A Thursday draft guidance from CDRH attempts to clarify the distinction between hearing aids and personal sound amplification products, or PSAPs. Read More

CDRH plans to roll out 12 final guidance documents in fiscal 2014, including guidances on cybersecurity, the device appeals process and the global unique device identification database, or GUDID, the center revealed Thursday. Read More

San Luis Obispo, Calif.-based FzioMed said the FDA has agreed to hear its appeal on a decision not to approve the company’s Oxiplex Gel spinal product, a clear, absorbable gel applied during lumbar spine surgery. Read More

HeartWare International plans to present data from the Endurance destination therapy trial of its ventricular assist device in early 2015 and could file a PMA sometime before that, CEO Doug Godshall said on a Thursday third-quarter earnings call. Read More

The FDA’s Ear, Nose and Throat Devices Panel voted Friday to recommend approval of a first-of-its kind cochlear implant that does not destroy a patient’s residual hearing. Read More

The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet its own specification for mechanical testing. Read More

St. Petersburg, Fla.-based Lenstec fielded an FDA Form 483 after “canceling” 15 complaints attributed to user error, rather than closing them. Read More

Bausch + Lomb Surgical was handed a Form 483 for issues related to its CAPA procedures and control of nonconforming product. Read More

Retractable Technologies’ device history records do not include a cycle chart for part of the sterilization cycle used by one of the company’s contract sterilizers for 1cc and 3cc VanishPoint syringe product lines, according to a recent Form 483. Read More

The International Medical Device Regulators Forum will launch its medical device single audit program (MDSAP) pilot in January in the U.S., Canada, Australia and Brazil. Read More

Medtronic was slapped with a 15-citation warning letter following a preapproval inspection for its MiniMed 530G continuous glucose monitoring system. Read More

FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Read More