Coated combination products: Regulation and technology

Medical Device and Diagnostic Industry

Volumn , Issue MAR., 2005, Pages 23-30

  Triolo, Phil ^a  

^a Phil Triolo and Associates LC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 27844497499     PISSN: 0194844X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (20)

1. Phil Triolo, "Using Risk Analysis to Develop Coated Medical Devices," Medical Device & Diagnostic Industry 27, no. 1 (2005): 130-140.
2. Code of Federal Regulations, 21 CFR 3, Docket No. 2004N-0194, Federal Register, vol. 69, no. 89 [on-line] (Rockville, MD: FDA, 2004); available from Internet: www.fda.gov/OHRMS/DOCKETS/9Sfr/oc03366.pdf.
3. Code of Federal Regulations, 21 CFR 3.7.
4. Guideline for Drug Master Files [on-line] (Rockville, MD: FDA, CDRH, 1989); available from Internet: www.fda.gov/cder/guidance/dmf.htm.
5. Draft Guidance: Drug Product Chemistry, Manufacturing, and Controls Information [on-line] (Rockville, MD: FDA, CDER, 2003); available from Internet: www.fda.gov/cder/guidance/1215dft.pdf.
6. Draft Guidance: Drug Substance Chemistry, Manufacturing, and Controls Information [on-line] (Rockville, MD: FDA, CDER, 2004); available from Internet: www.fda.gov/cder/guidance/3969DFT.doc.
7. Draft Guidance Document for Testing Biodegradable Polymer Implant Devices [on-line] (Rockville, MD: FDA, CDRH, 1996); available from Internet: www.fda.gov/cdrh/ode/odegr914.html.
8. ISO 10993-1, "Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing" (Geneva: International Organization for Standardization, 2003).
9. Guidance for Industry: Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products [on-line] (Rockville, MD: FDA, CDER, 2003); available from Internet: www.fda.gov/cder/guidance/4985fnl.pdf.
10. Draft Guidance: Stability Testing of Drug Substances and Drug Products [on-line] (Rockville, MD: FDA, CDER, 1998); available from Internet: www.fda.gov/cder/guidance/1707dft.pdf.
11. Draft Guidance: Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation [on-line] (Rockville, MD: FDA, CDER, 2000); available from Internet: www.fda.gov/cder/guidance/2396dft.htm.
12. IDE Guidance Memorandum D95-1, Goals and Initiatives for the IDE Program [on-line] (Rockville, MD: FDA, CDRH, 1995); available from Internet: www.fda.gov/cdrh/d951.html.
13. IDE Guidance Memorandum D99-1, Pre-IDE Program: Issues and Answers [on-line] (Rockville, MD: FDA, CDRH, 1999); available from Internet: www.fda.gov/cdrh/ode/d99-1.html.
14. Boam, Ashley, "Drug-Eluting Stents: Current Approach to Review" (presented at Workshop on Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges, July 8, 2003).
15. Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Premarket Approval [on-line] (Rockville, MD: FDA: Office of Regulatory Affairs, 1993); available from Internet: www.fda.gov/ora/compliance_r.ef/cpg/cpgdrg7cpg490-100.html.
16. Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff [on-line] (Rockville, MD: FDA, CDRH, 2003): available from Internet: www.fda.gov/cdrh/comp/guidance/1140.html.
17. Adverse Event Reporting System (AERS) [on-line] (Rockville, MD: FDA, CDER, 2002); available from Internet: www.fda.gov/cder/aers/default.htm.
18. Medical Device Reporting (MDR) [on-line] (Rockville, MD: FDA, CDRH, 2002); available from Internet: www.fda.gov/cdrh/mdr.
19. Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters [on-line] (Rockville, MD: FDA, CDRH, 1995); available from Internet: www.fda.gov/cdrh/ode/824.pdf.
20. Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters [on-line] (Rockville, MD: FDA, CDRH, 1997); available from Internet: www.fda.gov/cdrh/ode/oderp097.html.