Radiation-Emitting Products

Medical Physicist Alternative Initial Qualifications

Policy Guidance Help System logo

 

Citation:

900.12(a)(3)(ii)(A)(B)(1)(2)(3):

(A) Have qualified as a medical physicist under paragraph (a)(3) of this section of FDA’s interim regulations and retained that qualification by maintenance of the active status of any licensure, approval, or certification required under the interim regulations; and

(B): Prior to the April 28, 1999 have:

1. A bachelor’s degree or higher in a physical science from an accredited institution with no less than 10 semester hours or equivalent of college undergraduate or graduate level physics,

2. Forty contact hours of documented specialized training in conducting surveys of mammography facilities and,

3. Have the experience of conducting surveys of at least 1 mammography facility and a total of at least 20 mammography units. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. The training and experience requirements must be met after fulfilling the degree requirement.

Back to Top Arrow


Discussion:

The FDA recognizes medical physicists certified with specialties in diagnostic radiological physics or radiological physics by the American Board of Radiology (ABR) or with a specialty in diagnostic imaging physics from the 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 it's 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 would still be qualified under MQSA, but physicists lacking such approval could be cited under the state regulations.

Attestation is not acceptable for academic degrees, state licenses, state approvals, or board or certification.

According to section 900.2(ll) Physical Science means physics, chemistry, radiation science (including medical physics and health physics), and engineering.

Copies of certificates earned or other documentation from the training provider will suffice for the initial training qualification. If documentation is not available, proper attestation will be acceptable for records dated up to October 1, 1994. FDA will continue to accept a limited form of attestation for CME received after October 1, 1994, in certain cases. (see Attestation - Acceptable Uses for Personnel Requirements)

When converting semester hours to CME’s, an academic semester hour should be considered equal to 10 class hours and thus 10 continuing education credits. This 10 to 1 ratio is useful when you have to combine academic credit and continuing education units to determine if a requirement is met. However, if the facility can document that it took a different number of class hours than 10 (e.g., 12, 14, etc.) to earn 1 semester hour of credit, then the actual number of class hours should be used in making the conversion.

Back to Top Arrow


Questions
  1. A physicist was performing facility surveys prior to April 28, 1999, with a bachelor's degree in a physical science as defined by FDA. His or her State approval is still current after April 28, 1999. Is this degree acceptable as meeting the alternative initial requirement?
  2. A State-approved medical physicist and has been conducting medical physicist surveys under the interim regulations. He or she has well over 40 contact hours of documented specialized training in conducting surveys of mammography facilities and has performed dozens of facility surveys. However, the physicist does not have a physical science degree and will obtain a bachelor's degree in physics by April 28, 1999. Will his or her survey experience count?
  3. There are a variety of sub-specialties and corresponding degrees within the physical sciences listed in the definition. Do they all meet the requirements for a physical science degree or only certain ones?
  4. All medical physicists must have specialized training in conducting surveys of mammography facilities. What type of training can be used to meet this requirement? Can continuing medical education (CME) be counted to meet this requirement or does it have to be formal, academic training? Can CME be used to meet both the "15 CME in 36-month" requirement and also to meet this "specialized training in conducting surveys" requirement?
  5. Prior to October 27, 1997, physicists who had two years of experience in conducting performance evaluations of mammography equipment had sufficient experience to perform surveys. Will this experience meet the initial experience requirement under the final regulations?
  6. What is the conversion factor used to convert quarter hours to semester hours?
  7. Is a bachelor's degree in Radiologic Technology sufficient to meet the degree requirement?
  8. I have a degree in a physical science obtained at a non-US institution. Is that acceptable toward meeting the degree requirement?
  9. I have a bachelor's (or higher) degree specifically in physics. Do I still need to document my number of semester hours in physics?

Back to Top Arrow


 

Page Last Updated: 07/25/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.