BioStructures Cited for Marketing Unapproved Uses for Bone Filler

When an FDA investigator wrapped up a May inspection of BioStructures, company officials felt pretty confident — there was no Form 483 and they had a productive discussion with the inspector. But last month, the company got what CEO Russell Cook is calling an “October surprise” — a warning letter telling BioStructures it must submit a PMA for its bone void filler. The letter is unclear about why the PMA is needed. First, it implies the device has not been cleared or approved. But then it suggests the PMA is needed for new uses. “It’s baffling,” Cook said.
Devices & Diagnostics