Regulatory Focus™ > News Articles > FDA Plans to Release 28 Device Guidance Docs in 2015, Including on Software and Diagnostics

FDA Plans to Release 28 Device Guidance Docs in 2015, Including on Software and Diagnostics

Posted 08 January 2015 | By Alexander Gaffney, RAC

FDA Plans to Release 28 Device Guidance Docs in 2015, Including on Software and Diagnostics

The US Food and Drug Administration has just released a list of all medical device guidance documents it plans to release in 2015, including ones related to speeding up device submissions, regulating lab-developed tests (LDTs) and the regulation of decision support software.


The list, sometimes referred to as a "Guidance Agenda," is published on an annual basis by FDA's Center for Devices and Radiological Health, its medical device regulatory division. The list covers which guidance documents—documents which outline how FDA expects to enforce federal regulations and laws—are likely to be published in the coming fiscal year.

As in past years, the list is divided into two parts: An "A-List" of guidance documents it intends to prioritize in the coming year, and a "B-List" of documents it will publish "as resources permit."

FDA rarely, if ever, manages to publish all documents on its guidance agendas, either due to resource limitations, shifting priorities or political pushback against a proposal.

New Year, New Priorities

Among FDA's highest-priority guidance documents are several familiar to long-time industry watchers. FDA says it plans to release or finalize two documents as part of its effort to more closely regulate LDTs after releasing a draft guidance regulatory framework in August 2014. (Framework for Regulatory Oversight of Laboratory Developed Tests; FDA Notification and Medical Device Reporting for Laboratory Developed Tests)

However, the effort has been targeted by congressional Republicans, who say they worry the increased regulation could adversely affect medical innovation and the ability of patients to obtain relevant medical information.

FDA's guidance agenda also notes the agency plans to finalize a guidance outlining its new expedited approval program for high-need devices. A draft guidance document establishing the Expedited Access Premarket Approval program was released in April 2014.

Several new guidance documents are also set to be released in fiscal year 2015, CDRH said.

One new guidance will cover so-called "general wellness products," while another much-sought-after guidance will cover "medical device decision support software"—an area which has attracted much scrutiny for the agency.

Other high-priority guidance documents set to see publication include ones covering medical device accessories, direct marking under the unique device identification program, adaptive designs for device studies, and informed consent policies.


A-List: Final Guidance Topics
Applying Human Factors & Usability Engineering to Optimize Medical Device Design
510(k) Submissions for Medical Devices that Include Antimicrobial Agents 
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Need for Life Threatening of Irreversibly Debilitating Diseases or Conditions
Framework for Regulatory Oversight of Laboratory Developed Tests
FDA Notification and Medical Device Reporting for Laboratory Developed Tests
Coronary Drug Eluting Stents-Nonclinical and Clinical Studies
Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections With Small-bore Connectors Intended for Enteral Applications
Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile
Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility)
A-List: Draft Guidance Topics
General Wellness Products
Medical Device Accessories
Medical Device Decision Support Software
Benefit-Risk Factors to Consider When Reviewing IDE Submissions
UDI Direct Marking
Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements
Adaptive Design for Medical Device Clinical Studies
B-List: Final Guidance Topics
Finalizing existing draft guidance documents.
B-List: Draft Guidance Topics
Medical Device Interoperability
Transfer of Ownership of a Premarket Notification: Questions & Answers
Direct Access Genetic In Vitro Diagnostics Testing (also known as Direct to Consumer Genetic Testing) 
Patient Access to Information
3D Printing (Technical) 
Manufacturing Site Change Supplements
Use of Symbols in Labeling



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