| Draft
Guidance for Industry on Electronic Records; Electronic Signatures,
Electronic Copies of Electronic Records (.pdf) |
November 12,
2002
|
| Class
II Special Controls Guidance Document: Intraoral Devices for Snoring
and/or Obstructive Sleep Apnea; Guidance for Industry and FDA |
November 8,
2002
|
| Class
II Special Controls Guidance Document: Transcutaneous Air Conduction
Hearing Aid System (TACHAS); Guidance for Industry and FDA |
November 6,
2002
|
| Class
II Special Controls Guidance Document: Human Dura Mater; Draft Guidance
for Industry and FDA |
October 22,
2002
|
| The
Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept
and Principles; Final Guidance for FDA and Industry |
October 4,
2002
|
| Class
II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays;
Guidance for Industry and FDA (.pdf file) |
September 16,
2002
|
| Draft
Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from
Bioengineered Plants for Use in Humans and Animals |
September 12,
2002
|
| Regulatory
Status of Disinfectants Used to Process Dialysate Delivery Systems and
Water Purification Systems for Hemodialysis; Guidance for Industry and FDA |
September 9,
2002
|
| Related
Document: Medical Devices Made With Polyvinylchloride (PVC) Using the
Plasticizer di-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry
and FDA |
September 6,
2002
|
| Updated
510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA |
September 5,
2002
|
| Class
II Special Controls Guidance Document: Dental Sonography and Jaw Tracking
Devices; Draft Guidance for Industry and FDA Reviewers
(PDF document) |
August 14,
2002
|
| Guidance
for Industry: FDA Export Certificates |
August 12,
2002
|
| Frequently
Asked Questions on the Recognition of Consensus Standards; Guidance for
Industry and for |
July 30,
2002
|
| Guidance
on the Department of Defense Exemption from the FDA Performance Standard
for Laser Products; Guidance for Industry and FDA |
July 18,
2002
|
| Class
II Special Controls Guidance Document: Root-form Endosseous Dental
Implants and Abutments; Draft Guidance for Industry and FDA |
May 14, 2002
|
| Class
II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained
Cemented or Uncemented Prosthesis |
April 30,
2002
|
| Medical
Devices: Class II Special Controls Guidance Document: Endolymphatic Shunt
Tube With Valve; Final Guidance for Industry Availability |
April 29,
2002
|
| Related
Document: Class II Special Controls Guidance Document: Endolymphatic Shunt
Tube With Valve; Final Guidance for Industry |
April 29,
2002
|
| MQSA
Final Regulations: Modifications and Additions to Policy Guidance Help
System #4; Guidance for Industry and FDA |
April 2,
2002
|
| Draft
Guidance for Industry on Electronic Records; Electronic Signatures, Time
Stamps
(pdf format) |
March 20,
2002
|
| Premarket
Notification [510(k)] Submissions for Medical Sterilization Packaging
Systems in Health Care Facilities; Draft Guidance for Industry and FDA |
|
| Class
II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays;
Draft Guidance for Industry and FDA |
February 21,
2002
|
| Class
II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2)
and Oxygen (PcO2) Monitors; Draft Guidance for Industry and FDA |
February 12,
2002
|
| Class
II Special Controls Guidance Document: Medical Washers and Medical
Washer-Disinfectors; Guidance for the Medial Device Industry and FDA
Review Staff |
February 7,
2002
|
| Class
II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void
Filler Device; Draft Guidance for Industry and FDA |
February 7,
2002
|
| Draft
Guidance: Disclosure of Conflicts of Interest for Special Government
Employees Participating in FDA Product Specific Advisory Committees |
February 1,
2002
|
| Medical
Devices; Gastroenterology-Urology Devices; Classification of the
Ingestible Telemetric Gastrointestinal Capsule Imaging System |
January 24,
2002
|
| Medical
Devices; Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications |
January 15,
2002
|
| Sterilized
Convenience Kits for Clinical and Surgical Use; Final Guidance for
Industry |
January 11,
2002
|
|
|
