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# Apple Clearances Timing Raises Questions
- URL: https://www.fdaweb.com/apple-clearances-timing-raises-questions/
- Published: 2018-09-18T12:00:00.000Z
- Updated: 2026-09-15T00:32:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142378

Attorney **Bradley Thompson** (Epstein Becker Green) says some medical device industry people are concerned about the FDA 9/11 clearance of two Apple products that came one day before a company launch event for the products. Writing in an online [post](https://www.linkedin.com/pulse/fdas-dramatic-announcement-apples-clearances-level-thompson-rac?ref=fdaweb.com), Thompson says that while the agency’s goal for average total time to decision on 510(k) submissions is 124 days this year, the two Apple clearances were cleared in about 30 days. “That’s remarkable,” he says.

To further the concern about FDA and Apple working together, Thompson references a 9/12 FDA [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm?ref=fdaweb.com) supporting what Apple was doing with its cleared atrial fibrillation-detecting algorithm and its Series 4 Apple Watch with a built-in electrocardiogram.

“I am focused less on the duration of FDA’s review, because I don’t know what went on during the years before,” Thompson writes, “and more on the timing of the two decisions. While the two FDA letters are dated 9/11, it looks to me like they might’ve been posted to the FDA Website on 9/12, the exact same day as Apple’s event. Certainly that’s when FDA issued its press release announcing the clearances. So I have to ask myself, how that could happen?”

He said that while some industry observers have suggested that Apple’s regulatory advisors are just that good, “it would be truly phenomenal if any human being on earth could predict that FDA would clear one submission in exactly 33 days, and the other in exactly 28 days, when the average of such submissions is 150 days. That would be a pretty neat trick.”

He asked agency policymakers whether there was a new policy about timing of approvals to support pre-existing company-selected new product launch dates, and heard nothing back, he says. However, *MobiHealthNews* heard from the agency’s media affairs office that “FDA is suggesting that Apple is just that good.” The agency response indicated that the clearances were made independent of the company’s decision to announce the products’ marketing authorization or availability. “We are to believe that the two occurred within hours of each other as a coincidence, even though Apple’s marketing event had been announced long ago and FDA’s clearance decision occurred about 120 days quicker than average,” Thompson concludes. “The coincidence is simply too extraordinary for me to accept. I honestly thought FDA would offer some explanation for why it felt it could and should coordinate its announcement with Apple’s. I was hoping there was a new policy at FDA regarding the timing of agency clearance decisions in coordination with company marketing events that all manufacturers could utilize. Apparently not so. I am going to continue to press the agency for a better explanation.”