FDA www.fda.gov is looking for users that have experience with developing, testing, and commercializing products. The goal is to learn more about the experiences of small businesses and clinical investigators when translating an idea into a product.
When developing any product, especially medical devices, there are many facilitators and hurdles to innovation. Often a small team has to do everything. Clinicians do their best to become engineering experts, and engineers to their best to become clinical experts.
FDA wants to know from the public as they are applying for approval, which documents and services have helped benefit the individual or team. They also want to know what has been the most useful in terms of product development and clinical trial experience.
Examples of two situations where improvements resulted from additional information supplied:
- A regulatory submission was initiated by a small design team in a hospital for a new device. The development team read FDA Guidance documents that highlighted specific performance aspects that they had not previously considered. After checking the parameters, the team found they could improve the output of their device
- A clinician study or contract research study submitted an Investigational Device Exemption approval then received constructive feedback that led to improvement in the specificity of the clinical endpoints and a reduction in the number of subjects
For information on how to assist FDA email medsun@fda.hhs.gov and put User Experience in the subject line. Call 1-800-859-9821 if you would like to speak to staff at FDA.
In a second effort to obtain information, FDA seeks comments on a draft document on how to modernize and streamline clinical investigations, FDA’s goals are use EHRs in clinical investigations to promote interoperability of EHRs and electronic systems.
The FDA draft guidance for industry is entitled “Use of Electronic Health Record Data in Clinical Investigations.” The final document will assist sponsors, clinical investigators, contract research organizations, Institutional Review Boards (IRB) and other interested parties.
The goal is to ensure that the quality and the integrity of the EHR data collected used as electronic source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements.
Go to the Federal Register published May 17th, for information on FDA’s draft guidance before the FDA begins work on the final version. Comments must be submitted to www.regulations.gov by July 18, 2016.
A third place where information can be provided to the FDA is at their “Case for Quality Forum” to be held July 12, 2016 in Washington D.C. FDA has been working with industry to try to understand how device quality can be improved but wants more input from healthcare providers. For more information on the forum, email MedSun@fda.hhs.gov or call 800-859-9821.