federal_register: 02-31991
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 02-31991 | Medical Devices; Designation of Special Control for Eight Surgical Suture Devices | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend the classification regulations for eight surgical suture devices previously reclassified into class II, in order to specify a special control for those devices. FDA is proposing the guidance document "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" as the special control that the agency believes will reasonably assure the safety and effectiveness of the devices, and FDA is announcing the availability for comment of that guidance document elsewhere in this issue of the Federal Register. Elsewhere in this issue of the Federal Register, FDA is also publishing a final rule reclassifying the absorbable polydioxanone surgical (PDS) suture from class III (premarket approval) to class II (special controls), and is designating as the special control for that device, effective immediately, the same guidance document here proposed as the special control for the eight surgical sutures devices covered by this proposed rule. After public comments are reviewed, FDA intends to issue a final rule for the eight surgical sutures covered by this proposed rule, making the guidance effective as the special control guidance for those sutures in addition to the PDS suture. Following the effective date of such final rule, any firm submitting a premarket notification (510(k)) for a new surgical suture will need to address the issues covered in the special control guidance. However, the firm needs only to show that its device meets the recommendations of the guidance or in some other way provides equivalent assurance of safety and effectiveness. | 2002-12-19 | 2002 | 12 | https://www.federalregister.gov/documents/2002/12/19/02-31991/medical-devices-designation-of-special-control-for-eight-surgical-suture-devices | https://www.govinfo.gov/content/pkg/FR-2002-12-19/pdf/02-31991.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to amend the classification regulations for eight surgical suture devices previously reclassified into class II, in order to specify a special control for those devices. FDA is proposing the guidance... |