Improving Medical Device Innovation Act
Latest action. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Improving Medical Device Innovation Act
This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to medical device performance standards, reporting requirements, and classification panels.
A person may request that the Food and Drug Administration (FDA) recognize a performance standard established by a recognized standards organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales.)
The FDA must:
train employees who review premarket submissions for medical devices on recognized standards;
review its published principles for recognizing standards;
identify types of medical devices for which a premarket report is no longer needed to provide reasonable assurance of safety and effectiveness;
ensure that adequate expertise is represented on medical device classification panels;
provide an opportunity for a person whose premarket submission is subject to review by a classification panel to recommend expertise needed on the panel; and
provide opportunities for patients, patient representatives, and medical device sponsors to recommend individuals for positions on classification panels.
The FDA, in coordination with medical device manufacturers, must establish pilot projects to evaluate alternative methods of compliance with reporting requirements for certain medical devices. The Government Accountability Office must report on these pilot projects.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in Senate" stage on March 17, 2016. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
4 steps remain before this bill could become law.
The record's latest action, on March 17, 2016: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the Senate
- Passage by the House
- The President's signature. If the President vetoes it, two-thirds of both chambers must vote to override.
How likely is it to become law?
Civibrief does not forecast outcomes and this page has no opinion about this one. What the record supports is a base rate, which is a fact about the whole pile, not a prediction about this measure.
In the 114th Congress (2015-16), 329 of the 10,233 bills and joint resolutions introduced became law, about 3.2 percent. That count covers every measure at every stage, including the many that never left committee.
This one is not there yet: 4 steps are still outstanding, listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
Amy Klobuchar (D-MN) introduced it on March 17, 2016, and 1 member has since signed on as a cosponsor.
They are 1 Republican.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on March 17, 2016, 3829 days ago. The most recent recorded action was 3829 days ago, on March 17, 2016.
Measures do not carry over. Anything the 114th Congress has not finished by January 3, 2017 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- SenateIn committee, no floor vote yet
- HouseAwaits Senate passage
- PresidentAwaits both chambers