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When preparing 510(k) submissions, devicemakers should never forget that the “devil is in the details,” a regulatory adviser says. Companies would do well to have a second set of eyes review the submission after any work or changes to guard against mistakes. Read More
Citing industry concerns, the FDA has reversed plans for a proposed voluntary presubmission process that would have allowed sponsors to get reviewer feedback before submitting an investigational device exemption application. Read More
Devicemakers are asking the FDA to retain the current classification scheme for Class III devices, saying a proposal to establish risk-based categories would require PMAs for many more devices than currently undergo full premarket approval. Read More
The number of 510(k) submissions found not substantially equivalent could rise following recent FDA guidance blocking the use of split predicates and establishing expectations for benefit-risk determinations, say legal experts. Read More