One of the responsibilities of the Office of Device Evaluation (ODE) is to develop and interpret regulations and guidelines regarding premarket notification submissions (510(k)s), premarket approval applications (PMAs), product development protocols (PDPs), device classifications, and investigational device exemptions (IDEs). The ODE guidance memoranda, affectionately referred to as "Blue Book Memos", clarify these guidelines and will be added to this list as they become available. We hope you find these Blue Book Memos helpful in your understanding of ODE policies and procedures.
| 510(K) MEMORANDA | |||
 |
Procedures for Class II Device Exemptions from Premarket Notification 2/19/98 (K98-2) |  |
|
|
Determination of Intended Use for 510(k) Devices (Update to K98-1) 12/03/02 | |
 |
|
Deciding When to Submit a 510(k) for a Change to an Existing Device 1/10/97 (K97-1) | |
|
|
510(k) Requirements During Firm-Initiated Recalls 11/21/95 (K95-1) | |
|
|
510(k) Sign-Off Procedures 6/3/94 (K94-2) | |
|
|
510(k) Refuse to Accept Procedures 5/20/94 (K94-1) | |
|
|
510(k) Additional Information Procedures 7/23/93 (K93-1) | |
|
|
510(k) Sterility Review Guidance 2/12/90 (K90-1) [replaced by Guidance issued on 8/30/2002] |
||
|
Telephone Notification for Premarket Notifications (510(k)s) Under Review at 75 Days or Greater 6/08/89 (K89-2) [replaced by I93-1] |
||
|
Premarket Notification - Consistency of Reviews 2/28/89 (K89-1) | |
|
|
Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3) | |
|
|
510(k)Sign-off Procedures 6/8/89 (K86-2) [replaced by K94-2] | ||
| ADMINISTRATIVE MEMORANDA | |||
|
Fax & E-Mail Communication with Industry about Premarket Files Under Review 3/01/02 (A02-01) [replaced by guidance issued on 12/28/2007] |
||
|
Training for Supervisors 3/5/92 (A92-1) | |
 |
|
Training Checklist for New Reviewers 5/18/90 (A90-4) | |
|
|
ODE Mentor Program 5/4/90 (A90-3) | |
|
|
ODE Peer Review Promotion Process 4/24/90 (A90-2) | |
|
|
Approval of Speaking Engagements 4/24/90 (A90-1) | |
|
|
Training for ODE Employees 7/19/89 (A89-1) | |
|
|
Sabbatical Program for ODE Reviewers 10/23/86 (A-86-2) | |
|
|
Guidance on Media Contacts 10/16/86 (A86-1) | |
|
| GENERAL PROGRAM MEMORANDA | |||
|
Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities - #G03-1 | |
|
|
Intercenter Consultative/Collaborative Review Process 10/3/02 (G02-1) | |
|
|
PMA/510(k) Expedited Review 3/20/98 [replaced by guidance] | ||
|
Guidance on Amended Procedures for Advisory Panel Meetings 3/20/98 (G98-3) | |
|
|
Guidance on the Recognition and Use of Consensus Standards 2/19/98 (G98-2) | |
|
|
New Section 513(f)(2) - Evaluation of Automatic Class III Designation 2/19/98 (G98-1) | |
|
|
Memorandum of Understanding Regarding Patient Labeling Review 8/9/96 (G96-3) | |
|
|
ODE SOP for Development and Use of Guidance Documents 6/6/96 (G96-2) | |
|
|
Use of International Standard ISO-10993-5/1/95 (G95-1) | |
|
|
PMA/510(k) Expedited Review 5/20/94 (G94-2)[replaced by guidance] | ||
|
Documentation and Resolution of Differences of Opinion on Product Evaluation 12/23/93 (G93-1) | |
|
|
Device Labeling Guidance 3/8/91(G91-1) | |
|
|
Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories, and Related Measurement Devices 10/19/90 (G90-2) | |
|
|
Consolidated Review of Submissions for Lasers and Accesories 10/19/90 (G90-1) | |
|
|
IDE/PMA Expedited Review Process 10/25/89 (G89-2) [replaced by G98-4] | ||
|
Toxicology Risk Assessment Committee 8/9/89 (G-89-1) | |
|
|
Review of Laser Submissions 4/15/88 (G88-1) | |
|
|
ODE Executive Secretary Guidance Manual 8/7/87 (G87-3) | |
|
|
Tripartite Biocompatibility Guidance 4/24/87 (G87-1) | |
|
| IDE MEMORANDA | |||
|
Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices 10/26/01 (D01-1) | |
|
|
Pre-IDE Program: Issues and Answers 3/25/99 (D99-1) | |
|
|
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Guidance for Industry and CDRH Staff (P98-3) | |
|
|
Continued Access to Investigational Devices 7/15/96 (D96-1) | |
|
|
Implementation of FDA Interagency Agreement 9/8/95 (D95-2) | |
|
|
Goals and Initiatives for the IDE Program 7/12/95 (D95-1) | |
|
|
IDE Refuse to Accept Procedures 5/20/94 (D94-1) | |
|
|
Review of IDEs for Feasibility Studies 5/17/89 (D89-1) | |
|
|
Guidance on Significant and Non-significant Risk Device Studies 7/25/86 (D86-1) | |
|
| PMA MEMORANDA | |||
|
30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes 2/19/98 (P98-4) | |
|
|
Early Collaboration Meetings Under the FDA Modernization Act 2/19/98 (P98-3) | |
|
|
Guidance on PMA Interactive Procedures for Day-100 Meetings And Subsequent Deficiencies 2/19/98 (P98-2) | |
|
|
Bioresearch Monitoring Agreement for PMAs and PDPs 3/11/98 (P98-1) | |
|
|
Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages 10/10/97 (P97-1) | |
|
|
Premarket Approval Application (PMA) Closure 7/8/94 (P94-2) | |
|
|
PMA Refuse to File Procedures 5/2/94 (P94-1) [replaced by Guidance Document] | ||
|
PMA Summaries of Safety and Effectiveness and Federal Register Notices of PMA Approvals - Review by the Office of General Counsel (Revised) 6/11/93 (P93-1) [replaced by G96-1] | ||
|
PMA Compliance Program 5/3/91(P91-3) | |
|
|
Panel Review of Premarket Approval Applications 5/3/91 (P91-2) | |
|
|
PMA Filing Decision 5/18/90 (P90-2) [replaced by Guidance Document] | ||
|
Panel Report and Recommendations on PMA Approvals 4/18/86 (P86-5) | |
|
|
PMA Progress Reports to Applicants 1/31/86 (P86-2) [replaced by I93-1] | ||
|
PMA Summaries of Safety and Effectiveness - Review by the Office of General Counsel 7/25/86 (P85-1) [replaced by P93-1, G96-1] | ||
| PROGRAM INTEGRITY MEMORANDA | |||
|
510(k) Quality Review Program 3/28/96 (I96-1) | |
|
|
Telephone Communications Between ODE Staff and Manufacturers 1/29/93 (I93-1) | |
|
|
Nondisclosure of Financially Sensitive Information 3/5/92 (I92-1) | |
|
|
Integrity of Data and Information Submitted to ODE 5/29/91 (I91-2) | |
|
|
Document Review Processing 2/12/92 (I91-1) | |
|
|
Document Control Procedures 9/26/90 (I90-3) | |
|
|
Assignment of Review Documents 8/24/90 (I90-2) | |
|
|
Policy Development and Review Procedures 2/15/90 (I90-1) | |
|
|
Meeting with Regulated Industry 11/20/89 (I89-3) | |
|
|
Reassignment of Review Documents 10/25/89 (I89-2) [replaced by I90-2] | ||
|
Integrity of the Medical Device Review Process 10/25/89 (I89-1) | |
|
Updated January 23, 2008
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
