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Stephanie McArdle

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FDA Compliance

FDA to Sunset Alternative Summary Reporting Program

The agency seeks to balance expedient exemptions against public transparency about medical devices

Published: Tuesday, July 23, 2019 - 12:02

The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.

The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted medical device manufacturers to send the FDA an accounting of device injuries and malfunctions on a periodic basis (e.g., quarterly or annually) in lieu of fulfilling their standard public reporting obligations. The ASR program actually ended in 2017, but evidence shows that device exemptions were still accepted by the FDA.

The impetus for ending ASR

The decision to end the alternative summary reporting program follows a recent Kaiser Health News (KHN) investigation. Survey results highlighted the collection of 1.1 million reports through the alternative summary program since 2016. FDA data provided to KHN shows that during the first nine months of 2018, the FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under exemption through the alternative reporting program.

The story illuminates a lack of public knowledge about products that physicians and healthcare professionals use every day. It is understandably worrying for practitioners when making decisions for purchasing products.

Not much information is forthcoming in terms of specific products involved, as well as the companies who’ve gained the exemption. However, the change in transparency with the end of ASR should help reduce concerns from healthcare practitioners who would potentially make decisions on product buying.

Exemptions are still possible

The FDA maintains that all alternative summary reporting data since 2017, except for Postmarket Spreadsheet Reports, are currently available in MAUDE (Manufacturer and User Facility Device Experience), the FDA’s public database. The FDA also says it has ended the Postmarket Spreadsheet Reports, which were designed for the efficient review of adverse events linked to silicone breast implants.

The FDA regulations require physicians and others to input adverse events into MAUDE unless the medical device manufacturer or another interested party can find an exemption from the rule. In certain cases, device makers will still be able to request exemptions or alternatives to reporting requirements.

“By law, a manufacturer may request, under 21 CFR 803.19, an exemption, variance, or alternative to reporting requirements under 21 CFR Part 803,” notes the FDA. “These requests will continue to be considered on a case-by-case basis going forward but will include conditions of approval that will ensure availability of data to the public online.” Without these exemptions, medical device manufacturers may fear that too much insight into problems they are already trying to fix may open the door for litigation.

Conclusion

In summary, it’s important to stay relevant to the FDA reporting requirements and mechanisms. The FDA should act in the interests of the public it serves by promoting transparency. Manufacturers should practice automated electronic submissions of MedWatch 3500A as part of an integrated quality management system that proactively drives the collection, investigation, and documentation of all postmarket issues and actions.

First published June 18, 2019, on the AssurX blog.

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About The Author

Stephanie McArdle’s default image

Stephanie McArdle

Stephanie McArdle is the vice president for product management for the life sciences industry at AssurX.