MITA Comments on FDA ASCA Program

July 10, 2017

Re: FDA-2017-N-1067, Accreditation Scheme for Conformity Assessment Pilot Program

Dear Scott,

As the leading trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is responding to the public docket on Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. We encourage the FDA to continue to seek input on the pilot and implementation of the program.

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General Comments

MITA and its Members support ongoing efforts by the Agency to rely on established, harmonized, consensus-based standards to support applications that show products to be safe and effective.

Areas for clarification

MITA and its Members appreciate the information included in the FR notice, but request additional clarification on several aspects of the program. Specifically:

1. What in detail will be “ASCA specific program requirements” that have to be fulfilled by the lab?
2. Will there be only one Accreditation Body? Will it be limited to operation within the United States?
3. What is the process to become a pilot partner?
4. FDA should provide additional clarification on how the ASCA program is different from the third party review program. Our understanding is that the ASCA program would be useful for a subset of requirements that could be included in a 510(k) application. If this is the case, additional information about the value and benefits of the program would be appreciated.
5. Are there distinctions between first, second and third party test houses being considered for the ASCA program? If so, what are these distinctions?

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MITA Member companies count on careful consideration of this response and look forward to an outcome that meets their expectations. Further, MITA would be eager to continue its dialog with FDA as the ASCA program proceeds and to help actively with the many tasks before us.   If you have any questions, please contact Megan Hayes, Director, Regulatory and Standards Strategy at 703-841-3285 or by email at mhayes@medicalimaging.org.

 

Sincerely,

Patrick Hope

Executive Director, MITA

MITA is the collective voice of medical imaging equipment and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. These technologies include: magnetic resonance imaging (MRI), medical X-Ray equipment, computed tomography (CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, radiation therapy equipment, and imaging information systems.  Advancements in medical imaging are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. The industry is extremely important to American healthcare and noted for its continual drive for innovation, fast-as-possible product introduction cycles, complex technologies, and multifaceted supply chains.  Individually and collectively, these attributes result in unique concerns as the industry strives toward the goal of providing patients with the safest, most advanced medical imaging currently available.