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# FDA Provides More Details on Legislative Proposals
- URL: https://www.fdaweb.com/fda-provides-more-details-on-legislative-proposals/
- Published: 2022-03-29T12:00:00.000Z
- Updated: 2026-09-14T17:38:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151472

More details are trickling out of FDA on the package of legislative proposals that were included in the Biden Administration’s fiscal year 2023 budget proposal for the agency 3/28 ([see earlier story](https://www.fdaweb.com/fda-budget-request-seeks-2-1-billion-spending-boost/)), including expanded authority to enhance remote regulatory assessments that were widely used during the Covid-19 pandemic and more authority to ensure medical device firms implement cybersecurity protections.

In a just-posted FDA [executive summary](https://www.fda.gov/media/157194/download?ref=fdaweb.com) on the legislative proposals, the agency notes that its authority to conduct remote regulatory assessments is “limited to requests for records and other information in advance or in lieu of drug inspections and FDA currently lacks authority to require any establishment to participate in remote interactive evaluations.” Industry’s participation in such assessments is voluntary for non-drug establishments, and firms can refuse to provide records or other information. The agency says the proposal would “expand FDA’s authority to request records or other information in advance of or in lieu of inspections to include all FDA-regulated products by revising Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to explicitly include medical device, food, tobacco product, and cosmetic establishments, and to clarify applicability for biomedical research monitoring (BIMO) inspections.

“Additionally,” the summary continues, “this proposal would add explicit authority to conduct remote regulatory assessments with establishments, which may include remote interactive evaluations such as livestreaming video of operations, teleconferences, and screen sharing, so FDA may interact virtually with an establishment and assess its compliance with applicable laws and regulations.” The agency says that allowing it to conduct certain oversight activities prior to arriving for, or instead of an inspection, would improve the efficiency of its resources and reduce on-site investigator inspection time.

FDA’s cybersecurity legislative proposal is intended to address the lack of a statutory mandate that expressly requires medical device manufacturers to address cybersecurity. “This proposal would advance medical device safety by explicitly requiring that medical device manufacturers design cybersecurity into their devices and by ensuring that FDA and the public have certain information about device cybersecurity,” the FDA summary says.

“Specifically,” it adds, “FDA seeks to have express authority to require: that premarket submissions to FDA include evidence demonstrating reasonable assurance of the device’s safety and effectiveness for purposes of cybersecurity; that marketed devices demonstrate a reasonable assurance of the device’s safety and effectiveness for purposes of cybersecurity; that devices have the capability to be updated and patched in a timely manner; that manufacturers provide a device Software Bill of Materials (SBOM) with their devices so users know which components of their devices are or may be subject to cyber threats; and that device manufacturers publicly disclose when they learn of a cybersecurity vulnerability so users know when a device may be vulnerable, and to provide direction to users to reduce their risk.”

Regarding changes to the accelerated approval program, a legislative proposal is targeting FDA’s struggles with getting firms to conduct timely post-approval confirmatory studies. The agency is seeking to add a provision to the FD&C Act that “would help provide greater assurance at the time of a drug product’s accelerated approval that the confirmatory study will progress in a timely manner, and reap high-quality, interpretable results.”

Specifically, it would “**1**) revise section 506(c)(2)(A) of the FD&C Act such that FDA may require, as a condition of a drug product application’s acceptance for filing, or as a condition of a drug product’s receipt of accelerated approval, that a drug sponsor must first demonstrate that a proposed post-approval (i.e., confirmatory) study is adequately designed to verify and describe clinical benefit and can be completed in a timely manner; and **2**) revise section 506(c)(3) so that FDA can follow its dispute resolution procedures for drug applications when withdrawing a drug product’s accelerated approval,” the summary says.

It also provides more details on proposals to amend the 180-day exclusivity provisions for first generic drug approvals, provide authority to require destruction of imported products that pose a significant public health risk, reduce or prevent medical device shortages, and modernize the Dietary Supplement Health and Education Act, among others.