This alert explores FDA’s current practice of relying on draft and final guidance policies during inspections against the backdrop of this recent memorandum.Background on Form 483 FDA inspects section 503A pharmacies under 21 U.S. Code § 374(a) and inspects outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDCA provides that FDA may “at reasonable times and within reasonable limits…[inspect] all pertinent equipment, finished and unfinished materials, containers, and labeling therein….

By John R. Fleder –Although there are many areas where practitioners and others disagree regarding the FDC Act, there is at least one subject that seems to generate universal agreement: FDA has the authority to issue a Form 482 to a companies subject to inspection under 21 U.S.C. § 374, and those companies have no right to refuse FDA’s entry to a facility. FDA has publicly articulated this principle many times and acted accordingly when questioned at the front door by a company that questions FDA’s right to inspection without a warrant and without the firm’s consent.

ons. Under FDA regulations, a manufacturer includes a “remanufacturer” – which does any act to a finished device that significantly changes the device’s performance, safety specifications or intended use.25 A laboratory is a device remanufacturer if it modifies an existing IVD that it did not develop itself in a way that significantly changes the device’s performance, safety specifications or intended use, and the modified IVD is expected to comply with applicable device requirements, as outlined in the phase-out policy, if finalized.Timing of different phase-out stages. The general enforcement-discretion approach for LDTs would be phased out over four years after FDA publishes a final phase-out policy. Thus, the timing for each stage is based on the date FDA publishes the final phase-out policy and is not based on when the previous stage ends.Laboratory inspection. Laboratories that manufacture IVDs are subject to inspection under the FDA’s inspection authority (codified in the FDCA, 21 USC § 374).Treatment of modular PMA. Under FDA’s proposed phase-out policy, FDA generally would not intend to enforce against IVDs offered as LDTs after a PMA has been submitted, within the three-and-a-half-year time frame, which includes all modular PMA submissions if a manufacturer is pursuing the modular PMA approach.Enforcement discretion exercised after LDTs are submitted for premarket review. Under FDA’s proposed policy, FDA generally would not intend to enforce premarket review requirements against IVDs offered as LDTs after a PMA, 510(k) or De Novo request has been submitted within the appropriate time frame until FDA completes its review.Fees associated with premarket review. There are user fees associated with stage 2 (registration and listing) and stages 4 and 5 (premarket review). The current user fee program includes considerations for small business.Applicability of the least burdensome approach. FDA considers the least burdensome approach when evaluating premarket submissions con

Below are some key sections of the new proposed rule.Inspection.The proposed rule does not impact FDA’s authority to conduct inspections under section 704 of the Food Drug and Cosmetic Act (“FD&C Act”) (21 U.S.C. § 374). However, FDA intends to replace its current inspection approach for medical devices, the Quality System Inspection Technique (QSIT), with an inspection approach that will be consistent with the requirements of the proposed Part 820 as finalized.

Instead, FDA proposes conforming amendments to the references in Part 4 to now reference the corresponding clauses in ISO 13485, and specifically requests comment on the proposed conforming amendments and whether additional changes are necessary to assure compliance with Part 4. FDA believes the QS requirements outlined in Part 4 are not fundamentally different than the corresponding requirements in ISO 13485.F. InspectionsAlthough the proposed rule does not impact FDA’s authority to conduct inspections under section 704 of the FD&C Act (21 U.S.C. § 374), FDA intends to replace its current inspection approach for medical devices, the Quality System Inspection Technique (QSIT), with an inspection approach that will be consistent with the requirements of the QMSR when finalized. Similar to the current QSIT inspection approach, these inspections would involve the collection of information to support observations noted during the inspection and those included on a Form FDA 483, as appropriate and necessary.

7 Id.; FDA, Guidance for Industry, Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers (August 2020), updated on January 29, 2021 (https://www.fda.gov/media/141312/download).8 Federal Food, Drug & Cosmetic Act (“FD&C Act”) § 704(a)(4), 21 U.S.C. § 374(a)(4).9 FDA, Guidance for Industry, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (Apr. 2021), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remote-interactive-evaluations-drug-manufacturing-and-bioresearch-monitoring-facilities-during-covid.

In Tuesday's Report: U.S. GOP unveils relief proposal; FDA increases use of virtual tools & optimizes inspectional activities; Biden to fund mass production of OTC test; and an analysis of how blockchain could help supply chain issues.Tuesday, 2 February 2021The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due to the pandemic, FDA has been forced to pilot new inspectional initiatives, including increased use of records requests under 21 USC 374(a)(4) and increased reliance other health authorities’ inspections under the Mutual Reliance Initiative (MRI). FDA has published a summary report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative, which is aimed at strengthening FDA’s ongoing COVID-19 response and building the agency’s resilience to respond to future emergencies, including by identifying several “broad cross-cutting ‘Action Areas’ that reflect ongoing and potential prospective actions.”

The future of inspections under FDA’s COVID-19 PREPP initiativeThe COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due to the pandemic, FDA has been forced to pilot new inspectional initiatives, including increased use of records requests under 21 USC 374(a)(4) and increased reliance other health authorities’ inspections under the Mutual Reliance Initiative (MRI).On January 13, FDA published a summary report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative, which was launched internally in April 2020 and announced publicly in August 2020. According to the summary report, the PREPP initiative is aimed at strengthening FDA’s ongoing COVID-19 response and building the agency’s resilience to respond to future emergencies, including by identifying several “broad cross-cutting ‘Action Areas’ that reflect ongoing and potential prospective actions.”

[7] Id. at 3.[8] Id. at 4, citing to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 374(a)(4)).[9] Id.

McMeekin acknowledged that “most foreign inspections are preannounced” but explained that preannouncements are often necessary to verify that a site is performing activities that fall within FDA’s jurisdiction and to ensure the availability of personnel and records. In addition, McMeekin noted that because FDA’s statutory inspectional authority, 21 USC 374, does not apply to foreign facilities, preannouncement is used to ensure FDA will be permitted to conduct the inspection.GAO health care director Mary Denigan-Macauley expressed concerns that FDA provides up to three months’ notice prior to foreign inspections and relies on foreign personnel to translate key documents.