Third Party Recognition Boards (TPRs) provide manufacturers of eligible devices a voluntary alternative review process that may yield more rapid 510(k) decisions. Recently FDA issued draft guidance, “Accreditation and Reaccreditation Process for Firms under the Third Party Review Program.” TPRs are intended to enable FDA to use its resources for reviewing higher-risk and complex devices and also hopefully increase the review times for the medical device industry.
Not all devices can be reviewed using TPR. According to the guidance, “FDA’s TPR includes a number of features designed to maintain a high level of quality in the review of 510(k)s by TPRs and to minimize risks to the public. These include the exclusion of all class III devices and any class II devices that are intended to be permanently implantable or life sustaining or life supporting, or, subject to the limitations of the FD&C Act, that require clinical data.”
What’s involved in the process to become an accredited TPR? In order for a firm to demonstrate meeting the qualifications for a TPR, the following information must be provided to FDA:
- Administrative information
- Basic contact and firm information
- Information to assess degree of independence from device manufactures and distributers
- Listing of accreditations
- Certification/agreement statement signed by the most responsible individual at the firm
- Including a certification that the firm will at all times while accredited by FDA be in conformity with the International Medical Device Regulator's Forum (IMDRF) and International Organization for Standardization (ISO) requirements
- Certification of eCopy understanding
- Statement of compliance with the eCopy requirements for premarket submissions as described in the guidance titled, “eCopy Program for Medical Device Submissions”
- Certification that the firm has an adequate code of conduct
- Certification that the firm will ensure competency
- By meeting general competency requirements for the organization and competency requirements for product assessors or product reviewer
The guidance also provides information on reaccreditation by FDA. A new accreditation is needed every three years at a minimum, and requests should follow the same procedures as the initial requests. FDA may consider past premarket review performance to ensure the TPR continues to meet accreditation standards.
It’s important to also note that participation in the TPR program is entirely voluntary and device manufacturers may continue to submit 510(k)s directly to FDA.
What are your thoughts on Third Part Reviewers? Do you think this will allow FDA to focus on more complex devices, resulting in faster review times? Share your thoughts and concerns regarding this new draft guidance and program below.
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