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.
- Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1) Reflects the elimination of the sunset provision of Section 513(i)(1)(E) of the Federal Food, Drug, and Cosmetic Act (the Act).
- 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
- Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.9MB) Procedures and criteria used in assessing whether a 510(k) submission meets minimum threshold of acceptability and should be accepted for substantive review.
- Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff (PDF - 386KB) Updates and clarifies sterilization processes that we recommend sponsors include in 510(k)s for devices labeled as sterile, and details about pyrogenicity info.
- Premarket Notification - Consistency of Reviews #K89-1 (Blue Book Memo) Outlines methods for identifying important issues that require uniform treatment across the divisions of the Office of Device Evaluation, and more.
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff (PDF - 844KB) Provides guidance to industry and FDA staff about current review practices for premarket notification (510(k)) submissions.
General Program Memoranda
- Procedures for Meetings of the Medical Devices Advisory Committee - Guidance for Industry and Food and Drug Administration Staff (PDF - 443KB)
Replaces Guidance for Industry and FDA Staff: Guidance on Amended Procedures for Advisory Panel Meetings
- De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff (PDF - 139KB)
Replaces New Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff
- Device Labeling Guidance #G91-1 (Blue Book Memo) Formalizes guidance to ODE reviewers concerning their review of labeling in device marketing submissionsr especially premarket approval applications (PhAs).
- FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 573KB)
- Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff 310
- Goals and Initiatives for the IDE Program #D95-1 (blue book memo) The purpose of this memorandum is to establish procedures for the efficient review of IDEs and to identify performance goals for the IDE Program.
- Review of IDEs for Feasibility Studies #D89-1 (Blue Book Memo) Purpose and procedure for the review of IDE applications for feasibility studies involving limited numbers of human subjects.
- Procedures for Meetings of the Medical Devices Advisory Committee - Guidance for Industry and Food and Drug Administration Staff (PDF - 443KB) Information regarding the processes for meetings of the Medical Devices Advisory Committee panels other than the Medical Devices Dispute Resolution Panel (DRP).
- 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes - Guidance for Industry and FDA Staff (PDF - 80KB) Provides guidance on the changes FDA believes may qualify for the 30-day notice and the changes that generally do not qualify.
- 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 The FDA Modernization Act of 1997 (Pub. L. 105-115) added new section 515(d)(3) to the FD&C Act.
- Bioresearch Monitoring Agreement for PMAs and PDPs - February 23, 1998