900.12(a)(3)(i)(A): Be State licensed or approved or have certification in an appropriate specialty area by one of the bodies determined by FDA to have procedures and requirements to ensure that medical physicists certified by the body are competent to perform physics surveys.
The FDA recognizes medical physicists certified with specialties in diagnostic radiological physics, radiological physics, or diagnostic imaging physics by the following organizations:
- American Board of Radiology (ABR)
- American Board of Medical Physics (ABMP).
A medical physicist who is state licensed or state approved in one state is qualified to conduct surveys in any other state under MQSA. However, MQSA permits states to have more stringent requirements than the MQSA standards. If the second state has regulations, policies, guidelines, or some other means based on regulatory authority that allows it to regulate medical physicists, then, under state law, the medical physicist must meet its requirements in order to practice. It can require the physicist to have its approval to practice within its borders in addition to meeting one of the options under MQSA. The physicist could still be qualified under MQSA, but physicists lacking such approval would be cited under the state regulations.
Attestation is not acceptable for State licenses, State approvals, or board certification.
- Are medical physicists who were board certified, State licensed, or State approved prior to April 28, 1999, exempt from having to meet the new requirements regarding their degree, semester hours of physics, and training on conducting surveys? What about survey experience?
- FDA-approved medical physicist certification boards have started issuing certificates that have an expiration date. If a medical physicist allows his board certification to expire, must he or she obtain recertification to continue providing services to mammography facilities?