The GMP Letter

Safety and industry experts are questioning a study that claims the device regulatory system in Europe is as safe as in the U.S., despite the EU’s reputation for putting devices in the market faster.

Boston Scientific and its subsidiary, Guidant, are facing a new lawsuit relating to Guidant’s handling of defective implantable cardioverter defibrillators (ICDs) earlier this decade after settling a related suit last month for almost $300 million.

To address several issues on a Form 483, Peregrine Surgical stopped distributing its adjustable laser probe and voluntarily recalled the product, but the FDA says that’s not enough.

A long-standing warning letter that has held up FDA approval of several Medtronic cardiac devices may be closed soon.

The FDA’s Denver district office gave ASI Medical a Form 483 after finding it had not implemented its standard operating procedure (SOP) for documenting the evaluation and approval of vendors and establishing an approved vendor list.

Spectranetics has received a Form 483 with several complaint- and medical device reporting (MDR)-related observations.

New Leaf Medical has received a Form 483 with several repeat observations related to documentation.

Syneron has received an FDA warning letter for GMP violations regarding its skin-tightening device, which it sold without clearance or premarket approval.

The impact of a global diagnostic isotope shortage last year is still reverberating throughout the device industry as healthcare providers continue to use the alternative imaging methods they were forced to adopt to deal with the prolonged technetium-99m (Tc-99m) shortage.

Devicemakers nervous about seeing their executives targeted for criminal prosecution under the FDA’s stepped-up enforcement campaign based on the Park doctrine have received some insight into the factors the agency considers when pursuing such cases.

While devicemakers are rushing to meet the demand for wireless medical technology and smartphone applications, the Federal Communications Commission (FCC) is looking for ways to stretch the nation’s limited spectrum that makes those devices work.

Quality control issues involving Smith & Nephew’s ceramic acetabular hip implants have resulted in a warning letter.

Verichem Laboratories has received a warning letter for failing to validate the design of some of its diagnostic kits under defined operating conditions.

Failure to notify the FDA of field corrections and complaint-handling issues has resulted in a warning letter to Tosoh Biosciences.

Industry may see an end to indefinite waits for major guidances as the FDA could develop timelines for producing the documents.