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Regulatory Focus™ > News Articles > 2020 > 7 > FDA proposes changes to atherectomy, BPH device guidances

FDA proposes changes to atherectomy, BPH device guidances

Posted 13 July 2020 | By Michael Mezher 

FDA proposes changes to atherectomy, BPH device guidances

The US Food and Drug Administration (FDA) on Monday released two draft guidances proposing changes to two final device guidances, one on 510(k) submissions for peripheral vascular atherectomy devices and the other on clinical and nonclinical investigations for devices intended to treat benign prostatic hyperplasia (BPH).
 
Both draft guidances present updates to sections of the related final guidances that will be incorporated into the documents following a public consultation. FDA adds that other sections of the final guidances not addressed in the drafts will “not be substantively changed and will remain in effect.”
 
Peripheral vascular atherectomy devices
 
Just months after finalizing its guidance on 510(k) submissions for peripheral vascular atherectomy devices, FDA is proposing to change some of its recommendations pertaining to software, pyrogenicity testing and nonclinical performance testing. (RELATED: FDA revises atherectomy 510(K) guidance in response to cook comments, Regulatory Focus 12 February 2020).
 
For the section on software, FDA has added a new paragraph noting its acknowledgement of voluntary consensus standards supporting interoperability and pointing device makers to consult its guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, if their device can exchange information electronically with other devices or systems.
 
In the section on pyrogenicity, FDA now says that “peripheral vascular atherectomy devices should be labeled as ‘non-pyrogenic’ as they come into contact with circulating blood,” whereas the final guidance implies that some of the devices could not be labeled as non-pyrogenic and makes specific recommendations for those that are labeled as such.
 
The draft guidance also proposes changes to the agency’s recommendations for non-clinical performance testing, including simulated-use testing, debris removal and collection, orbit testing and adds a new subsection on particulate evaluation.
 
Benign prostatic hyperplasia devices
 
FDA is also proposing changes to its 2010 guidance on the nonclinical and clinical investigation of devices used to treat benign prostatic hyperplasia to include devices under four additional product codes and to make changes to its recommendations on animal, pilot and pivotal studies.
 
The three new product codes FDA intends to add to the scope of the guidance are KNS, PEW, PZP and NOY.
 
In its proposed revision to the section on animal studies, FDA removes a line noting that, “In some instances, animal studies may provide sufficient data to establish equivalent safety and effectiveness to a legally marketed device without clinical data.” The agency also makes minor revisions throughout the section, including its recommendations for animal studies needed for thermotherapy devices and stents.
 
For the section on pilot studies, FDA says it only intends to make a few changes, including renaming the section to “Pilot Clinical Study Recommendations,” and recommending that sponsors who plan to pool the results of pilot and pivotal studies plan for the pooling prospectively.
 
The most extensive revisions FDA is proposing are being made to the section on pivotal studies, where the agency suggests updating the sections on randomization and controls, study endpoints, statistical hypothesis, patient selection criteria, post-treatment evaluations and statistical analysis.

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