Apple puts onus of FDA clearance on iPhone developers

By: Brian Dolan | Jun 9, 2009        

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FDAThe U.S. Food and Drug Administration has indicated in the past that under certain circumstances the iPhone may be considered a medical device and therefore regulated as one, however, as of February the FDA still hadn’t figured out exactly which circumstances those might be.

Turns out Apple isn’t waiting around for the FDA. iPhone application developer and GraniteKey COO Mike Ahmadi wrote in to point out that Apple’s iPhone developer agreement includes a special section that puts the regulatory onus, in particular the duty of ensuring FDA compliance, on the developers themselves. 

Obviously this section of the agreement has become increasingly important since Apple began promoting connected peripheral devices and medical apps like LifeScan’s glucometer and AirStrip’s cardiac monitoring application at the company’s iPhone 3.0 and World Wide Developer Conference events.

Under the developer agreement section labeled “Regulatory Compliance for Health, Medical and Related Apps,” Apple writes: “You agree that You will not seek any regulatory marketing permissions or make any determinations that may result in any Apple products being deemed regulated or that may impose any obligations or limitations on Apple. By submitting Your Application to Apple for selection for distribution via the App Store, You represent and warrant that You are in full compliance with any applicable laws, regulations, and policies, including but not limited to all FDA laws, regulations and policies….”

Read on for the entire section related to regulatory compliance for health and medical apps.

Regulatory Compliance for Health, Medical and Related Apps:

3.3.19 You will fulfill any applicable regulatory requirements, including full compliance with all applicable laws, regulations, and policies related to the manufacturing, marketing, sale and distribution of Your Application in the United States, and in particular the requirements of the U.S. Food and Drug Administration (“FDA”), and the laws, regulations and policies of any other applicable regulatory bodies in any countries or territories where You use or make Your Application available. However, You agree that You will not seek any regulatory marketing permissions or make any determinations that may result in any Apple products being deemed regulated or that may impose any obligations or limitations on Apple. By submitting Your Application to Apple for selection for distribution via the App Store, You represent and warrant that You are in full compliance with any applicable laws, regulations, and policies, including but not limited to all FDA laws, regulations and policies, related to the manufacturing, marketing, sale and distribution of Your Application in the United States, as well as in other countries or territories where You plan to make Your Application available via the App Store. You also represent and warrant that You will market Your Application only for its cleared or approved intended use/indication for use, and only in strict compliance with applicable regulatory requirements. You agree to promptly notify Apple in accordance with the procedures set forth in Section 15.6 of any complaints or threats of complaints regarding Your Application in relation to any such regulatory requirements, in which case Apple may remove Your Application from the App Store.