- October 24, 2019
“The current wording of the draft guidance…provides FDA with so much flexibility to deviate from these processes and standards that they are rendered meaningless,” writes AdvaMed Senior Executive Vice President for Technology and Regulatory Affairs Janet Trunzo. The group seeks revisions that address “this shortcoming” and align with least burdensome principles.
AdvaMed recommends clarifying certain situations when Agency Investigators can make exceptions to the uniform processes and standards, requiring supervisory reviews of such decisions as well as establishing, regularly reviewing and publishing metrics on FDA goals.
Trunzo stops short of suggesting a redraft, adding that, “including the risk-based concept in the draft guidance will send a clear and unequivocal message that the principle of risk-based inspections is to be continued.” For-cause inspections should be limited to the specific issues initiated by the Medical Device Single Audit Program (MDSAP), AdvaMed argues.
MDSAP has continued to see participation growth in recent years, particularly among US manufacturing sites. AdvaMed touts the benefits of MDSAP in reducing redundant inspections and FDA says it has plans for MDSAP, from the ISO 13485:2016 shift to creating a medical device single review program.
AdvaMed asks in another comment if FDA can clarify whether the requirements apply to combination products’ device components. FDARA requirements on uniform processes and standards “are required regardless of the center that is leading or participating in the inspection,” Trunzo says.
REFERENCE: RAPS Regulatory Focus; 10 JUL 2019; Ana Mulero