CDRH’s 2015 Weather Forecast Predicts A Storm of Guidance Documents

Earlier this month, FDA’s Center for Devices and Radiological Health issued its FY 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance.  CDRH lists 28 guidance documents in total.  The “A-list” includes both draft and final guidances that CDRH intends to publish by January 2016, and the “B-list” includes guidance documents that it intends to publish “as resources permit.”   CDRH is required by the Medical Device User Fee Amendments of 2012 to publish these lists.

The “A-list” includes the following final and draft guidances:

1. Applying Human Factors & Usability Engineering to Optimize Medical Device Design (Final);
2. 510(k) Submissions for Medical Devices that Include Antimicrobial Agents  (Final);
3. Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval (Final);
4. Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (Final);
5. Framework for Regulatory Oversight of Laboratory Developed Tests (Final);
6. FDA Notification and Medical Device Reporting for Laboratory Developed Tests (Final);
7. Coronary Drug Eluting Stents-Nonclinical and Clinical Studies (Final);
8. Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements (Final);
9. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (Final);
10. Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications (Final);
11. Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile (Final);
12. Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing Biocompatibility (Final);
13. General Wellness Products (now published in Draft);
14. Medical Device Accessories (now published in Draft);
15. Medical Device Decision Support Software (Draft);
16. Benefit-Risk Factors to Consider When Reviewing IDE Submissions (Draft);
17. UDI Direct Marking (Draft);
18. Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements (Draft);
19. Adaptive Design for Medical Device Clinical Studies (Draft); and
20. UDI FAQs (Draft).

The “B-list” includes the following:

1. Finalizing various existing draft guidance documents;
2. Medical Device Interoperability (Draft);
3. Transfer of Ownership of a Premarket Notification: Questions & Answers (Draft);
4. Direct Access Genetic In Vitro Diagnostics Testing (also known as Direct to Consumer Genetic Testing) (Draft);
5. Patient Access to Information (Draft);
6. 3D Printing (Technical) (Draft);
7. Manufacturing Site Change Supplements (Draft); and
8. Use of Symbols in Labeling (Draft).

Significantly, CDRH acknowledges that it is not realistic for FDA to publish all guidances on both the “A-list” and the “B-list” by January 2016 and that priorities may change throughout the year.

The Agency also published a third list, containing final guidance documents that were issued in 2005, 1995, and 1985 and are now subject to retrospective review.  CDRH will conduct “a staged review of previously issued final guidances in collaboration with stakeholders,” and it is seeking feedback on whether such guidance documents should be revised.  These guidance documents are:

1985 Final Guidances include:

1. Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF – 90KB) (1/20/1985);
2. User Instruction Hazard Warnings (Laser Notice 35) (PDF – 63KB) (2/5/1985);
3. Policy on Warning Label Required on Sunlamp Products (PDF – 71KB) (6/25/1985);
4. Low Power Laser Exemption (Laser Notice 36) (PDF – 101KB) (8/23/1985); and
5. Walk-In Workstations (Laser Notice 37) (PDF – 86KB) (10/21/1985).

1995 Final Guidances include:

1. Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters (PDF – 896KB) (3/15/1995);
2. Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians’ Office Laboratory and Home Use (7-13-1995);
3. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment (7/26/1995);
4. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes (7/26/1995);
5. Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles (7/26/1995);
6. Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Immersion Hydrobaths (7/26/1995);
7. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables(7/26/1995);
8. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems (7/26/1995);
9. Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators (7/26/1995);
10. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices (7/26/1995);
11. User Instruction for Medical Products (Laser Notice 44) (PDF – 123KB) (8/11/1995);
12. Labeling of Laser Products (Laser Notice 45) (PDF – 90KB) (8/15/1995); and
13. Guidance On The Content Of Premarket Notification [510(k)] Submissions For Protective Restraints (Text Only) (12/1/1995).

2005 Final Guidances include:

1. Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (1/14/2005);
2. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005);
3. Guidance for Industry and FDA Staff – Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (7/27/2005);
4. Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features (8/9/2005);
5. Guidance for Industry – Review Criteria for Assessment of C Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays (9/22/2005);
6. Guidance for Industry and FDA Staff: Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions (10/26/2005);
7. Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 C.F.R. § 1040.30) (11/6/2005);
8. Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures (11/10/2005); and
9. Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s (11/17/2005).

FDA has established a docket for comments on any or all of the proposed FY2015 guidance documents or guidance documents subject to CDRH’s focused retrospective review.  FDA invites stakeholders to submit comments on the guidance documents listed, the relative priority of guidance documents for Agency attention and/or suggestions that CDRH revise or withdraw a final guidance document that issued previously in 2005, 1995 or 1985.