Comment from Stryker Orthopaedic Instruments
AnonymousSupportBusiness
Summary: Stryker Instruments, a medical device company, supports the draft guidance while providing specific technical feedback to ensure clarity and effective implementation. They advocate for the inclusion of certain respirator types (like N99 FFRs) in the scope and suggest modifications to the policy regarding fluid repellency and sterile labeling.
Thank you for the opportunity to comment on this draft guidance. We appreciate FDA’s work in this area and offer the following feedback to support clarity and effective implementation. Detailed comments and recommendations are provided in the attached document.