Pharmaceutical Apps and the US Regulatory Requirements

eHealth Law and Policy June 2015

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in eHealth Law and Policy, titled “Pharmaceutical Apps and the US Regulatory Requirements.”

Following is an excerpt:

The FDA has been very active in clarifying its approach to mobile apps. In February 2015, the FDA updated its guidance on Mobile Medical Apps (‘MMA Guidance’), originally published in September 20131. Many of the changes were designed to incorporate the FDA’s new approach to medical device data systems, published in a new guidance document at about the same time. Under that new approach, referred to as ‘enforcement discretion,’ the FDA has decided that it is not worth the resources to impose regulatory requirements on systems that merely store, transfer or display medical device data.

Many people find the concept of enforcement discretion confusing. On the one hand, the FDA is retaining the regulation on its books that would place medical device data systems (or ‘MDDS’) in class I, and require manufacturers of such systems to use a quality system. On the other hand, the FDA is saying it does not intend to enforce that requirement. So what do companies do? My recommendation is to consider product liability, and be guided by a risk analysis to decide whether a quality system is necessary for their MDDS products.