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FDA’s New Inspections Council Whipping Up Policy Around Remote Regulatory Assessments

2021/11/26 14:34:57 Views:2385


Original from: Medtech Insight


One of the first jobs the US Food and Drug Administration’s new inspections council will take on is developing policy around the agency’s use of Remote Regulatory Assessments.


The FDA established its voluntary-for-industry RRA program in early 2021 as a way for the agency to check on a company’s regulatory compliance without having to send an investigator on-site to a manufacturing facility amidst the pandemic. RRAs involve, among other things, records requests and video interactions between the FDA and firms. (Also see "From Electronic Docs To FOIA Requests, FDA Lays Bare Its Process For Remote Regulatory Assessments" - Medtech Insight, 27 Apr, 2021.)


RRAs are not considered by the FDA to be official surveillance inspections, and the agency stresses that companies can turn down an assessment without fear of penalty. (Also see "To RRA, Or Not To RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments" - Medtech Insight, 10 Jun, 2021.)


In a 22 November report, the agency said its FDA Inspectional Affairs Council (FIAC), which was stood up in July, will develop RRA policy for all commodities the agency oversees.


“One of the top initial priorities identified by FIAC members is to develop an enterprise-wide policy and procedure for the use of Remote Regulatory Assessments,” the FDA says in its report, “An Update to the Resiliency Roadmap for FDA Inspectional Oversight.” “These assessments, which include … requests for voluntary submission of records and remote interactive evaluations, have been used throughout the pandemic to fortify our oversight efforts where inspections were not possible.”


The FIAC is an FDA-wide governance body whose goal is to “evaluate ways to modernize and optimize inspectional approaches and processes,” an agency official said on 16 November. The council, sponsored by the FDA commissioner and chaired by the associate commissioner of regulatory affairs, counts all center directors as members. (Also see "‘One FDA’: US Agency’s New Inspectional Affairs Council Takes Shape" - Medtech Insight, 20 Jul, 2021.)


“The FIAC initiative brings increased efficiency and consistency across FDA where appropriate, greater transparency, and improvement of business processes while providing insights into deploying various tools to help us complete our work,” the agency’s report says. “The FIAC will develop a multiyear strategic action plan to enhance our coordinated approach to inspections, information sharing, and other processes to accelerate evaluation and potential integration of new oversight methods and tools.”


The FDA’s report says the agency has performed more than 800 domestic and foreign RRAs since April. The report does not break that number down by commodity, however.


More Inspections Performed In FY ’21 Than Expected

The agency’s 22 November update is a follow-up to its May report, “Resiliency Roadmap for FDA Inspectional Oversight.”


In its original report the FDA said under a so-called “base-case scenario” that it would likely conduct only 851 of 3,229 planned domestic surveillance inspections of makers of human and animal medical products in fiscal year 2021, which ended on 30 September. (Also see "At Best, FDA Will Carry Out Only Half Of Domestic Surveillance Inspections In FY 2021, Report Says" - Medtech Insight, 5 May, 2021.)


But six months later, the update report says the agency overperformed by carrying out 1,139 inspections, a 34% increase over what it had estimated.


“FDA has exceeded the base-case scenario projections for FY ’21,” the update report says, crediting initiatives like the Remote Regulatory Assessments. “FDA’s development of new oversight approaches and expanded use of a variety of surveillance tools significantly contributed to the agency’s ability to exceed [its] goals.”


The report, however, does not say how many of those 1,139 inspections were of medical device manufacturers.


FDA Plots Foreign Inspection Comeback

One dark spot on the update report is the number of inspections of foreign device makers. The FDA said it conducted a mere four on-site inspections of facilities outside the US from April through September.


However, other overseas inspection activities happened outside of those months. For example, not noted in the report is an in-person inspection of a fifth firm in March – Tianjin Bolang Science-Technology Development Co. Ltd. in Tianjin Shi, China – that resulted in a warning letter. (Also see "FDA Warning Letter Recap, August 2021: On-Site Inspection Of Chinese Device Maker Uncovers Quality Systems Troubles" - Medtech Insight, 31 Aug, 2021.)


“FDA is currently developing a plan for resuming prioritized foreign inspections, including surveillance and application-related inspections, starting in February 2022 for all commodities,” the report says.


Source: FDA’s New Inspections Council Whipping Up Policy Around Remote Regulatory Assessments