FDA Releases Plan for 2016 Medical Device Guidance

FDA Releases 2016 Medical Device Guidance Plan

As you can see from the list, several topics frequently mentioned by FDA last year, such as device unique identifiers (UDI), the Medical Device Reporting (MDR) process, and guidance documents will be issued this year to provide manufacturers and FDA officials with specific requirements and operational guidance. Finalize documents on the topics of human factors engineering, usability engineering, sterility validation, and biological evaluation that are broadly applicable to medical devices. In addition, we can see that the FDA pays special attention to blood glucose testing products. In the future, the FDA will have stricter review standards for such products. Aozida will notify the FDA of the release of the guidelines in a timely manner. It is recommended that relevant manufacturers facing the US market pay attention in time. .

CDRH plans to release priority medical device guidance ("A List") in fiscal year 2016: span>

FinalGuidance Topics

● General Health Products

● Medical Device Accessories

● Risk-Benefit Factors to Consider When Reviewing Clinical Device Exemption (IDE) Applications

● Unique Device Identifier (UDI) Direct Identification

● Adaptive Design for Medical Device Clinical Research

● Include patient care in premarket approvals, humanitarian device exemptions, and reclassification definitions Preference Considerations

● Apply Human Factors and Usability Engineering to Optimize Medical Device Design< /span>

● Regulatory Policy for Laboratory-built Reagents (LDTs)

● Submission and Review of Sterility Information for Devices Marked as Sterile

● ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing ( biocompatibility) applications

● Postmarketing Regulatory Studies under Chapter 522 of the Federal Food, Drug, and Cosmetic Act< /span>

● Medical Device Reporting (MDR) Procedure for Manufacturers

Draft Guidance Topics

● Medical Device Decision Support Software

● Use of Logos in Labels

● 510(k)change

● Software Changes

● 510(k) 3rd party audit process

● Joint development of companion diagnostic products

● Use real patient observation data to support medical device decisions

● Device Unique Identifier Tool

● Announcement on Emerging Post-Marketing Medical Device Emergencies

As guidance-writing resources allow, CDRH plans to publish a medical device guidance in fiscal year 2016 (" B list"):

Final Guidance Topics

● Computer Modeling Study Report in Medical Device Submission

● Prescription Bedside Blood Glucose Monitoring System

● Over-The-Counter Self-Testing Glucose Meter

● Radiation Biological Dosimetry

● Existing draft guidelines finalized

Draft Guidance Topics

● Medical Device Interoperability

● patient access to information

● Assessment and reporting of age, race and ethnicity data in medical device clinical studies< /span>

● Patient Individualized Devices for Orthopaedic Surgery

● Apply for 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver simultaneously span>

● Determine Unique Device Identifier (UDI)

● For Abdominal Surgical Mesh Key Quality Information for Devices

● Quality-critical information for vascular and neurological devices with hydrophilic or hydrophobic coatings