Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5705209 | Ophthalmology | 2017 | 10 Pages |
Abstract
Most ophthalmic devices approved via the FDA's PMA pathway have undergone extensive revisions, including serial design and labeling changes, since their initial approvals, often without supporting clinical data. Ophthalmologists should take into consideration that cumulative revisions may render the clinical evidence that supported an original FDA approval less relevant to newer device models.
Keywords
Related Topics
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Medicine and Dentistry
Ophthalmology
Authors
Anand D. BA, BS, Vinay K. MD, Christopher C. MD, Lucian MD, PhD, Joseph S. MD, MHS,