 6/3-6/23/15 FDA inspection at Repro-Med Systems, Chester, NY found multiple violations in the firm’s work as a specification developer and manufacturer of infusion pumps and intravascular administration sets, according to a 2/26 Warning Letter from the agency’s New York District Office. Specific violations noted on an FDA-483 included:
the company’s Class 3 infusion pumps do not have an approved PMA or IND in effect; the company did not notify FDA of its intent to introduce the infusion pumps into commercial distribution; the Freedom 60 Syringe Infusion Pump that has a 510(k) clearance was modified in a manner that could significantly affect safety and effectiveness; the firm is promoting the Freedom 60 for indications that would constitute a major change or modification to the device’s intended use, for which it lacks clearance or approval; the RMS High-Flo subcutaneous safety needle set is a Class 3 device that does not have an approved application for PMA or IND in effect; the company did not notify FDA of its intent to introduce the needle set into commercial distribution; the company is promoting the needle set for an indication outside the cleared intended use; failing to complete design verification activities to confirm that the design output meets the design input requirements; failing to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation; failing to establish procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained; failing to establish and maintain procedures for rework, including retesting and revaluation of nonconforming product after rework, to ensure that the product meets the current approved specifications; failing to establish and maintain procedures for implementing corrective and preventive action; failing to establish and maintain procedures for acceptance activities; and failing to furnish material or information required under Medical Device Reporting regulations.

The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome