The FDA released its four main priorities for 2012, and the focus of the FDA will
Fullyimplement a total product life cycle approach byenhancing and integrating the premarket, postmarket, and compliance information and functions.
- Enhance communication and transparency with stakeholders, internal communications, and supporting two-way communication.
- Strengthen workforce and workplace with efficient administration of CDRH programs.
- Proactively facilitate innovation to address unmet public health needs to facilitate the development of innovative, safe and effective medical devices and advance regulatory science.
That’s quite a tall order for the upcoming year! However, the FDA did have a productive year in
- Released: Plan of Action for Implementation of 510(k) and Science Recommendations, and several additional efforts to improve pre-market programs. IMARC published an in-depth look on this in our whitepaper on 510(k).
- FDA announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH). Read more in IMARC’s Blog.
- The draft guidance on the study and evaluation of gender differences in medical device clinical studies- elaborated on in a previous IMARC Blog.
- The FDA launched a new Web resource called FDA Basics for Industry to help companies and other save time and resources in their interactions with the agency in an effort to improve transparency with the FDA.
- The draft guidance "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations" clarifies the FDA's process for approving
clinicaltrial of medical devices- covered by a previous IMARC Blog.
- The draft guidance on the development and review of Investigational Device Exemption (IDE) applications for early feasibility studies of significant risk devices- read more about it in IMARC's Blog.
- FDA released a draft guidance document entitled “Guidance for Industry. Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring,” which aims to provide more concrete monitoring guidance and explore the possibility of alternative approaches to monitoring based on a
risk-assessment. Our Blog covers this topic in greater detail.
MassDevice recently released an article on the FDA’s 2012 goals as well, emphasizing the FDA’s strategic priorities “including final versions of all guidance documents, guidelines for acceptable clinical data from foreign countries, streamlining the recall process and creating a framework for post-market surveillance.” The article also references the watchdog’s agency’s Center for Devices & Radiological Health plans to concentrate on fully implementing a "total product life cycle approach," enhance its internal and external communication and transparency, strengthen its workforce, and "proactively facilitate innovation."
What goals would you like to see the FDA achieve this year for the Medical Device Industry? Would you add anything to the “To Do” list?