Devices & Diagnostics Letter

Concerns about the future of the FDA’s 510(k) process appear to have been put to rest with the year-end issuance of a draft guidance on evaluating substantial equivalence in 510(k)s.

Devicemakers responding to unsolicited requests for off-label product information are urged to keep conversations private and specific to the requester’s inquiry, according to a new FDA draft guidance.

A new FDA draft guidance offers specific goals and methods to ensure that more women are represented in medical device clinical trials.

Last year saw few changes in the regulation of devices, but a great deal of debate and planning for upcoming changes.

In response to a citizen petition, the FDA is seeking public input on how it should regulate scientific exchanges on off-label uses for medical products.

A recent FDA warning letter issued to CooperVision in the wake of a massive contact lens recall is not likely to affect the company’s long-term prospects, analysts say.

CDRH supervisors could “telescope” a devicemaker appeal in unusual circumstances by engaging in substantive discussions with individuals higher up in the center’s hierarchy, boosting the dispute to the next-level supervisor, a draft guidance states.

An agreement between a Minnesota medical technology group and CDRH may be the first step toward more state association input on regulatory science.

Poor corrective and preventative action (CAPA) procedures and lack of adverse event reporting garnered a warning letter for Beckman Coulter’s Miami-based cellular analysis business.

FDA efforts to speed issuance of devicemaker warning letters and wrap up more investigations are coming up short, if three recent close-out letters are any indication.

The FDA has announced its tentative 2012 meetings schedule.