A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications.

Summary

This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding Food and Drug Administration (FDA): (1) inspections of establishments that manufacture or process medical devices, and (2) certification of medical devices for export. The biannual inspection schedule for medical device establishments handling higher risk devices is replaced with a risk-based schedule. In establishing the risk-based schedule, the FDA must consider an establishment's participation in international medical device audit programs. The FDA must adopt a uniform process and uniform standards for inspections of domestic and foreign medical device establishments. Upon request, the FDA must provide to the person in charge of a medical device establishment feedback regarding the person's proposals to address issues identified during an inspection. The FDA must provide the basis for denying requests for certification of products for export as meeting FDA requirements for domestic products. A person denied such a certification may request supervisory review of that decision. Products from a medical device establishment that an inspector found to be contaminated or insanitary may be certified for export if the person in charge of the establishment has agreed to a plan to correct the issues identified during the inspection.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 15 February 2017

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 15 February 2017

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 15 February 2017 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 15 February 2017

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 15 February 2017

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 15 February 2017

  Open at official source

Sponsors

• Sen. Isakson, Johnny [R-GA] · R · Sponsor
• Michael Bennet · D · Sponsor
• Todd Young · R · Cosponsor
• Sen. Donnelly, Joe [D-IN] · D · Cosponsor
• · sshr00 · Standing

Related records

• related to ← To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.