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Medical Devices
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Blue Book Memos - ODE Guidance Memoranda
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.
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510(k) Memoranda
- Procedures for Class II Device Exemptions from Premarket Notification #K98-2 (FDAMA)
- Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1)
857 - Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)
935 - Cover Letter: 510(k) Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo #K95-1) (Text Only)
406 - 510(k) Sign-Off Procedures #K94-2 (blue book memo) (Text Only)
308 - 510(k) Refuse to Accept Procedures #K94-1 (blue book memo) (Text Only)
401 - 510(k) Additional Information Procedures #K93-1 (blue book memo) (Text Only)
886 - Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA
Replaces 510(k) Sterility Review Guidance 2/12/90 (K90-1) - Telephone Communications Between ODE Staff and Manufacturers #I93-1 (blue book memo) (Text Only)
Replaces Telephone Notification for Premarket Notifications (510(k)s) Under Review at 75 Days or Greater 6/08/89 (K89-2) - Premarket Notification - Consistency of Reviews #K89-1 (blue Book memo) (Text Only)
339 - Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3)
390 - 510(k) Sign-Off Procedures #K94-2 (blue book memo) (Text Only)
Replaces 510(k)Sign-off Procedures 6/8/89 (K86-2)
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Administrative Memoranda
- Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
Replaces Fax & E-Mail Communication with Industry about Premarket Files Under Review 3/01/02 (A02-01) - Training for Supervisors - Administrative Memorandum #A92-1
- Training Checklist for New Reviewers - Administrative Memorandum #A90-4
- ODE Mentor Program - Administrative Memorandum #A90-3
- ODE Peer Review Promotion Process - Administrative Memorandum #A90-2
- Approval of Speaking Engagements - Administrative Memorandum #A90-1
- Training for ODE Employees - Administrative Memorandum #A89-1
- Sabbatical Program for ODE Reviewers - Administrative Memorandum #K86-2
- Guidance on Media Contacts - Administrative Memorandum #A86-1
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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 - #G02-1
- Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices
Replaces PMA/510(k) Expedited Review 3/20/98 - Guidance for Industry and FDA Staff: Guidance on Amended Procedures for Advisory Panel Meetings
Replaces Guidance on Amended Procedures for Advisory Panel Meetings 3/20/98 (G98-3) - Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards
Replaces 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, Guidance for Industry and CDRH Staff
Replaces New Section 513(f)(2) - Evaluation of Automatic Class III Designation 2/19/98 (G98-1) - Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3) (Text Only)
806 - ODE Standard Operating Procedures for the Development and Use of Guidance Documents - June 6, 1996 (G96-2)
- Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces #G87-1 #8294) (blue book memo)(Text Only)
164 - Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices
Replaces PMA/510(k) Expedited Review 5/20/94 (G94-2) - Documentation and Resolution of Differences of Opinion on Product Evaluations #G93-1 (blue book memo) (Text Only)
920 - Device Labeling Guidance #G91-1 (blue book memo) (Text Only)
414 - Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (blue book memo) (Text Only)
30 - Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices
Replaces IDE/PMA Expedited Review Process 10/25/89 (G89-2) - Toxicology Risk Assessment Committee #G89-1 (blue book memo) (Text Only)
363 - Review of Laser Submissions #G88-1 (blue book memo) (Text Only)
330 - ODE Executive Secretary Guidance Manual G87-3
1338 - Tripartite Biocompatibility Guidance - April 24, 1987 (G87-1)
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IDE Memoranda
- Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices - October 26, 2001 (#D01-01)
- Pre-IDE Program: Issues and Answers - March 25, 1999 (D99-1)
- Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff
310 - Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1) (Text Only)
872 - Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1) (Text Only)
872 - Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C -List #D95-2 (blue book memo) (Text Only)
106 - Goals and Initiatives for the IDE Program #D95-1 (blue book memo) (Text Only)
405 - IDE Refuse to Accept Procedures #D94-1 (blue book memo) (Text Only)
410 - Review of IDEs for Feasibility Studies #D89-1 (blue book memo) (Text Only)
362 - Significant Risk and Nonsignificant Risk Medical Device Studies
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PMA Memoranda
- 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH
795 - Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff
Replaces 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 - for Use by CDRH and Industry
322 - Bioresearch Monitoring Agreement for PMAs and PDPs - February 23, 1998
- Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages - October 10, 1997 (P97-1) (Text Only)
563 - Premarket Approval Application Filing Review
Replaces PMA Refuse to File Procedures 5/2/94 (P94-1) - PMA Compliance Program #P91-3 (blue book memo) (Text Only)
445 - Panel Review of Premarket Approval Applications #P91-2 (blue book memo) (Text Only)
444 - Premarket Approval Application Filing Review
Replaces PMA Filing Decision 5/18/90 (P90-2) - Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) (Text Only)
306 - Telephone Communications Between ODE Staff and Manufacturers #I93-1 (blue book memo) (Text Only)
Replaces PMA Progress Reports to Applicants 1/31/86 (P86-2)
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Program Integrity Memoranda
- 510(k) Quality Review Program (Blue Book Memo I96-1) (Text Only)
344 - Telephone Communications Between ODE Staff and Manufacturers #I93-1 (blue book memo) (Text Only)
360 - Nondisclosure of Financially Sensitive Information #I92-1 (blue book memo) (Text Only)
587 - Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) (Text Only)
447 - Document Review Processing #I91-1 (blue book memo) (Text Only)
446 - Document Control Procedures - September 26, 1990 (I90-3)
- Assignment of Review Documents #I90-2 (blue book memo) (Text Only)
366 - Policy Development and Review Procedures #I90-1 (blue book memo) (Text Only)
368 - Meetings with the Regulated Industry #I89-3 (blue book Memo)
367 - Integrity of the Medical Device Review Process 10/25/89 (I89-1)
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