FDA Seeks to Pump Up Interest in MDSAP Program

The FDA hasn’t seen the expected number of industry participants in the Medical Device Single Audit Program pilot, and is hoping to attract volunteers as it eyes a Jan. 1, 2017, launch date.

The information comes from a mid-pilot report released ahead of last week’s meeting of the International Medical Device Regulators Forum on the status of MDSAP, which is intended to decrease the number of regulatory audits.

Picking Up Steam?

As of July 23, 45 sites have expressed an interest in participating in the program; the target for the end of 2016 is 330 sites.

While the FDA has seen encouraging signs in terms of participation, with 20 sites signing up in July alone, there have been six months over the last year during which no volunteers came on board.

Another highlight of the status report was an update on identifying potential weaknesses of the program. During a June 23 forum, regulators, auditing organizations and manufacturers identified 15 areas of concern and 46 specific tasks intended to rectify them. IMDRF teams are reviewing the feasibility of these solutions.

In addition, IMDRF has created a quality management system that includes policies and procedures for complaints and feedback. The body encourages stakeholders to use process defined in the QMS to communicate concerns.

The organizations participating in MDSAP are the FDA, Health Canada, Australia’s Therapeutics Goods Administration, Brazil’s Agência Nacional de Vigilância Sanitária and Japan’s Ministry of Health, Labor and Welfare and the Pharmaceuticals and Medical Devices Agency. The EU signed up as an official observer in March (IDDM, March 20).

The status report is available here: www.fdanews.com/092115-mdsap-review.pdf. — Elizabeth Hollis