Life Science Compliance Update

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January 02, 2018

Gottlieb Announces Medical Device Approval Process Update


FDA Commissioner Scott Gottlieb announced in a blog post the agency would be updating its medical device approval processes in order to accommodate rapidly advancing technologies. He described the modernization of FDA’s review framework would include the addition of a voluntary, alternative pathway for demonstrating substantial equivalence, and allow more flexibility to use modern criteria as the reference standard. Additionally, the new pathway will permit comparisons to standards that more closely approximate the kind of novel technology being evaluated. The new framework will be offered in addition to the current 510(k) pathway.


As established in the Medical Devices Amendments of 1976, manufacturers of new, moderate-risk devices must demonstrate substantial equivalence to a similar device legally marketed in the U.S. in order for a new device to be cleared by the FDA. The older devices acting as a comparator are called the predicate devices. This process is often known as the 510(k) pathway. However, this framework has not changed significantly in 40 years. Because the predicate devices that new products must compare themselves to may be up to 40 years old, it creates a burden for 510(k) applicants as newer devices have more advanced technologies. This makes it difficult to identify suitable predicate devices in order to conduct testing.

Modernizing 510(k) Review

Gottlieb announced that FDA will be publishing a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence in the first quarter of 2018. “This pathway will allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more closely approximate the kind of novel technology we’re being asked to evaluate.”

The new program allows device manufactures to demonstrate substantial equivalence by meeting safety and performance criteria. It would be available for pre-specified categories of devices and will be outlined in further FDA guidance. The program will also be voluntary and manufactures may still use the existing 510(k) pathway.

Pre- and Post-Market Requirements

Gottlieb notes the balance between “acceptable uncertainty” in the pre-market setting, relative to a product’s benefits and risks, and ultimately how much FDA can rely on post-market follow-up studies, has not been objectively defined in a framework by the agency. He reiterates the early 2018 guidance that will set forth factors the agency may consider when assessing acceptable uncertainty. It will also outline how issues may be resolved in the post-market setting, rather than the pre-market setting which will allow patients faster access to devices. He further notes several factors relevant to the assessment performed by FDA in its pre-market uncertainty review.

Other Policy

FDA also published a list of pending device-related guidance documents. Several of the guidance documents include the application of least burdensome and the Q-Submission program. According to Gottlieb, this “further demonstrate[s] FDA’s commitment to advancing modern regulatory policies that are designed to promote medical device innovation, while continuing to assure the safety and effectiveness of new products.”

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