Department of Health & Human Services (HHS) / Food and Drug Administration (FDA) Centers for Medicare & Medicaid Services (CMS)

• 21 C.F.R. § 803.9 – the Medical Device Reporting (MDR) “exemptions” provision, which waives adverse‐event‐reporting requirements for certain low‐risk device types. • 21 C.F.R. Part 822, Subpart B – the Postmarket Surveillance (§ 522) exemption criteria, under which manufacturers of many implanted and life‐sustaining devices escape mandatory real‐world monitoring. • FDA’s Real-World Evidence (RWE) Program Guidance – the draft/final guidance that makes RWE collection voluntary and pilot‐based rather than a universal postmarket requirement.

“Outdated Device Reporting Exemptions & Voluntary RWE Program”

Current FDA rules exempt many class I and II devices from mandatory Medical Device Reporting (§ 803.9) and allow manufacturers to forgo § 522 postmarket‐surveillance studies (Part 822, Subpart B). Meanwhile, the agency’s Real-World Evidence Program Guidance treats RWE as optional. Rescinding these carve-outs will require all manufacturers to report adverse events, compel real‐world surveillance for high-risk implants, and mandate systematic RWE collection—closing gaps that let unsafe or ineffective diagnostics and devices remain on the market unmonitored.

Department of Health & Human Services Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

(301) 492-4305 (410) 786-1524 (410) 786-8437

In 1995, FDA finalized 21 C.F.R. § 803.9 to lift MDR obligations from dozens of low-risk device categories, believing they posed minimal public‐health risk. In 1997, Section 522 rulemaking (21 C.F.R. Part 822) created an exemption track (Subpart B) so that many implantable or life-sustaining devices escaped real-world‐use studies. Most recently, FDA’s RWE Program Guidance (2018 draft, 2021 final) offered voluntary frameworks rather than binding requirements for manufacturers to harness claims, registry, or electronic health-record data.

• § 803.9: Eliminating the MDR exemption forces every device maker—regardless of class—to report serious injuries, deaths, and malfunctions, ensuring no safety signal slips through. • Part 822, Subpart B: Deleting the exemption track makes § 522 postmarket‐surveillance studies mandatory for all devices designated under the “implanted” or “life-sustaining” categories. • RWE Guidance: Rescinding the voluntary framework compels FDA to issue binding regulation requiring systematic RWE collection and periodic submissions of real-world performance data for moderate- and high-risk devices and diagnostics.

— 21 C.F.R. § 803.9 deleted; no device is exempt from MDR—every manufacturer must file reports for deaths, serious injuries, or malfunctions. — 21 C.F.R. Part 822, Subpart B removed; all § 522 orders apply wherever the agency designates a device for postmarket-surveillance, with no exemption path. — RWE Guidance rescinded; replaced by a forthcoming rule under 21 C.F.R. § 814.82 mandating real-world evidence plans and periodic data submissions tied to each device’s risk class.

Robert F. Kennedy Jr.

Secretary of Health and Human Services