* In general, clinical studies will not be needed for most surgical suture devices, FDA may recommend that you collect clinical data for a surgical suture device with:
- a formulation dissimilar from formulations previously cleared under a 510(k);
- a new technology, i.e., technology different from that used in legally marketed surgical suture devices; or
- indications for use dissimilar from indications for use of sutures of the same type.
FDA will always consider alternatives to clinical testing when the proposed alternatives are supported by an adequate scientific rationale.
This guidance document was published on December 19, 2002, in conjunction with a Federal Register notice announcing the reclassification of the absorbable PDS suture. This 2003 guidance document supplements the December 19, 2002 “Class II Special Controls Guidance Document for 510k: Surgical Sutures; Guidance for Industry and FDA.” The FDA thinks that specific controls, in conjunction with general controls, will offer reasonable assurance of the safety and efficacy of these surgical suture devices.
Why Choose I3CGLOBAL for Surgical Sutures 510(k) Submission?
85% Success Rate, 180 Plus 510(k) Clearance, 112 Plus manufactures, Serving manufacturers and specification developers from 1999, We are one among the best, largest and most economic regulatory compliance solution provider for medical device 510(k) premarket notification.
We are available 24x7 for you!
We provide best technical and scientific support and service for surgical sutures 510k preparation and submission across the globe. We solve every obstacle in the path of Class I, II, and III Medical Device FDA 510(k) Premarket Notification.