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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
Devicemakers should be prepared to justify their test methodology in 510(k) submissions for highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostics, or HMMDs, newly finalized FDA guidance says. Read More